Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027963
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2001-12-07
Brief Title:
Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy A Phase III Randomized Double-Blind Placebo-Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0196 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069098 | REGISTRY | None | None |
| NCCTG-CCC-0020 | None | None | None |