Relief of Joint Pain Clinical Trial
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
| Verified date | January 2018 |
| Source | Texas Tech University Health Sciences Center, El Paso |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | October 27, 2016 |
| Est. primary completion date | October 27, 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Texas Tech University Health Sciences Center, El Paso |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Percentage Change in Worst Pain at the End of Treatment . | 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. | Baseline and 90 days (+/- 10 days) | |
| Secondary | Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) | 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. | Baseline and 90 days (+/- 10 days) | |
| Secondary | Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA). | Inflammatory markers were measured pre and post treatment. | Baseline and at 90 days (+/- 10 days) |