Clinical trial NCT03069313: Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relief of Joint Pain
Keywords: Aromatase Inhibitor
Breast Cancer
Arthralgia
Musculoskeletal symptoms
Joint pain
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Vitamin B12 is to be taken sublingually on a daily basis for 90 days
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: Baseline and 90 days (+/- 10 days)
Secondary outcomes:
measure: Percentage Change in Worst Pain at the End of Treatment .
timeFrame: Baseline and 90 days (+/- 10 days)
measure: Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
timeFrame: Baseline and 90 days (+/- 10 days)
measure: Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
timeFrame: Baseline and at 90 days (+/- 10 days)
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University HSC El Paso
name: Zeina Nahleh, MD
role: PRINCIPAL_INVESTIGATOR
References: