Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

NCT ID: NCT03069313

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-19
• Study Completion Date: 2016-10-27

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Oral Vitamin B12

Group Type: EXPERIMENTAL

Vitamin B12

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin B12

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Sign informed consent and Pain level > 4 in the BPI scale,
• Stage I-III

Exclusion Criteria

• <18 yrs
• Stage IV
• BPI Score <4
• Zubrod score >2

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Zeina Nahleh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeina Nahleh, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University HSC El Paso

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

E15122

Identifier Type: -

Identifier Source: org_study_id