Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Taxane-induced arthralgia and myalgia syndrome (TAMS) is one of the most common side effects of taxane chemotherapy. This prospective randomized controlled trial will evaluate the efficacy of gabapentin administered prophylactically on days -2 to +5 during the taxane-portion of chemotherapy for adjuvant breast cancer patients on reducing TAMS. This will be compared to observation alone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Taxane

Criteria

Inclusion Criteria:

• English-speaking

• Patients must have histologically confirmed, Stage I-III, breast cancer

• Patient is on an 8-cycle adjuvant anthracycline-cyclophosphamide-taxane containing chemotherapy regimen, and will be starting the taxane-containing portion of chemotherapy within 4 weeks of enrollment.

• Patient has not received prior taxane chemotherapy

• ECOG performance status 0 to 2 (on a scale from 0 to 4, with 0 indicating normal activity, 1 symptomatic but ambulatory self-care possible, 2 ambulatory more than 50% of the time, 3 ambulatory 50% of the time or less and nursing care required, and 4 bedridden and possibly requiring hospitalization)

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients on FEC-D, ACTW, DCx4 chemotherapy.

• Metastatic disease

• Patient currently taking gabapentin or pregabalin for other indications prior to initiating chemotherapy

• Patients concomitantly taking other drugs known to influence GABA (e.g. barbituates, benzodiazepines, nonbenzodiazepines, baclofen)

• Patients using selected analgesics (opioids, acetaminophen, aspirin, NSAIDs) in which the dosages have changed in the 2 weeks prior to starting Taxane chemotherapy, or an analgesic medication was discontinued in the last 2 weeks, or a new analgesic medication was started in the last 2 weeks.

• Patients concomitantly using medical marijuana

• Known restricting adverse events or allergy to gabapentin or pregabalin supplements.

• GFR less than 30ml/min

• Myalgia and/or arthralgia unrelated to chemotherapy, or severe pain syndromes, that could confound the results.