Study on the Impact of Vitamin D Supplements on Cancer Treatment Response in Patients with Vitamin D Deficiency

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04677816

Provider View

This clinical trial is exploring whether taking vitamin D supplements can improve the effectiveness of chemotherapy in patients with vitamin D deficiency and triple negative breast cancer. The study also includes an observational group of patients who are not vitamin D deficient to compare responses.

Patient Parameters

Program Overview

The aim of this study is to find out if adding vitamin D supplements to standard chemotherapy can help patients with triple negative breast cancer who are vitamin D deficient achieve better treatment outcomes. Researchers believe that vitamin D supplements might increase the rate of complete cancer response to levels similar to those in patients with normal vitamin D levels, based on past data.

Description

The main goal of this study is to see if vitamin D supplements can help patients with vitamin D deficiency and triple negative breast cancer achieve a complete response to chemotherapy, meaning no signs of cancer remain. Researchers are looking to see if this response rate is 60% or higher, compared to 30% in past studies without vitamin D supplements.

Other goals include:

  • Estimating how much cancer remains in patients after treatment.
  • Observing the response in patients with normal vitamin D levels who receive chemotherapy.
  • Checking if it's feasible and safe to give vitamin D supplements with chemotherapy.
  • Measuring changes in vitamin D receptor levels in cancer tissue before and after treatment.
  • Studying changes in gut and breast tissue bacteria in patients before and after treatment.

Participants will be monitored for at least 30 days after their last treatment for any side effects. They will continue to be followed for 30 days after leaving the study or until they pass away, whichever comes first. If a participant experiences severe side effects, they will be monitored until the side effects improve or stabilize.

Eligibility Criteria

Inclusion Criteria

  • Adults (18 years or older) with confirmed invasive breast cancer.
  • Cancer must be triple negative, meaning it does not have estrogen, progesterone, or HER2 receptors.
  • Scheduled for surgery (lumpectomy or mastectomy) after chemotherapy.
  • Good overall health with a performance status of 0, 1, or 2.
  • Women of childbearing age must use effective birth control during the study.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • History of kidney stones in the past year.
  • Known sarcoidosis (a type of inflammatory disease).
  • High calcium levels in the blood.
  • Allergic reactions to vitamin D or similar substances.
  • Pregnant or breastfeeding women.
  • Previous treatment for this cancer, including surgery, radiation, or chemotherapy.
  • Currently taking high doses of vitamin D (50,000 IU weekly).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.