Trial Outcomes & Findings for Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer (NCT NCT02556632)
NCT ID: NCT02556632
Last Updated: 2017-11-06
Results Overview
The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Baseline up to 1 week post radiation therapy
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Arm I (Curcumin-based Gel)
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
62
|
|
Overall Study
COMPLETED
|
59
|
59
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
9
|
Reasons for withdrawal
| Measure |
Arm I (Curcumin-based Gel)
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Disliked Intervention
|
1
|
1
|
1
|
|
Overall Study
No Reason
|
1
|
0
|
1
|
|
Overall Study
Personal Issues
|
0
|
1
|
1
|
|
Overall Study
Changed Mind
|
0
|
1
|
0
|
|
Overall Study
Withdrew (Unrelated Medical)
|
1
|
0
|
0
|
|
Overall Study
Unrelated Adverse Event
|
1
|
0
|
3
|
|
Overall Study
Related Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Possibly Related Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Did Not Start RT
|
0
|
1
|
0
|
|
Overall Study
Ineligible
|
0
|
1
|
0
|
|
Overall Study
Disliked Study Procedures
|
0
|
0
|
1
|
|
Overall Study
Treatment or Change Delay
|
0
|
0
|
1
|
Baseline Characteristics
The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
Baseline characteristics by cohort
| Measure |
Arm I (Curcumin-based Gel)
n=64 Participants
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=65 Participants
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=62 Participants
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 11.2 • n=64 Participants
|
60.7 years
STANDARD_DEVIATION 10.5 • n=65 Participants
|
59.8 years
STANDARD_DEVIATION 9.3 • n=62 Participants
|
59.8 years
STANDARD_DEVIATION 10.3 • n=191 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=64 Participants
|
65 Participants
n=65 Participants
|
62 Participants
n=62 Participants
|
191 Participants
n=191 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=191 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=191 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=64 Participants
|
63 Participants
n=65 Participants
|
61 Participants
n=62 Participants
|
186 Participants
n=191 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
2 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=191 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=191 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=64 Participants
|
9 Participants
n=65 Participants
|
4 Participants
n=62 Participants
|
21 Participants
n=191 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=64 Participants
|
55 Participants
n=65 Participants
|
57 Participants
n=62 Participants
|
167 Participants
n=191 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=191 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=191 Participants
|
|
Marital Status
Married
|
45 Participants
n=64 Participants
|
37 Participants
n=65 Participants
|
37 Participants
n=62 Participants
|
119 Participants
n=191 Participants
|
|
Marital Status
Domestic Partner
|
0 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=191 Participants
|
|
Marital Status
Divorced
|
5 Participants
n=64 Participants
|
9 Participants
n=65 Participants
|
16 Participants
n=62 Participants
|
30 Participants
n=191 Participants
|
|
Marital Status
Separated
|
1 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Marital Status
Single
|
8 Participants
n=64 Participants
|
8 Participants
n=65 Participants
|
2 Participants
n=62 Participants
|
18 Participants
n=191 Participants
|
|
Marital Status
Widowed
|
5 Participants
n=64 Participants
|
10 Participants
n=65 Participants
|
4 Participants
n=62 Participants
|
19 Participants
n=191 Participants
|
|
Marital Status
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Stage of Disease
DCIS
|
5 Participants
n=64 Participants
|
12 Participants
n=65 Participants
|
11 Participants
n=62 Participants
|
28 Participants
n=191 Participants
|
|
Stage of Disease
Stage I
|
34 Participants
n=64 Participants
|
29 Participants
n=65 Participants
|
22 Participants
n=62 Participants
|
85 Participants
n=191 Participants
|
|
Stage of Disease
Stage II
|
16 Participants
n=64 Participants
|
18 Participants
n=65 Participants
|
20 Participants
n=62 Participants
|
54 Participants
n=191 Participants
|
|
Stage of Disease
Stage III
|
7 Participants
n=64 Participants
|
5 Participants
n=65 Participants
|
8 Participants
n=62 Participants
|
20 Participants
n=191 Participants
|
|
Stage of Disease
Stage IV
|
2 Participants
n=64 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Stage of Disease
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Location of Breast Cancer
Left
|
29 Participants
n=64 Participants
|
27 Participants
n=65 Participants
|
30 Participants
n=62 Participants
|
86 Participants
n=191 Participants
|
|
Location of Breast Cancer
Right
|
35 Participants
n=64 Participants
|
37 Participants
n=65 Participants
|
31 Participants
n=62 Participants
|
103 Participants
n=191 Participants
|
|
Location of Breast Cancer
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Prior Chemotherapy
No
|
30 Participants
n=64 Participants
|
35 Participants
n=65 Participants
|
34 Participants
n=62 Participants
|
99 Participants
n=191 Participants
|
|
Prior Chemotherapy
Yes
|
34 Participants
n=64 Participants
|
29 Participants
n=65 Participants
|
27 Participants
n=62 Participants
|
90 Participants
n=191 Participants
|
|
Prior Chemotherapy
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Currently on Hormone Therapy
No
|
52 Participants
n=64 Participants
|
48 Participants
n=65 Participants
|
48 Participants
n=62 Participants
|
148 Participants
n=191 Participants
|
|
Currently on Hormone Therapy
Yes
|
12 Participants
n=64 Participants
|
16 Participants
n=65 Participants
|
13 Participants
n=62 Participants
|
41 Participants
n=191 Participants
|
|
Currently on Hormone Therapy
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Currently on Herceptin Treatment
No
|
56 Participants
n=64 Participants
|
56 Participants
n=65 Participants
|
58 Participants
n=62 Participants
|
170 Participants
n=191 Participants
|
|
Currently on Herceptin Treatment
Yes
|
8 Participants
n=64 Participants
|
8 Participants
n=65 Participants
|
3 Participants
n=62 Participants
|
19 Participants
n=191 Participants
|
|
Currently on Herceptin Treatment
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Type of Radiation
IMRT
|
1 Participants
n=64 Participants
|
2 Participants
n=65 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=191 Participants
|
|
Type of Radiation
3D Conformal Whole Breast
|
63 Participants
n=64 Participants
|
62 Participants
n=65 Participants
|
59 Participants
n=62 Participants
|
184 Participants
n=191 Participants
|
|
Type of Radiation
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Radiation Boost Planned
No
|
4 Participants
n=64 Participants
|
3 Participants
n=65 Participants
|
2 Participants
n=62 Participants
|
9 Participants
n=191 Participants
|
|
Radiation Boost Planned
Yes
|
60 Participants
n=64 Participants
|
61 Participants
n=65 Participants
|
59 Participants
n=62 Participants
|
180 Participants
n=191 Participants
|
|
Radiation Boost Planned
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=191 Participants
|
|
Total Radiation Dose Prescribed
|
58.4 Gray units
STANDARD_DEVIATION 5.6 • n=64 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
59.5 Gray units
STANDARD_DEVIATION 4.5 • n=64 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
59.1 Gray units
STANDARD_DEVIATION 5.2 • n=61 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
59.0 Gray units
STANDARD_DEVIATION 5.1 • n=189 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
|
Breast Field Separation
|
22.6 centimeters
STANDARD_DEVIATION 4.0 • n=64 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
23.8 centimeters
STANDARD_DEVIATION 4.2 • n=64 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
22.8 centimeters
STANDARD_DEVIATION 5.5 • n=61 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
23.1 centimeters
STANDARD_DEVIATION 4.6 • n=189 Participants • The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out.
|
PRIMARY outcome
Timeframe: Baseline up to 1 week post radiation therapyPopulation: Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study
The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Outcome measures
| Measure |
Arm I (Curcumin-based Gel)
n=59 Participants
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=59 Participants
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=53 Participants
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)
|
2.68 units on a scale
Standard Deviation 0.74
|
2.64 units on a scale
Standard Deviation 0.74
|
2.63 units on a scale
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: Baseline up to completion of radiation therapyPopulation: Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study
The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.
Outcome measures
| Measure |
Arm I (Curcumin-based Gel)
n=59 Participants
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=59 Participants
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=53 Participants
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Incidence of Moist Desquamation (Present vs. Absent)
No Moist Desquamation
|
44 Participants
|
47 Participants
|
41 Participants
|
|
Incidence of Moist Desquamation (Present vs. Absent)
Moist Desquamation
|
15 Participants
|
12 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 1 week after completion of radiation therapyPopulation: Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post.
The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Outcome measures
| Measure |
Arm I (Curcumin-based Gel)
n=60 Participants
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=58 Participants
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=52 Participants
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)
|
2.25 units on a scale
Standard Deviation 0.99
|
2.16 units on a scale
Standard Deviation 0.92
|
2.15 units on a scale
Standard Deviation 0.96
|
Adverse Events
Arm I (Curcumin-based Gel)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II (HPR Plus)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm III (Placebo Gel)
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Curcumin-based Gel)
n=64 participants at risk
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=65 participants at risk
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=62 participants at risk
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiac disorders
Heart Failure
|
0.00%
0/64
|
1.5%
1/65
|
1.6%
1/62
|
|
Nervous system disorders
Headache
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
4.7%
3/64
|
1.5%
1/65
|
6.5%
4/62
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/64
|
1.5%
1/65
|
0.00%
0/62
|
Other adverse events
| Measure |
Arm I (Curcumin-based Gel)
n=64 participants at risk
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm II (HPR Plus)
n=65 participants at risk
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Dermatologic Complications Management: Apply HPR Plus topically
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
Arm III (Placebo Gel)
n=62 participants at risk
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Apply placebo gel topically
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythematous papular rash
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
Immune system disorders
Allergic reaction
|
1.6%
1/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.1%
2/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.7%
3/64
|
1.5%
1/65
|
1.6%
1/62
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
1/64
|
1.5%
1/65
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
0.00%
0/64
|
0.00%
0/65
|
3.2%
2/62
|
|
General disorders
Localized edema - Breast swelling
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
Reproductive system and breast disorders
Nipple pain
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
4.7%
3/64
|
1.5%
1/65
|
0.00%
0/62
|
|
General disorders
Pain
|
1.6%
1/64
|
1.5%
1/65
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders (Other, Specify)
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
Vascular disorders
Lymphedema
|
1.6%
1/64
|
0.00%
0/65
|
0.00%
0/62
|
|
General disorders
Fatigue
|
0.00%
0/64
|
1.5%
1/65
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
|
General disorders
Pain of skin
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Skin and subcutaneous tissue disorders
Papulpustular rash
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other: yellow colored bowel movements
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
|
Vascular disorders
Vascular disorders - Other: hellow colored hidrosis
|
0.00%
0/64
|
0.00%
0/65
|
1.6%
1/62
|
Additional Information
Julie Ryan Wolf, PhD, MPH; Associate Professor of Dermatology and Radiation Oncology
University of Rochester
Phone: 585-276-3862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place