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The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study


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.

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.

- Arm I: 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.

- Arm II: 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.

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

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Scheduled to undergo curative-intent adjuvant neurotoxic chemotherapy for cancer

- Regimen must include ≥ 1 of the following neurotoxic chemotherapeutic agents:

- Taxanes (e.g., paclitaxel or docetaxel)

- Platinum compounds (e.g., cisplatin, carboplatin, or oxaliplatin*) NOTE:
*Patients receiving oxaliplatin should preferentially be enrolled in
protocol NCCTG-N04C7

- No preexisting or history of peripheral neuropathy due to any cause (e.g., diabetes,
alcohol, toxin, or hereditary)

- Must have resected tumor with or without microscopic residual disease or residual
margin involvement

- No head and neck cancers

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- Able to complete questionnaire(s) alone or with assistance

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of coronary artery disease, including, any of the following:

- Myocardial infarction within the past 5 years

- Percutaneous transluminal coronary angioplasty within the past 5 years

- Coronary artery bypass graft within the past 5 years

- New York Heart Association class I-IV congestive heart failure

- No other medical conditions that would contraindicate study therapy

- No history of hemorrhagic stroke

- No diabetes requiring insulin or oral hypoglycemic medications

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior valve replacement surgery allowed provided patient has fully recovered from the
surgery

- No prior neurotoxic chemotherapy unless the following criteria are met:

- Patient has started neurotoxic chemotherapy within 4 days of starting vitamin E
on this study

- Patient has not been previously treated with other neurotoxic chemotherapy
agents

- No vitamin E supplementation within 7 days prior to randomization (except for 1
multivitamin per day that contains ≤ 100 mg of vitamin E)

- No concurrent neoadjuvant therapy

- No concurrent chemotherapy for palliative care

- No concurrent regular opioid-containing medications

- Opioids for short-term treatment of chemotherapy-induced myalgias or arthralgias
caused by taxanes allowed

- No concurrent anticonvulsants, tricyclic antidepressants, or other neuropathic pain
medications (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine,
topical lidocaine patch, or capsaicin cream)

- No concurrent anticoagulant medication (e.g., warfarin, low molecular weight heparin,
or platelet-aggregation inhibitors, such as clopidgrel or acetylsalicylic acid)

- 1 mg/day of warfarin for central line maintenance is allowed

- No planned concurrent radiotherapy

- No other concurrent therapy for chemotherapy-induced peripheral neuropathy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Percentage of patients with chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 as measured by NCI CTCAE v3.0

Safety Issue:

Yes

Principal Investigator

Lisa Kottschade, RN, MSN, CNP

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000491071

NCT ID:

NCT00363129

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • neurotoxicity
  • unspecified adult solid tumor, protocol specific
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes

Name

Location

CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
United Hospital St. Paul, Minnesota  55102
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
CCOP - Columbus Columbus, Ohio  43206
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Mount Carmel Health - West Hospital Columbus, Ohio  43222
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
Perry Memorial Hospital Princeton, Illinois  61356
Bismarck Cancer Center Bismarck, North Dakota  58501
Mercy Medical Center Springfield, Ohio  45504
Foote Memorial Hospital Jackson, Michigan  49201
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Galesburg Clinic, PC Galesburg, Illinois  61401
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
Immanuel St. Joseph's Mankato, Minnesota  56002