Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00027963
First received: December 7, 2001
Last updated: July 30, 2015
Last verified: July 2015
  Purpose

RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.


Condition Intervention Phase
Neurotoxicity
Pain
Drug: gabapentin
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Change in pain and symptoms [ Time Frame: Up to 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Up to 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2002
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gabapentin

Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8.

Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.

Drug: gabapentin
Placebo Comparator: placebo

Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8.

Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.

Other: placebo

Detailed Description:

OBJECTIVES:

  • Determine whether gabapentin improves the pain and other symptoms in cancer patients with chemotherapy-induced peripheral neuropathy.
  • Determine the effect of this drug on symptom distress, mood states, functional abilities, and overall quality of life in these patients.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to neurotoxic chemotherapy (active vs nonactive and discontinued vs completed) and neurotoxic chemotherapeutic agents (vinca alkaloids vs taxanes vs platinum-based compounds vs combination of two or more of the above agents). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8.
  • Arm II: Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8.

Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Has received or is currently receiving neurotoxic chemotherapy, including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin), or vinca alkaloids (e.g., vincristine or vinblastine)
  • Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy

    • Average daily pain rating of at least 4 out of 10 using the pain numerical rating scale (where 0 is no pain and 10 is the worst pain possible) OR
    • Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common

      • Toxicity Criteria for sensory neuropathy
  • No other identified causes of painful paresthesia existing prior to chemotherapy

    • No radiotherapy-induced or malignant plexopathy
    • No lumbar or cervical radiculopathy
    • No pre-existing peripheral neuropathy of another etiology, including:

      • B12 deficiency
      • AIDS
      • Monoclonal gammopathy
      • Diabetes
      • Heavy metal poisoning
      • Amyloidosis
      • Syphilis
      • Hyperthyroidism or hypothyroidism
      • Inherited neuropathy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Life expectancy:

  • At least 6 months

Renal:

  • Creatinine no greater than 1.5 times upper limit of normal

Other:

  • No prior allergic reaction or intolerance to gabapentin
  • No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study compliance
  • No extreme difficulty swallowing pills
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Other:

  • More than 30 days since prior investigational agent for pain control
  • Concurrent selective serotonin reuptake inhibitors allowed
  • Concurrent nonsteroidal anti-inflammatory drugs allowed
  • No concurrent tricyclic antidepressant (e.g., amitriptyline, nortriptyline, or desipramine)*
  • No concurrent monoamine oxidase inhibitor*
  • No concurrent opioid analgesic*
  • No other concurrent adjuvant analgesic (e.g., anticonvulsant, clonazepam, or mexiletine)*
  • No concurrent topical analgesics (e.g., lidocaine gel or lidocaine patch)*
  • No concurrent amifostine
  • No concurrent investigational agent for pain control NOTE: * For pain or symptoms due to chemotherapy-induced peripheral neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027963

  Show 23 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00027963     History of Changes
Other Study ID Numbers: NCCTG-N00C3, CDR0000069098, NCCTG-CCC-0020, NCI-P01-0196
Study First Received: December 7, 2001
Last Updated: July 30, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
neurotoxicity
pain

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Chemically-Induced Disorders
Nervous System Diseases
Neuromuscular Diseases
Poisoning
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on August 03, 2015