Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

• ClinicalTrials.gov Identifier: NCT03069313
• Recruitment Status: Completed
• First Posted: March 3, 2017
• Results First Posted: February 1, 2018
• Last Update Posted: February 1, 2018
• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Information provided by (Responsible Party): Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Relief of Joint Pain	Dietary Supplement: Vitamin B12	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Vitamin B12 is to be taken sublingually on a daily basis for 90 days
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 19, 2015
• Actual Primary Completion Date: October 27, 2016
• Actual Study Completion Date: October 27, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm I; Oral Vitamin B12	Dietary Supplement: Vitamin B12; Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)

Outcome Measures

Primary Outcome Measures :

1. 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). [ Time Frame: Baseline and 90 days (+/- 10 days) ]
   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.

Secondary Outcome Measures :

1. Percentage Change in Worst Pain at the End of Treatment . [ Time Frame: Baseline and 90 days (+/- 10 days) ]
   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.
2. Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) [ Time Frame: Baseline and 90 days (+/- 10 days) ]
   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.
3. Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA). [ Time Frame: Baseline and at 90 days (+/- 10 days) ]
   Inflammatory markers were measured pre and post treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Breast cancer patients
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Texas Tech University Health Sciences Center, El Paso

Investigators

• Principal Investigator: Zeina Nahleh, MD; Texas Tech University HSC El Paso

  Study Documents (Full-Text)

Documents provided by Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso:

Study Protocol and Statistical Analysis Plan  [PDF] February 19, 2016

More Information

• Responsible Party: Zeina Nahleh, Professor, Texas Tech University Health Sciences Center, El Paso
• ClinicalTrials.gov Identifier: NCT03069313
• Other Study ID Numbers: E15122
• First Posted: March 3, 2017
• Results First Posted: February 1, 2018
• Last Update Posted: February 1, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso:

Aromatase Inhibitor; Breast Cancer; Arthralgia; Musculoskeletal symptoms; Joint pain

Additional relevant MeSH terms:

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Vitamin B 12; Hydroxocobalamin; Vitamins; Micronutrients; Physiological Effects of Drugs; Vitamin B Complex; Hematinics