CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Vitamin B12dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03069313
NCT03069313N/ACompleted

A Single Arm Phase II Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors (AI) Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

Texas Tech University Health Sciences Center, El Paso·interventional·Posted Mar 3, 2017·Updated Feb 1, 2018

In Brief

A clinical study evaluating Vitamin B12 for Relief of Joint Pain. Completed, enrolled 41 participants.

Detailed Summary

Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with breast cancer leading to early discontinuation of this life-saving cancer treatment. No effective pharmacologic therapy has yet been identified for management of these symptoms, as many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis. This effect has not been studied in the setting of Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartOct 19, 2015
Primary CompletionOct 27, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.3 years ago

Interventions

Vitamin B12dietary

Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)