Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)
NCT ID: NCT02186015
Last Updated: 2021-05-14
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
43 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-02-28
Study Completion Date
2017-11-09
Brief Summary
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Background: Several clinical trials are underway to investigate if variable forms of vitamin D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer, specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a rapidly expanding sector of the cancer survivor population who experience significant treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to high calcium and importantly, in lab studies have shown that vitamin D3 affects a gene that increases estrogen production. To assure that vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplements on estrogen production requires an evaluation that further explores and defines its potential role in symptom management for this population.
Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in women with MBC, providing much needed data on the preliminary safety and efficacy of this treatment in this patient population. This study will determine: 1) if weekly supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved inflammation (exploratory aim.)
Methods: This is an 8 week "proof of concept" study to monitor laboratory parameters and to assess potential effects on short-term outcomes. Adult, female patients (\>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D \< 30 mg/dl will be recruited from within and around LUMC. Following current clinical practice guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks. Laboratory values, muscle function and inflammation will be examined pre- and post-supplementation, while symptoms will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if increases in vitamin D are associated with clinically significant improvements in symptoms and QOL, and decreased inflammation.
Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in women with MBC, providing much needed data on the preliminary safety and efficacy of this treatment in this patient population. This study will determine: 1) if weekly supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved inflammation (exploratory aim.)
Methods: This is an 8 week "proof of concept" study to monitor laboratory parameters and to assess potential effects on short-term outcomes. Adult, female patients (\>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D \< 30 mg/dl will be recruited from within and around LUMC. Following current clinical practice guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks. Laboratory values, muscle function and inflammation will be examined pre- and post-supplementation, while symptoms will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if increases in vitamin D are associated with clinically significant improvements in symptoms and QOL, and decreased inflammation.
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Detailed Description
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Study Aims
Several clinical trials are underway to investigate if vitamin D2 or D3 provided at various doses (10,000-50,000 IUs/week) can improve the side-effects associated with anti-estrogen therapies, specifically aromatase inhibitors (AIs). However, these current trials use variable forms of vitamin D and predominantly include women with Stage I-III disease, excluding women with metastatic breast cancer. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to hypercalcemia and importantly, in vitro studies have shown that vitamin D3 influences the transcription of a gene that increases estrogen production.27,28 To assure that vitamin D3 does not abrogate the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplementation on estrogen production requires evaluation. Therefore, the overarching goal of this pilot study is to evaluate the safety, feasibility and efficacy of vitamin D3 supplementation in women with MBC. We will address and test the following aims and hypotheses, respectively:
Aim 1: To determine if weekly supplementation of 50,000 IUs of vitamin D3 raises serum levels of 25(OH)D to \>30 mg/dl without adverse effects.
Hypothesis 1: Women who are compliant with vitamin D3 supplementation, as evidenced by normalization (\>30 mg/dl) or increases in their serum 25(OH)D levels, will not experience significant changes in serum calcium, parathyroid hormone or serum estradiol levels.
Aim 2: To determine the effect of vitamin D3 supplementation on symptom management.
Hypothesis 2: Women who achieve serum concentrations of 25 (OH)D ≥30 mg/dl or experience significant increases in 25(OH)D will exhibit improvements in pain, fatigue, sleep, mood, muscle function and overall quality of life.
Exploratory Aim: To explore the mechanistic effects of vitamin D3 supplementation on inflammatory markers and its potential association with symptom management.
Summary: Evidence from studies involving early stage breast cancer participants confirms that musculoskeletal pain, endocrine related symptoms and mood disturbances are commonly associated with breast cancer treatment, particularly hormone deprivation therapies. The high prevalence of vitamin D deficiency/insufficiency among breast cancer survivors is well accepted and further hypothesized to aggravate treatment-related side effects, particularly arthralgias. Women with MBC are excluded from the majority of on-going vitamin D supplementation trials for safety and generalizability purposes. However, novel therapies are continuing to improve and prolong the lives of these women, resulting in a rapidly expansive group of breast cancer survivors. While vitamin D supplementation is prescribed to correct an underlying nutrient deficiency in the clinical context of preserving bone health, emerging evidence suggests it may have more systemic effects. Thus, vitamin D repletion/supplementation has profound potential implications for women with MBC, whose primary goal of treatment is to minimize the side-effects of treatment in support of optimal quality of life. This study reflects a highly innovative, yet simple therapy that could ultimately provide these survivors with a much needed evidence-based supportive care strategies.
Several clinical trials are underway to investigate if vitamin D2 or D3 provided at various doses (10,000-50,000 IUs/week) can improve the side-effects associated with anti-estrogen therapies, specifically aromatase inhibitors (AIs). However, these current trials use variable forms of vitamin D and predominantly include women with Stage I-III disease, excluding women with metastatic breast cancer. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to hypercalcemia and importantly, in vitro studies have shown that vitamin D3 influences the transcription of a gene that increases estrogen production.27,28 To assure that vitamin D3 does not abrogate the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplementation on estrogen production requires evaluation. Therefore, the overarching goal of this pilot study is to evaluate the safety, feasibility and efficacy of vitamin D3 supplementation in women with MBC. We will address and test the following aims and hypotheses, respectively:
Aim 1: To determine if weekly supplementation of 50,000 IUs of vitamin D3 raises serum levels of 25(OH)D to \>30 mg/dl without adverse effects.
Hypothesis 1: Women who are compliant with vitamin D3 supplementation, as evidenced by normalization (\>30 mg/dl) or increases in their serum 25(OH)D levels, will not experience significant changes in serum calcium, parathyroid hormone or serum estradiol levels.
Aim 2: To determine the effect of vitamin D3 supplementation on symptom management.
Hypothesis 2: Women who achieve serum concentrations of 25 (OH)D ≥30 mg/dl or experience significant increases in 25(OH)D will exhibit improvements in pain, fatigue, sleep, mood, muscle function and overall quality of life.
Exploratory Aim: To explore the mechanistic effects of vitamin D3 supplementation on inflammatory markers and its potential association with symptom management.
Summary: Evidence from studies involving early stage breast cancer participants confirms that musculoskeletal pain, endocrine related symptoms and mood disturbances are commonly associated with breast cancer treatment, particularly hormone deprivation therapies. The high prevalence of vitamin D deficiency/insufficiency among breast cancer survivors is well accepted and further hypothesized to aggravate treatment-related side effects, particularly arthralgias. Women with MBC are excluded from the majority of on-going vitamin D supplementation trials for safety and generalizability purposes. However, novel therapies are continuing to improve and prolong the lives of these women, resulting in a rapidly expansive group of breast cancer survivors. While vitamin D supplementation is prescribed to correct an underlying nutrient deficiency in the clinical context of preserving bone health, emerging evidence suggests it may have more systemic effects. Thus, vitamin D repletion/supplementation has profound potential implications for women with MBC, whose primary goal of treatment is to minimize the side-effects of treatment in support of optimal quality of life. This study reflects a highly innovative, yet simple therapy that could ultimately provide these survivors with a much needed evidence-based supportive care strategies.
Conditions
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Adult Women
Metastatic Breast Cancer
Estrogen Receptor Positive
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Cholecalciferol
All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
Group Type
EXPERIMENTAL
Cholecalciferol
Intervention Type
DRUG
Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
Vitamin D sufficient
All participants were ineligible for the intervention due to sufficient serum 25(OH)D levels at screening/baseline.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Cholecalciferol
Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
Intervention Type
DRUG
Other Intervention Names
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Vitamin D3
Vitamin D
Eligibility Criteria
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Inclusion Criteria
1. Metastatic breast cancer (Stage IV)
2. Histologically confirmed estrogen receptor positive disease
3. Female
4. Serum 25(OH) \<30 ng/ml
5. Age ≥ 18 years
6. Pre or post-menopausal
7. ECOG Performance status 0-2
8. Adequate organ function as defined as GFR\> 30 mls/min and serum calcium ≤ 10.4 mg/dl
9. Any race/ethnicity
10. English speaking
11. No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician
12. Willingness to sign a written informed consent and complete questionnaires
13. Cease ingestion of vitamin D supplementation not study related
2. Histologically confirmed estrogen receptor positive disease
3. Female
4. Serum 25(OH) \<30 ng/ml
5. Age ≥ 18 years
6. Pre or post-menopausal
7. ECOG Performance status 0-2
8. Adequate organ function as defined as GFR\> 30 mls/min and serum calcium ≤ 10.4 mg/dl
9. Any race/ethnicity
10. English speaking
11. No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician
12. Willingness to sign a written informed consent and complete questionnaires
13. Cease ingestion of vitamin D supplementation not study related
Exclusion Criteria
1. Women with Stage I-III breast cancer
2. Serum 25(OH)D levels ≥ 30 ng/ml
3. Untreated CNS involvement
4. History of kidney stones
5. History of renal failure
6. History of hyperparathyroidism
7. History of hypersensitivity to vitamin D
8. Non-English speaking
9. Currently pregnant or lactating, or anticipating pregnancy
10. Unwilling to cease ingestion of calcium supplements (\>1000 mg/d)
11. Unwilling or unable to complete informed consent or study questionnaires
12. Psychiatric or other clinical conditions that preclude study compliance
13. Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities
2. Serum 25(OH)D levels ≥ 30 ng/ml
3. Untreated CNS involvement
4. History of kidney stones
5. History of renal failure
6. History of hyperparathyroidism
7. History of hypersensitivity to vitamin D
8. Non-English speaking
9. Currently pregnant or lactating, or anticipating pregnancy
10. Unwilling to cease ingestion of calcium supplements (\>1000 mg/d)
11. Unwilling or unable to complete informed consent or study questionnaires
12. Psychiatric or other clinical conditions that preclude study compliance
13. Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Loyola University
OTHER
Sponsor Role
lead
Responsible Party
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Patricia Sheean
Research Associate
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Patricia M Sheean, Ph.D., R.D.
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Site Status
Countries
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United States
References
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Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
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Maureen Sheean P, Robinson P, Bartolotta MB, Joyce C, Adams W, Penckofer S. Associations Between Cholecalciferol Supplementation and Self-Reported Symptoms Among Women With Metastatic Breast Cancer and Vitamin D Deficiency: A Pilot Study. Oncol Nurs Forum. 2021 May 1;48(3):352-360. doi: 10.1188/21.ONF.352-360.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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206519
Identifier Type: -
Identifier Source: org_study_id
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High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
NCT00263185
COMPLETED
EARLY_PHASE1
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
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RECRUITING
NA
Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
NCT02172651
RECRUITING
EARLY_PHASE1
High Dose Vitamin D vs Standard Dose Vitamin D Study
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TERMINATED
PHASE2
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
NCT01809171
TERMINATED
PHASE2/PHASE3
Vitamin D Supplementation in Breast Cancer Patients
NCT06596122
NOT_YET_RECRUITING
PHASE2
Vitamin D Levels in Stage IV Colorectal Cancer Patients
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COMPLETED
PHASE2
Vitamin D in Treating Patients With Prostate Cancer
NCT00524680
COMPLETED
PHASE2
Vitamin D, Diet and Activity Study
NCT01240213
COMPLETED
NA
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
NCT00068276
COMPLETED
PHASE2
Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation
NCT01447355
COMPLETED
PHASE1
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
NCT06642428
RECRUITING
NA
Vitamin D Supplementation in Women With DCIS and/or LCIS
NCT02936999
TERMINATED
EARLY_PHASE1
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
NCT00692120
COMPLETED
NA