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Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

NCT03069313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-02-01

Study results available
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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).

Conditions

  • Relief of Joint Pain

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

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

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center, El Paso

    lead OTHER

Principal Investigators

  • Zeina Nahleh, MD · Texas Tech University HSC El Paso

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-19
Primary Completion
2016-10-27
Completion
2016-10-27

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 NCT03069313 on ClinicalTrials.gov