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

NCT ID: NCT00064298

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2009-04-01

Brief Summary

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm I - JuicePlus

Patients receive oral fruit and vegetable extracts twice daily.

Group Type: EXPERIMENTAL

fruit and vegetable extracts

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Arm II - Control

Patients receive oral placebo twice daily.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Interventions

fruit and vegetable extracts

Given orally

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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])

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven A. Akman, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Redwood Regional Medical Group

Santa Rosa, California, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

MBCCOP - JHS Hospital of Cook County

Chicago, Illinois, United States

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

CCOP - Beaumont

Royal Oak, Michigan, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Missouri Baptist Cancer Center

St Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, United States

Hugh Chatham Memorial Hospital

Elkin, North Carolina, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, United States

High Point Regional Hospital

High Point, North Carolina, United States

Caldwell Memorial Hospital

Lenoir, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Danville Regional Medical Center

Danville, Virginia, United States

Countries

United States

References

Datta M, Shaw EG, Lesser GJ, Case LD, Vitolins MZ, Schneider C, Frizzell B, Sullivan C, Lively M, Franzmann E, Hu JJ. A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer. Integr Cancer Ther. 2018 Mar;17(1):115-123. doi: 10.1177/1534735416684947. Epub 2017 Jan 19.

Reference Type: DERIVED

PMID: 28102098 (View on PubMed)

Other Identifiers

U10CA081851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REBAWFU-60A02

Identifier Type: -

Identifier Source: org_study_id