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Chemotherapy

Vitamin D Supplementation for Breast Cancer

Phase 2

Recruiting

Led By Emily H Douglas, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

ECOG performance status of 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last day of study intervention

Awards & highlights

Study Summary

This trial is testing whether adding vitamin D to standard chemotherapy can improve outcomes in patients with vitamin D deficiency and triple-negative breast cancer.

Who is the study for?

This trial is for adults with triple negative breast cancer who are vitamin D deficient and scheduled for surgery after chemotherapy. They must be in good enough health to participate, agree to use contraception, and have not received prior treatment for their cancer. People with a history of kidney stones, sarcoidosis, high calcium levels, allergies to vitamin D-like compounds or taking high-dose Vitamin D cannot join.Check my eligibility

What is being tested?

The study tests if adding Vitamin D3 supplements to standard neoadjuvant chemotherapy improves the rate at which patients achieve complete absence of cancer in the breast tissue after treatment (pathologic complete response), compared to historical rates in patients with sufficient vitamin D.See study design

What are the potential side effects?

While this trial focuses on Vitamin D supplementation alongside chemotherapy, potential side effects may include typical reactions from chemo such as nausea, fatigue, hair loss and increased risk of infection. High doses of Vitamin D can cause issues like bone pain and kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with invasive breast cancer.

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My breast cancer is triple negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last day of study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last day of study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last day of study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group

Secondary outcome measures

Accrual Rate

Adherence Rate

Change in Fecal Microbiomes

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vitamin D Supplementation Group - Deficient LevelsExperimental Treatment3 Interventions

Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.

Group II: Observational Arm - Vitamin D at Normal LevelsActive Control1 Intervention

Standard of care neoadjuvant chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D3

2011

Completed Phase 4

~3590

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,217 Total Patients Enrolled

34 Trials studying Breast Cancer

5,047 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,855 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Emily H Douglas, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Standard of Care Neoadjuvant Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04677816 — Phase 2

Breast Cancer Clinical Trial 2023: Standard of Care Neoadjuvant Chemotherapy Highlights & Side Effects. Trial Name: NCT04677816 — Phase 2

Standard of Care Neoadjuvant Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677816 — Phase 2

Breast Cancer Research Study Groups: Vitamin D Supplementation Group - Deficient Levels, Observational Arm - Vitamin D at Normal Levels

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there reports of long-term side effects associated with Standard of Care Neoadjuvant Chemotherapy?

"Standard of Care Neoadjuvant Chemotherapy is thought to be safe based on phase 2 trial data, but there is no evidence at this time that the intervention is effective."

Answered by AI

How many individuals are included in this clinical trial?

"The listed information on clinicaltrials.gov suggests that this particular trial is still open to enrolling patients. This study was originally posted on 6/14/2021, with the most recent update being 2/8/2022. 50 participants are needed at a single location."

Answered by AI