Trial Outcomes & Findings for Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy (NCT NCT01422408)

Results Overview

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2017-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Supportive Care (Fluocinonide Cream) This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Supportive Care (Fluocinonide Cream) This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	55.44 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Menopause status Pre-menopausal	1 Participants n=5 Participants
Menopause status Post-menopausal	33 Participants n=5 Participants
Current endocrine therapy Anastrazole	7 Participants n=5 Participants
Current endocrine therapy Exemestane	3 Participants n=5 Participants
Current endocrine therapy Letrozole	13 Participants n=5 Participants
Current endocrine therapy Tamoxifen	11 Participants n=5 Participants
Prior cytotoxic chemotherapy received Prior cytotoxic chemotherapy	14 Participants n=5 Participants
Prior cytotoxic chemotherapy received No prior cytotoxic chemotherapy	20 Participants n=5 Participants
Indications for endocrine therapy Adjuvant	33 Participants n=5 Participants
Indications for endocrine therapy Prophylaxis	1 Participants n=5 Participants
Severe baseline symptoms, Dryness Severe	15 Participants n=5 Participants
Severe baseline symptoms, Dryness Not severe	19 Participants n=5 Participants
Severe baseline symptoms, Dyspareunia Severe	15 Participants n=5 Participants
Severe baseline symptoms, Dyspareunia Not severe	10 Participants n=5 Participants
Severe baseline symptoms, Dyspareunia Missing/not reported	9 Participants n=5 Participants
Severe baseline symptoms, Itching Severe	1 Participants n=5 Participants
Severe baseline symptoms, Itching Not severe	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Symptom Scores of Vaginal Dryness	-2 units on a scale Interval -3.0 to -1.0

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Symptom Scores of Dyspareunia	-2 units on a scale Interval -3.0 to -1.8

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Symptom Scores of Vaginal Itching	-1 units on a scale Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Total Vaginal Index Score.	-5 units on a scale Interval -6.0 to -3.8

SECONDARY outcome

Timeframe: Over 4 weeks

Population: Toxicity and safety analyses will be conducted using the safety analysis set.

Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Number of Patients Experiencing Toxicities	1 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Age Characteristics Age 18-45	-1.5 units on a scale Interval -2.5 to -1.0
Change in Vaginal Dryness Symptom Scores by Age Characteristics Age 46-55	-2.0 units on a scale Interval -3.0 to -2.0
Change in Vaginal Dryness Symptom Scores by Age Characteristics Age 56-65	-2.0 units on a scale Interval -2.0 to -1.5
Change in Vaginal Dryness Symptom Scores by Age Characteristics Age > 65	-2.0 units on a scale Interval -3.0 to -0.75

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Age Characteristics Age 18-45	-1 units on a scale Interval -1.0 to -1.0
Change in Dyspareunia Symptom Scores by Age Characteristics Age 46-55	-2 units on a scale Interval -2.0 to -2.0
Change in Dyspareunia Symptom Scores by Age Characteristics Age 56-65	-2.5 units on a scale Interval -3.0 to -1.75
Change in Dyspareunia Symptom Scores by Age Characteristics Age > 65	-3 units on a scale Interval -3.0 to -3.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Age Characteristics Age 18-45	-0.5 units on a scale Interval -1.25 to 0.25
Change in Vaginal Itching Symptom Scores by Age Characteristics Age 46-55	-1 units on a scale Interval -2.0 to 0.0
Change in Vaginal Itching Symptom Scores by Age Characteristics Age 56-65	-1 units on a scale Interval -1.75 to 0.0
Change in Vaginal Itching Symptom Scores by Age Characteristics Age > 65	-0.5 units on a scale Interval -1.25 to 0.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics Pre-Menopause	-2 units on a scale Interval -2.0 to -2.0
Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics Post-menopause	-2 units on a scale Interval -3.0 to -1.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Menopause Status Characteristics Pre-Menopause	NA units on a scale Missing data for the one subject in this group.
Change in Dyspareunia Symptom Scores by Menopause Status Characteristics Post-menopause	-2 units on a scale Interval -3.0 to -1.75

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics Pre-Menopause	-1 units on a scale Interval -1.0 to -1.0
Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics Post-menopause	-1 units on a scale Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics Anastrazole	-2 units on a scale Interval -2.75 to -2.0
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics Exemestane	-2 units on a scale Interval -2.5 to -1.5
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics Letrozole	-2 units on a scale Interval -3.0 to -1.0
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics Tamoxifen	-2 units on a scale Interval -2.0 to -1.25

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics Anastrazole	-2 units on a scale Interval -2.5 to -1.5
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics Exemestane	-2 units on a scale Interval -2.0 to -2.0
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics Letrozole	-2.5 units on a scale Interval -3.0 to -2.0
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics Tamoxifen	-1.5 units on a scale Interval -1.75 to -1.25

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics Exemestane	-1 units on a scale Interval -1.5 to -0.5
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics Anastrazole	-0.5 units on a scale Interval -1.0 to 0.0
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics Letrozole	-0.5 units on a scale Interval -2.0 to 0.0
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics Tamoxifen	-1 units on a scale Interval -1.75 to -1.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics Yes	-2 units on a scale Interval -2.0 to -1.0
Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics No	-2 units on a scale Interval -3.0 to -1.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics Yes	-2 units on a scale Interval -2.25 to -1.0
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics No	-2.5 units on a scale Interval -3.0 to -2.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics Yes	-1 units on a scale Interval -1.0 to 0.0
Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics No	-1 units on a scale Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics Adjuvant	-2 units on a scale Interval -2.5 to -1.0
Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics Prophylaxis	-3 units on a scale Interval -3.0 to -3.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics Adjuvant	-2 units on a scale Interval -3.0 to -1.75
Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics Prophylaxis	NA units on a scale Data for single participant is missing

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics Adjuvant	-1 units on a scale Interval -1.75 to 0.0
Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics Prophylaxis	-2 units on a scale Interval -2.0 to -2.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics 50 - 74%	-2 units on a scale Interval -2.0 to -2.0
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics >= 75%	-2 units on a scale Interval -3.0 to -1.0
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics Missing / not reported	NA units on a scale Data is missing for these patients

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics >= 75%	-2 units on a scale Interval -3.0 to -1.75
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics 50 - 74%	NA units on a scale Data is missing; could not calculate
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics Missing / not reported	NA units on a scale Data is missing; could not calculate

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics 50 - 74%	-1 units on a scale Interval -1.0 to -1.0
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics >= 75%	-1 units on a scale Interval -2.0 to 0.0
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics Missing / not reported	NA units on a scale Data is missing; could not calculate.

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics < 25%	-1 units on a scale Interval -1.0 to -1.0
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics 25 - 49%	-2 units on a scale Interval -3.0 to -1.75
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics 50 - 74%	-2 units on a scale Interval -3.0 to -1.75
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics >= 75%	-2 units on a scale Interval -2.0 to -2.0
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics Missing / not reported	-2.5 units on a scale Interval -3.25 to -1.75

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics < 25%	-1 units on a scale Interval -1.0 to -1.0
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics 25 - 49%	-2 units on a scale Interval -2.5 to -1.5
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics 50 - 74%	-2 units on a scale Interval -2.25 to -1.75
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics >= 75%	-2 units on a scale Interval -2.25 to -2.0
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics Missing / not reported	-3 units on a scale Interval -3.0 to -3.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

Outcome measures

Outcome measures
Measure	Supportive Care (Fluocinonide Cream) n=34 Participants This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics < 25%	-1 units on a scale Interval -1.0 to -1.0
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics 25 - 49%	-1 units on a scale Interval -2.0 to 0.0
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics 50 - 74%	0 units on a scale Interval -1.0 to 0.0
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics >= 75%	-1 units on a scale Interval -2.0 to -0.5
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics Missing / not reported	-1 units on a scale Interval -1.5 to -0.5

Adverse Events

Supportive Care (Fluocinonide Cream)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supportive Care (Fluocinonide Cream) n=34 participants at risk This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Skin and subcutaneous tissue disorders Vaginal inflammation	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Bullous dermatitis	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Flushing	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
General disorders Headache	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Pain of skin	67.6% 23/34 • Number of events 23 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Pruritis	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/34 • Number of events 1 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Skin and subcutaneous tissue disorders Vaginal discharge	5.9% 2/34 • Number of events 2 • End of study week 1, 2, 3, 4 Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).

Additional Information

Emile Latour

Knight Cancer Institute, Oregon Health & Science University

Phone: 503-418-9601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place