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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 AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
United HospitalSt. Paul, Minnesota  55102
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
CCOP - ColumbusColumbus, Ohio  43206
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Perry Memorial HospitalPrinceton, Illinois  61356
Bismarck Cancer CenterBismarck, North Dakota  58501
Mercy Medical CenterSpringfield, Ohio  45504
Foote Memorial HospitalJackson, Michigan  49201
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Galesburg Clinic, PCGalesburg, Illinois  61401
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
Immanuel St. Joseph'sMankato, Minnesota  56002