Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer

Phase 3

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Neurotoxicity

Interventions: Other: placebo
Dietary Supplement: vitamin E

Registration Number: NCT00363129

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary: RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients with cancer. It is not yet known whether vitamin E is more effective than a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.

Detailed Description: OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (taxane vs cisplatin vs carboplatin vs oxaliplatin vs combination), age (≤ 50 years vs \> 50 years), and gender. Patients are randomized to 1 of 2 treatment arms.

OBJECTIVES:

Primary

* Compare the incidence of chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 in patients undergoing curative neurotoxic chemotherapy for cancer treated with vitamin E vs placebo.

Secondary

* Compare the proportion of patients requiring dose reductions of chemotherapy secondary to sensory peripheral neuropathy.

* Compare the proportion of patients stopping chemotherapy before treatment is complete secondary to sensory peripheral neuropathy.

* Assess the toxicity of vitamin E in these patients.

After completion of study treatment, patients are followed at 6 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Arm I	vitamin E	Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy	6 months post completion of chemotherapy treatment
Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.
Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy	6 months post completion of chemotherapy treatment
Duration of Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.

Trial Locations

Locations (69): Graham Hospital
🇺🇸
Canton, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Memorial Hospital
🇺🇸
Carthage, Illinois, United States
Mason District Hospital
🇺🇸
Havana, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸
Sioux City, Iowa, United States
Bismarck Cancer Center
🇺🇸
Bismarck, North Dakota, United States
Medcenter One Hospital Cancer Care Center
🇺🇸
Bismarck, North Dakota, United States
Doctors Hospital at Ohio Health
🇺🇸
Columbus, Ohio, United States
St. Joseph Medical Center
🇺🇸
Bloomington, Illinois, United States
Galesburg Clinic, PC
🇺🇸
Galesburg, Illinois, United States
Eureka Community Hospital
🇺🇸
Eureka, Illinois, United States
Galesburg Cottage Hospital
🇺🇸
Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸
Hopedale, Illinois, United States
Kewanee Hospital
🇺🇸
Kewanee, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸
Joliet, Illinois, United States
BroMenn Regional Medical Center
🇺🇸
Normal, Illinois, United States
Community Cancer Center
🇺🇸
Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸
Peoria, Illinois, United States
Community Hospital of Ottawa
🇺🇸
Ottawa, Illinois, United States
Perry Memorial Hospital
🇺🇸
Princeton, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸
Michigan City, Indiana, United States
St. Luke's Regional Medical Center
🇺🇸
Sioux City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸
Ottumwa, Iowa, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸
Dearborn, Michigan, United States
Foote Memorial Hospital
🇺🇸
Jackson, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸
Grosse Pointe Woods, Michigan, United States
St. John Macomb Hospital
🇺🇸
Warren, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸
Lansing, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸
Saginaw, Michigan, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸
Fridley, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸
Coon Rapids, Minnesota, United States
Fairview Ridges Hospital
🇺🇸
Burnsville, Minnesota, United States
Fairview Southdale Hospital
🇺🇸
Edina, Minnesota, United States
Hutchinson Area Health Care
🇺🇸
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸
Lichfield, Minnesota, United States
Immanuel St. Joseph's
🇺🇸
Mankato, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸
Maplewood, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸
Maplewood, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸
St Paul, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸
Woodbury, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸
Woodbury, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸
Shakopee, Minnesota, United States
United Hospital
🇺🇸
St. Paul, Minnesota, United States
Mid Dakota Clinic, PC
🇺🇸
Bismarck, North Dakota, United States
Riverside Methodist Hospital Cancer Care
🇺🇸
Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸
Chillicothe, Ohio, United States
CCOP - Columbus
🇺🇸
Columbus, Ohio, United States
Grant Riverside Cancer Services
🇺🇸
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸
Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸
Delaware, Ohio, United States
Mercy Medical Center
🇺🇸
Springfield, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸
Newark, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸
Springfield, Ohio, United States
Fairfield Medical Center
🇺🇸
Lancaster, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸
Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸
Zanesville, Ohio, United States
Avera Cancer Institute
🇺🇸
Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
🇺🇸
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸
Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸
Saint Louis Park, Minnesota, United States
Saint Joseph Mercy Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸
Ann Arbor, Michigan, United States