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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064298
• Other study ID #: REBAWFU-60A02
• Secondary ID: U10CA081851
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2004
• Est. completion date: April 1, 2009

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 1, 2009
• Est. primary completion date: October 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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])

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• fruit and vegetable extracts
Given orally
• placebo
Given orally

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois
United States	Danville Regional Medical Center	Danville	Virginia
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Hugh Chatham Memorial Hospital	Elkin	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South 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	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Redwood Regional Medical Group	Santa Rosa	California
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	MBCCOP - Howard University Cancer Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12	Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.	baseline and 12 weeks
Secondary	Cell Proliferation (Ki-67) at Baseline and Week 12	Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.	baseline and 12 weeks

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database