NCT00064298 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-09-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12

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outcome · POSTED

Cell Proliferation (Ki-67) at Baseline and Week 12

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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 \[8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E\])
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral fruit and vegetable extracts twice daily.
intervention Names
Dietary Supplement: fruit and vegetable extracts
label
Arm I - JuicePlus
type
EXPERIMENTAL
description
Patients receive oral placebo twice daily.
intervention Names
Dietary Supplement: placebo
label
Arm II - Control
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I - JuicePlus
description
Given orally
name
fruit and vegetable extracts
type
DIETARY_SUPPLEMENT
arm Group Labels
Arm II - Control
description
Given orally
name
placebo
type
DIETARY_SUPPLEMENT

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

PREVENTION

Enrollment

count: 134
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
measure
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
time Frame
baseline and 12 weeks

secondary Outcomes

description
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.
measure
Cell Proliferation (Ki-67) at Baseline and Week 12
time Frame
baseline and 12 weeks

Full study description

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.

Source references

references

citation
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.
pmid
28102098
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice