Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer - Full Text View

Purpose

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer.

PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Dietary Supplement: fruit and vegetable extracts Dietary Supplement: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:

Expression of p27 cell cycle regulatory protein, associated with disease-free survival as measured by blood sample at baseline and week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cell proliferation (Ki-67), DNA damage (strand breaks), and immune function (T-cell function) as measured by biopsy at baseline and week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Tobacco and alcohol use as measured by head and neck baseline questionnaire and food frequency questionnaire at baseline and week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Depression as measured by Center for Epidemiologic Depression scale and positive symptom subscale at baseline and week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Serum carotenoids and antioxidant levels (vitamins A, C, and E) as measured by blood tests at baseline and week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	132
Study Start Date:	January 2004
Study Completion Date:	April 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral fruit and vegetable extracts twice daily.	Dietary Supplement: fruit and vegetable extracts Given orally
Placebo Comparator: Arm II Patients receive oral placebo twice daily.	Dietary Supplement: placebo Given orally

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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])

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064298

Show 28 Study Locations

Sponsors and Collaborators

Wake Forest Cancer Center CCOP Research Base

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven A. Akman, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:	NCT00064298 History of Changes
Other Study ID Numbers:	WFU-60A02, U10CA081851
Study First Received:	July 8, 2003
Last Updated:	April 3, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest Cancer Center CCOP Research Base:

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

Additional relevant MeSH terms:

Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013