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A Randomized Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors (AI)-Associated Musculoskeletal Symptoms (AIMSS) in Women With Early Stage Breast Cancer
Sponsor study identifier
interventional
0
1 country
1
Study Start
August 12, 2021
Actual (reported)Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2019
Actual (reported)December 19, 2019
Actual (reported)August 12, 2021
Actual (reported)December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in average joint pain according to the Brief Pain Inventory - Short Form (BPI- SF)
Change in average joint pain according to the Brief Pain Inventory - Short Form (BPI- SF) average pain score. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine"
At baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
Change in worst joint pain according to the BPI-SF
At day 90 (+/- 10 days)
Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
At baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
Serum inflammatory cytokine levels (C- reactive protein)
At baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
Day 0: * Baseline questionnaires: FACT-ES, BPI-SF, Assessment of AI Adherence, Demographics, CRF, and Supplemental Agents Reporting Form * Blood collection * Continue Usual Care Day 45: * Repeat of baseline questionnaires with addition of vitamin B12 supplements form and investigational agent accountability record * Blood collection * Continue Usual Care Day 90: -Repeat of day 45
Day 0: * Baseline questionnaires: FACT-ES, BPI-SF, Assessment of AI Adherence, Demographics, CRF, and Supplemental Agents Reporting Form * Blood collection * Oral intake of Vitamin B12 Daily in the morning Day 45 * Repeat of baseline questionnaires with addition of investigational agent accountability record * Blood collection * Oral intake of Vitamin B12 Daily in the morning Day 90: -Repeat of day 45 without additional study drug intake.
Vitamin B12, orally, 2500 mcg, daily, for 90 days
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
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Zeina Nahleh, MD
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
0 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2019
First Posted
December 19, 2019
Study Start
August 12, 2021
Actual (reported)Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms
Brief Pain Inventory - Short Form survey
FACT-ES Trial Outcome Index (Version 4)
Questionnaire to Assess Adherence to Aromatase Inhibitors
Demographics Questionnaire
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2024
Record last verified: 2024-08
Manuscripts, presentations, abstracts
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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