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Single arm phase II study of oral vitamin B12 for the treatment of musculoskeletal symptoms associated with aromatase inhibitors in women with early stage breast cancer

Plain-language guide to PMID 29442401 (2018): clinical trial, phase ii study of Cyanocobalamin (Vitamin B12).

Key Facts

PMID
29442401
Journal
The breast journal
Year
2018
Study type
Clinical Trial, Phase II
Authors
Campbell A et al. (5 authors)
DOI
10.1111/tbj.12951

What This Study Did, in Plain Language

What Was Tested

This clinical trial, phase ii paper looks at Cyanocobalamin (Vitamin B12).

The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal symptoms such as pain and arthralgias induced by AIs and to correlate response with serum and inflammatory biomarkers.

Why It Was Studied

Breast cancer patients receiving endocrine therapy with aromatase Inhibitors (AIs) often experience musculoskeletal and joint-related side effects.

Assessments at baseline and at 3 months included: BPI-SF pain scores, the impact on quality of life determined by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), and correlative serum markers relative to baseline (a pre-post study).

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults and older adults, women only.

Upon receiving approval by the Institutional Review Board (IRB), the majority of the patients consented into the study were treated at the Texas Tech Breast Care Center.

Only patients with an average pain score ≥ 4, as assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, were included in the study.

How the Study Was Run

A total of forty-one patients were enrolled.

What Was Measured

Assessments at baseline and at 3 months included: BPI-SF pain scores, the impact on quality of life determined by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), and correlative serum markers relative to baseline (a pre-post study).

PubMed files the paper under topics including Aromatase Inhibitors, Biomarkers, Breast Neoplasms, Musculoskeletal Diseases, Pain, Quality of Life and Vitamin B 12.

Author keywords: arthralgia, breast cancer, joint pain and vitamin B12.

What This Means in Plain Language

This is a phase 2 clinical trial of Cyanocobalamin (Vitamin B12).

The publication is from 2018 (The breast journal), a journal based in United States.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.

Our Notes on the Compound

Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.