N/A
Completed N=41
Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms
Relief of Joint Pain
Source: ClinicalTrials.gov NCT03069313 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: 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). — -33.8 Percentage change — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
-33.8 | <0.0001 sig |
| SECONDARY Percentage Change in Worst Pain at the End of Treatment . |
-23.03 | 0.0003 sig |
| SECONDARY Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) |
10.02; 10.8; 46.3; 18; 15.6 | 0.133 |
| SECONDARY Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA). |
209.8; 64.2; -24.6; -7.1 | — |
Eligibility Criteria
Inclusion Criteria
- Sign informed consent and Pain level > 4 in the BPI scale,
- Stage I-III
Exclusion Criteria
- 2
Data sourced from ClinicalTrials.gov (NCT03069313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.