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

Primary Purpose

Invasive Breast Cancer, Chemotherapeutic Toxicity, Myalgia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gabapentin 300mg
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Prophylactic Gabapentin

    Observation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    "Worst" pain score
    Brief Pain Inventory-short form assessment tool

    Secondary Outcome Measures

    Arithmetic mean of the four severity pain score items
    Brief Pain Inventory-short form assessment tool
    Quality of life and function
    FACT-Taxane Scale
    Chemotherapy dose reductions, delays, and discontinuation
    Incidence and severity of peripheral neuropathy
    EORTC-QLQ-CIPN20
    Gabapentin-related adverse events
    Opioid initiation or modifications

    Full Information

    First Posted
    June 12, 2018
    Last Updated
    June 12, 2018
    Sponsor
    British Columbia Cancer Agency
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03566394
    Brief Title
    Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy
    Official Title
    Primary Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2, 2018 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    British Columbia Cancer Agency

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.
    Detailed Description
    The taxanes are a class of anticancer agents that interfere with microtubule disassembly. They have been an integral part of adjuvant breast cancer treatment since the early 2000s. Taxane-induced arthralgia and myalgia syndrome (TAMS) is one of the most common side effects of taxane chemotherapy. It is characterized by muscle and joint pain that often starts 24-48 hours after taxane-based chemotherapy, and lasts for 5-7 days. TAMS can significantly impact the level of functioning and quality of life of early-stage breast cancer patients and can occur in up to 87% of women during their chemotherapy. Many studies have been conducted looking at medications to prevent TAMS. Unfortunately, these are primarily small retrospective or case series studies, and no standard of care has been established. Results from studies looking at antihistamines, corticosteroids, opioids, amifostine, glutamine, Shakuyaku-Kanzou-to (a Japanese herbal medicine), are conflicting and/or inconclusive. Gabapentin, a structural analog of gamma amino butyric acid (GABA), is a second-line antiepileptic and is also widely used to treat neuropathic pain syndromes. Many oncologists already use prophylactic gabapentin in an attempt to prevent TAMS, however this is supported primarily by small case series and retrospective data, and is not considered standard of care. Unfortunately, a systemic review found no randomized controlled trial evidence supporting these findings. This prospective randomized controlled trial will be conducted to 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. The hypothesis for this study is that prophylactic gabapentin is more effective than observation in reducing the severity of taxane-induced arthralgias and myalgias syndrome in breast cancer patients undergoing adjuvant chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Invasive Breast Cancer, Chemotherapeutic Toxicity, Myalgia, Arthralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prophylactic Gabapentin
    Arm Type
    Experimental
    Arm Description
    Gabapentin at a dose of 300mg three times a day for 2 days before and 5 days after each taxane infusion. Administered orally.
    Arm Title
    Observation
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin 300mg
    Intervention Description
    Gabapentin 300mg orally three times a day, from 2 days before to 5 days after taxane infusion
    Primary Outcome Measure Information:
    Title
    "Worst" pain score
    Description
    Brief Pain Inventory-short form assessment tool
    Time Frame
    Approximately 8 months
    Secondary Outcome Measure Information:
    Title
    Arithmetic mean of the four severity pain score items
    Description
    Brief Pain Inventory-short form assessment tool
    Time Frame
    Approximately 8 months
    Title
    Quality of life and function
    Description
    FACT-Taxane Scale
    Time Frame
    Approximately 8 months
    Title
    Chemotherapy dose reductions, delays, and discontinuation
    Time Frame
    Approximately 8 months
    Title
    Incidence and severity of peripheral neuropathy
    Description
    EORTC-QLQ-CIPN20
    Time Frame
    Approximately 8 months
    Title
    Gabapentin-related adverse events
    Time Frame
    Approximately 8 months
    Title
    Opioid initiation or modifications
    Time Frame
    Approximately 8 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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