Clinical trial · Interventional
Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy
Primary Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Myalgia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin 300mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic Gabapentin
- description
- Gabapentin at a dose of 300mg three times a day for 2 days before and 5 days after each taxane infusion. Administered orally.
- interventionNames
- Drug: Gabapentin 300mg
- type
- NO_INTERVENTION
- label
- Observation
Primary outcomes (1)
- measure
- "Worst" pain score
- timeFrame
- Approximately 8 months
- description
- Brief Pain Inventory-short form assessment tool
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available