Trial Outcomes & Findings for Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) (NCT NCT02186015)

Last Updated: 2021-05-14

Results Overview

Change in laboratory serum value of 25(OH)D at 8 weeks post-supplementation for participants who received weekly supplementation of 50,000 IUs of vitamin D3. Change is expressed as laboratory serum value of 25(OH)D at 8 weeks minus baseline. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

0, 8 weeks

Results posted on

2021-05-14

Participant Flow

Participants were recruited from a single cancer center and required to be: 1) \>18 years of age, 2) English speaking, 3) at a performance status of 0-2, 4) receiving treatment for histologically confirmed ER+ metastatic BC, and 5) clinically stable as judged by their medical oncologist.

Participant milestones

Participant milestones
Measure	Cholecalciferol All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Overall Study STARTED	11	31
Overall Study COMPLETED	10	31
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cholecalciferol All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Overall Study Physician Decision	1	0

Baseline Characteristics

Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholecalciferol n=11 Participants Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks	No Cholecalciferol n=31 Participants Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic White	5 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants
Employment status Paid full- or part-time work	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Employment status Retired without disability	1 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants
Employment status Retired with disability	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Employment status Unemployed	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Body mass index	27.3 kg/m^2 n=5 Participants	27.8 kg/m^2 n=7 Participants	27.5 kg/m^2 n=5 Participants
Stage IV at diagnosis Yes	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Stage IV at diagnosis No	7 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants
Duration of metastatic breast cancer	7 months n=5 Participants	19 months n=7 Participants	13 months n=5 Participants
Metastatic sites 1 or 2	9 Participants n=5 Participants	25 Participants n=7 Participants	34 Participants n=5 Participants
Metastatic sites Greater than 2	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Eastern Cooperative Oncology Group 0	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Eastern Cooperative Oncology Group 1	6 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants
Eastern Cooperative Oncology Group 2	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Radiation therapy for metastates Yes	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Radiation therapy for metastates No	8 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants
Surgery for breast cancer None	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Surgery for breast cancer Lumpectomy	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants
Surgery for breast cancer Mastectomy	1 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants
Serum 25(OH)D	17 ng/ml n=5 Participants	38 ng/ml n=7 Participants	34 ng/ml n=5 Participants

PRIMARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have laboratory serum value of 25(OH)D at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Serum 25(OH)D	32 ng/ml Interval 22.0 to 40.0	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Assessment of pain using the Beck Pain Scale at weeks 0 and 8. This is a Likert scale item where a score of 0 corresponds to no pain and a score of 10 corresponds to worst pain. Change is calculated as the worst pain rating at 8 weeks minus the worst pain rating at 0 weeks.Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Worst Pain Rating From the Beck Pain Scale	0 score on a scale Interval -3.0 to 0.0	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have assessment of fatigue at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of fatigue using the Piper Fatigue Scale at weeks 0 and 8. The Piper Fatigue Scale is the average of 22 numeric items, with higher scores indicating greater fatigue \[range of scores: 0-10\]. Change is calculated as the fatigue score at 8 weeks minus fatigue score at 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Fatigue	-0.5 units on a scale Interval -1.7 to 0.1	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have assessment of mood at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of mood using the Patient Health Questionnaire 8 (PHQ-8) at weeks 0 and 8. The PHQ-8 ranges from 0-24 with higher scores indicating more distress. Change was assessed as PHQ-8 score at 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Mood	-1 score on a scale Interval -4.0 to 2.0	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have hand dynamometer data at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of muscle function using a hand dynamometer at weeks 0 and 8. Change in dominant handgrip strength in kilograms was calculated as 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Muscle Function	-0.2 kilograms Interval -1.0 to 7.3	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did report the Pittsburgh Sleep Quality Index at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of sleep using the Pittsburgh Sleep Quality Index (PSQI) at weeks 0 and 8. Scores range from 0-21 with higher scores indicating poorer sleep quality. Change was calculated as week 8 minus week 0 PSQI. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Sleep Quality Assessment	-1 score on a scale Interval -4.0 to 4.0	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have the Functional assessment of cancer therapy-breast at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of quality of life using the functional assessment of cancer therapy-breast symptoms at weeks 0 and 8. Scores range from 0-40 with higher scores indicating better quality of life. Change was calculated as week 8 score minus week 0 score. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Functional Assessment of Cancer Therapy-breast	0 score on a scale Interval -7.0 to 17.0	—

SECONDARY outcome

Timeframe: 0, 8 weeks

Population: 1 participant who initiated supplementation of cholecalciferol did not have the Functional assessment of cancer therapy-endocrine at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.

Assessment of quality of life using the functional assessment of cancer therapy- endocrine symptoms at weeks 0 and 8. Scores range from 0-76 with higher scores indicating better quality of life. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=10 Participants Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.	No Cholecalciferol Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Change in Functional Assessment of Cancer Therapy-endocrine	9 score on a scale Interval -2.0 to 14.0	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=11 participants at risk Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks	No Intervention n=31 participants at risk Enrolled women without serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
Gastrointestinal disorders Nausea	27.3% 3/11 • Number of events 3 • 8 weeks	0.00% 0/31 • 8 weeks
Infections and infestations Upper respiratory infection	18.2% 2/11 • Number of events 2 • 8 weeks	0.00% 0/31 • 8 weeks

Additional Information

Patricia Sheean

Loyola University Chicago

Phone: 708-216-0344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place