Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

Texas Tech University Health Sciences Center, El Paso

Status: Completed

Conditions: Relief of Joint Pain

Treatments: Dietary Supplement: Vitamin B12

Study type: Interventional

Funder types: Other

Identifiers

NCT03069313

E15122

Details and patient eligibility

About

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).

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Arm I

Experimental group

Description:

Oral Vitamin B12

Treatment:

Dietary Supplement: Vitamin B12