Prostate Cancer Clinical Trial

High-dose Vitamin D Supplementation for ADT-induced Side Effects

Summary

The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.

View Full Description

Full Description

The investigators hypothesize high-dose vitamin D supplementation will reduce androgen deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among prostate cancer survivors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a confirmed diagnosis of stage I-IIIA prostate cancer
Within 6 months of starting ADT with an additional 6 more months planned.
Participants must have sub-optimal vitamin D levels of <32 ng/ml.
Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided.
Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl.
No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
Able to read English (since the assessment materials are in printed format).
Able to swallow medication and provide written informed consent.
60 years of age or older.

Exclusion Criteria:

Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
Patients with hypercalcemia (corrected serum Ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity.
Patients with impaired renal function (CrCl < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
Myocardial infarction within the past year.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

108

Study ID:

NCT02064946

Recruitment Status:

Completed

Sponsor:

University of Rochester

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Wilmot Cancer Center, University of Rochester
Rochester New York, 14624, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

108

Study ID:

NCT02064946

Recruitment Status:

Completed

Sponsor:


University of Rochester

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider