Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

Pain Clinical Trial

Official title:

The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027963
• Other study ID #: NCCTG-N00C3
• Secondary ID: CDR0000069098NCC
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2001
• Last updated: July 1, 2016
• Start date: February 2002
• Est. completion date: November 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neurotoxicity
• Neurotoxicity Syndromes
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• gabapentin

Other:
• placebo

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomize — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain and symptoms		Up to 14 weeks	No
Secondary	Quality of life		Up to 14 weeks	No