MedTrace Logo

Vitamin B12 for Aromatase Inhibitors Associated Musculoskeletal Symptoms in Breast Cancer

NCT04205786 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-21

No results posted yet for this study

Summary

Treatment of hormone receptor (HR)-positive breast cancer with Aromatase Inhibitors (AIs) can lead to associated musculoskeletal pain and may cause patients to discontinue important treatment.

This is a randomized controlled trial assessing the affect of Vitamin B12 on AI-associated joint pain and other outcomes. Participants will be randomly assigned 1:1 to treatment or control arm.

The primary objective of this study is:

-To assess whether daily oral Vitamin B12 decreases average joint pain in women with AI-Associated Musculoskeletal Symptoms

Secondary objectives include:

* To investigate whether daily vitamin B12 improves functional quality of life
* To explore the impact of treatment on serum inflammatory cytokine levels (C- reactive protein) between baseline and various points in treatment.

Conditions

  • HR-positive Breast Cancer

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

Vitamin B12, orally, 2500 mcg, daily, for 90 days

OTHER

Blood collection

Blood collection for laboratory testing will occur within 10 days of signing the consent form, on day 45 +/- 10 days, and on day 90 +/- 10 days. It will include: 1. Serum B12 levels 2. CRP 3. Homocysteine level 4. MMA

OTHER

Brief Pain Inventory - Short Form survey

Brief Pain Inventory - Short Form survey

OTHER

FACT-ES Trial Outcome Index (Version 4)

FACT-ES Trial Outcome Index (Version 4)

OTHER

Questionnaire to Assess Adherence to Aromatase Inhibitors

Questionnaire to Assess Adherence to Aromatase Inhibitors

OTHER

Demographics Questionnaire

Demographics Questionnaire

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Zeina Nahleh, MD · Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2024-12-01
Completion
2025-12-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205786 on ClinicalTrials.gov