Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

NCT03069313 | Completed Results DMC

• 1 other identifier: E15122
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Relief of Joint Pain

Keywords

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

Outcome Measures

Primary Outcomes (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).

  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.

  Baseline and 90 days (+/- 10 days)

Secondary Outcomes (3)

• Percentage Change in Worst Pain at the End of Treatment .

  Baseline and 90 days (+/- 10 days)

• Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)

  Baseline and 90 days (+/- 10 days)

• Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).

  Baseline and at 90 days (+/- 10 days)

Study Arms (1)

Arm I

EXPERIMENTAL

Oral Vitamin B12

Dietary Supplement: Vitamin B12

Interventions

Vitamin B12 DIETARY_SUPPLEMENT

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

Arm I

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Zeina Nahleh, MD (previoulsy PI at Texas Tech university HSC-EP)
• Organization: Cleveland Clinic Florida

nahlehz@ccf.org

9546595840

Study Officials

• Zeina Nahleh, MD

  Texas Tech University HSC El Paso

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 3, 2017
• Study Start: October 19, 2015
• Primary Completion: October 27, 2016
• Study Completion: October 27, 2016
• Last Updated: February 1, 2018
• Results First Posted: February 1, 2018

Record last verified: 2018-01