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

Zeina Nahleh, MD

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).

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.

Vitamin B12 is to be taken sublingually on a daily basis for 90 days

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

The Brief Pain Inventory - Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine" We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours.

Analysis of the data collected at baseline and at the end of treatment in the BPI-SF questionnaire. The Brief Pain Inventory - Short Form (BPI- SF) worst pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Participants were asked to rate worst pain an average pain within the last 24 hours.

All of the items in this questionnaire have a 5 scale rating, from not at all (0) to very much (4). Outcomes were measured pre and post treatment. Version 4 of the FACT-ES contains 3 subscales with seven questions: Physical Well-Being (PWB) (score range 0-28), Functional Well-Being (FWB) (score range 0-28), and Social and Well-Being (SWB) (score range 0-28); Emotional Well-Being (EWB) (score range 0-24) with six questions, and the Endocrine Symptom Subscale (ESS) (score range 0-76) containing 19 questions. For all subscale a higher score represents better quality of life.

Inflammatory markers were measured pre and post treatment.

Texas Tech University Health Sciences Center, El Paso

Professor

Oral Vitamin B12

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

Arm I

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Five of 41 participants did not complete the study medications and were not analyzed

Zeina Nahleh, MD (previoulsy PI at Texas Tech university HSC-EP)

A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study.

Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF).

Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level \> or=4 using BPI-SF)

Percentage Change in Worst Pain at the End of Treatment .

This analysis is comparing EWB before and after treatment.

This analysis is comparing PWB before and after treatment.

This analysis is comparing FWB before and after treatment.

This analysis is comparing ESS before and after treatment.

postemneopausal women with ER + , Stages I-III breast cancer

Spots Global Cancer Trial Database for relief of joint pain