Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471445
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2007-05-08
Brief Title:
Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Assessment of Topical Treatment Response With Amitriptyline and Ketamine Combination Trial in Chemotherapy Peripheral Neuropathy ATTRACT-CPN
Status:
COMPLETED
Status Verified Date:
2015-10
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 Topical cream containing amitriptyline and ketamine may help relieve pain numbness tingling and other symptoms of peripheral neuropathy It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy
PURPOSE This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer
PURPOSE This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer
Detailed Description:
OBJECTIVES
Compare the analgesic properties and safety of topical amitriptyline and ketamine hydrochloride cream vs placebo in cancer patients with chemotherapy peripheral neuropathy CPN who have received taxanes or other cancer chemotherapy agents
OUTLINE This is a multicenter double-blind randomized placebo-controlled study Patients are stratified according to Community Clinical Oncology Program CCOP site Patients are randomized to 1 of 2 treatment arms
Arm I Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain numbness or tingling in the hands andor feet
Arm II Patients apply a placebo cream twice daily to areas of pain numbness or tingling in the hands andor feet
In both arms treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity Patients may continue treatment for up to a total of 12 weeks
Patients complete a peripheral neuropathy intensity and quality of sleep diary daily Patients also complete the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy EORTC-CIPN20 to assess change in sensory score and the Brief Pain Inventory and Hospital Anxiety and Depression Scale to assess health-related quality of life in week 3 and 6 The Vulnerable Elders Survey VES-13 is administered at baseline to assess level of physical activity and the University of Rochester Cancer Center URCC symptom inventory is administered to track other potentially important symptoms The Patient Global Impression of Change Questionnaire is administered in week 6 to assess the patients overall assessment of change since beginning treatment including changes in pain side effects functional status and overall satisfaction with treatment
PROJECTED ACCRUAL A total of 462 patients will be accrued for this study
Compare the analgesic properties and safety of topical amitriptyline and ketamine hydrochloride cream vs placebo in cancer patients with chemotherapy peripheral neuropathy CPN who have received taxanes or other cancer chemotherapy agents
OUTLINE This is a multicenter double-blind randomized placebo-controlled study Patients are stratified according to Community Clinical Oncology Program CCOP site Patients are randomized to 1 of 2 treatment arms
Arm I Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain numbness or tingling in the hands andor feet
Arm II Patients apply a placebo cream twice daily to areas of pain numbness or tingling in the hands andor feet
In both arms treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity Patients may continue treatment for up to a total of 12 weeks
Patients complete a peripheral neuropathy intensity and quality of sleep diary daily Patients also complete the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy EORTC-CIPN20 to assess change in sensory score and the Brief Pain Inventory and Hospital Anxiety and Depression Scale to assess health-related quality of life in week 3 and 6 The Vulnerable Elders Survey VES-13 is administered at baseline to assess level of physical activity and the University of Rochester Cancer Center URCC symptom inventory is administered to track other potentially important symptoms The Patient Global Impression of Change Questionnaire is administered in week 6 to assess the patients overall assessment of change since beginning treatment including changes in pain side effects functional status and overall satisfaction with treatment
PROJECTED ACCRUAL A total of 462 patients 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 |
|---|---|---|---|
| U10CA037420 | NIH | None | None |
| URCC-0605 | OTHER | None | None |
| URCC07004 | OTHER | University of Rochester | httpsreporternihgovquickSearchU10CA037420 |