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A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients


OBJECTIVES:

- Compare the disease-free survival of patients with stage I-IV (including stage IVA and
IVB) head and neck cancer treated with fruit and vegetable extracts vs placebo.

- Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation
of Ki-67, DNA damage, and T-cell function) in these patients.

- Correlate changes in biomarkers with other factors (e.g., site and stage of the
original tumors, tobacco/alcohol use, or depression) in patients treated with these
extracts.

- Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and
posttreatment in patients treated with these extracts.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are
stratified according to tobacco use (yes vs no), alcohol consumption (yes vs no), and tumor
stage at diagnosis (I vs II vs III vs IVA vs IVB). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral fruit and vegetable extracts twice daily.

- Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for
12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Curatively treated stage I-IV (including stage IVA and IVB) squamous cell carcinoma
of the upper aerodigestive tract of 1 of the following primary sites:

- Oral cavity

- Oropharynx

- Hypopharynx

- Larynx

- Disease-free for at least 6 months and no more than 3 years after completion of
surgery, radiotherapy, and/or chemotherapy

- No synchronous tumors

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100% OR

- Zubrod 0-1

Life expectancy

- At least 6 months

Hematopoietic

- Hemoglobin ≥ 10 g/dL

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 mg/dL

- SGOT ≤ 40 U/L

- SGPT ≤ 56 U/L

Renal

- Creatinine ≤ 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except curatively treated head and neck
squamous cell carcinoma, nonmelanoma skin cancer, or carcinoma in situ of the cervix

- No other serious medical or psychiatric illness that would preclude giving informed
consent

- No nausea ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- More than 6 months and less than 3 years since prior chemotherapy

- No concurrent chemotherapy

- No other concurrent chemopreventive agents

Endocrine therapy

- More than 6 months and less than 3 years since prior hormonal therapy

Radiotherapy

- See Disease Characteristics

- More than 6 months and less than 3 years since prior radiotherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- More than 6 months and less than 3 years since prior surgery

- No concurrent surgery

Other

- More than 6 months and less than 3 years since prior investigational agents

- More than 2 months since prior high-dose vitamins (i.e., 10 times the recommended
daily allowance [8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of
vitamin E])

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Expression of p27 cell cycle regulatory protein, associated with disease-free survival as measured by blood sample at baseline and week 12

Outcome Time Frame:

baseline and 12 weeks

Safety Issue:

No

Principal Investigator

Steven A. Akman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

WFU-60A02

NCT ID:

NCT00064298

Start Date:

January 2004

Completion Date:

April 2009

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Danville Regional Medical CenterDanville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
High Point Regional HospitalHigh Point, North Carolina  27261
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Redwood Regional Medical GroupSanta Rosa, California  95403
MBCCOP - JHS Hospital of Cook CountyChicago, Illinois  60612
Hugh Chatham Memorial HospitalElkin, North Carolina  28621
Caldwell Memorial HospitalLenoir, North Carolina  28645