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

NCT03566394 | Unknown Phase 2 FDA Drug

• 1 other identifier: Gabapentin RCT
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Invasive Breast Cancer; Chemotherapeutic Toxicity; Myalgia; Arthralgia

Outcome Measures

Primary Outcomes (1)

• "Worst" pain score

  Brief Pain Inventory-short form assessment tool

  Approximately 8 months

Secondary Outcomes (6)

• Arithmetic mean of the four severity pain score items

  Approximately 8 months

• Quality of life and function

  Approximately 8 months

• Chemotherapy dose reductions, delays, and discontinuation

  Approximately 8 months

• Incidence and severity of peripheral neuropathy

  Approximately 8 months

• Gabapentin-related adverse events

  Approximately 8 months

Study Arms (2)

Prophylactic Gabapentin

EXPERIMENTAL

Gabapentin at a dose of 300mg three times a day for 2 days before and 5 days after each taxane infusion. Administered orally.

Drug: Gabapentin 300mg

Observation

NO INTERVENTION

Interventions

Gabapentin 300mg DRUG

Gabapentin 300mg orally three times a day, from 2 days before to 5 days after taxane infusion

Prophylactic Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

MeSH Terms

Conditions

Myalgia; Arthralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: July 2, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share