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

NCT02186015 | Completed Phase 2 Results

• 1 other identifier: 206519
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Women; Metastatic Breast Cancer; Estrogen Receptor Positive

Keywords

Metastatic Breast Cancer; MBC; Vitamin D Supplementation; Symptom Management

Outcome Measures

Primary Outcomes (1)

• Change in Serum 25(OH)D

  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.

  0, 8 weeks

Secondary Outcomes (7)

• Change in Worst Pain Rating From the Beck Pain Scale

  0, 8 weeks

• Change in Fatigue

  0, 8 weeks

• Change in Mood

  0, 8 weeks

• Change in Muscle Function

  0, 8 weeks

• Change in Sleep Quality Assessment

  0, 8 weeks

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.

Drug: Cholecalciferol

Vitamin D sufficient

NO INTERVENTION

All participants were ineligible for the intervention due to sufficient serum 25(OH)D levels at screening/baseline.

Interventions

Cholecalciferol DRUG

Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.

Also known as: Vitamin D3, Vitamin D

Cholecalciferol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic breast cancer (Stage IV)
• Histologically confirmed estrogen receptor positive disease
• Female
• Serum 25(OH) \<30 ng/ml
• Age ≥ 18 years
• Pre or post-menopausal
• ECOG Performance status 0-2
• Adequate organ function as defined as GFR\> 30 mls/min and serum calcium ≤ 10.4 mg/dl
• Any race/ethnicity
• English speaking
• No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician
• Willingness to sign a written informed consent and complete questionnaires
• Cease ingestion of vitamin D supplementation not study related

You may not qualify if:

• Women with Stage I-III breast cancer
• Serum 25(OH)D levels ≥ 30 ng/ml
• Untreated CNS involvement
• History of kidney stones
• History of renal failure
• History of hyperparathyroidism
• History of hypersensitivity to vitamin D
• Non-English speaking
• Currently pregnant or lactating, or anticipating pregnancy
• Unwilling to cease ingestion of calcium supplements (\>1000 mg/d)
• Unwilling or unable to complete informed consent or study questionnaires
• Psychiatric or other clinical conditions that preclude study compliance
• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Patricia Sheean
• Organization: Loyola University Chicago

psheean1@luc.edu

708-216-0344

Study Officials

• Patricia M Sheean, Ph.D., R.D.

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: February 1, 2015
• Primary Completion: March 8, 2017
• Study Completion: November 9, 2017
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-05

Locations

US (1)