Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

462

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2013

Study Completion Date

November 30, 2013

Conditions
NeurotoxicityPainPeripheral NeuropathyUnspecified Adult Solid Tumor, Protocol Specific
Interventions
DRUG

ketamine/amitriptyline NP-H cream

Subjects were instructed to apply up to, but not exceeding, 4 g of ketamine/amitriptyline NP-H cream two times per day to each area with pain, numbness, and/or tingling. A measuring device was provided to assist in dispensing the proper amount of the cream.

OTHER

placebo

Applied topically

Trial Locations (17)

11030

CCOP - North Shore University Hospital, Manhasset

13057

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse

29303

CCOP - Upstate Carolina, Spartanburg

29615

CCOP - Greenville, Greenville

49503

CCOP - Grand Rapids, Grand Rapids

54449

CCOP - Marshfield Clinic Research Foundation, Marshfield

55416

CCOP - Metro-Minnesota, Saint Louis Park

60201

CCOP - Evanston, Evanston

62526

CCOP - Central Illinois, Decatur

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

96813

MBCCOP - Hawaii, Honolulu

97225

CCOP - Columbia River Oncology Program, Portland

98101

CCOP - Virginia Mason Research Center, Seattle

60612-7323

MBCCOP - University of Illinois at Chicago, Chicago

67214-3882

CCOP - Wichita, Wichita

27104-4241

CCOP - Southeast Cancer Control Consortium, Winston-Salem

98405-0986

CCOP - Northwest, Tacoma

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Gary Morrow

OTHER

NCT00471445 - Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients | Biotech Hunter | Biotech Hunter