NCT03069313

Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Primary Objectives: a. To assess whether daily oral Vitamin B12 decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), as measured at baseline, 6 weeks and at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF). Secondary Objectives: 1. To investigate whether daily vitamin B12 improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES); 2. To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks.

Conditions

• Relief of Joint Pain

Interventions

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

Timeline

• Start date: 2015-10-19
• Primary completion: 2016-10-27
• Completion: 2016-10-27
• First posted: 2017-03-03
• Last updated: 2018-02-01
• Results posted: 2018-02-01