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Head and Neck CancerPhase 2NCT00064298

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

A Phase 2 study testing fruit and vegetable extracts in people with Head and Neck Cancer, run by Wake Forest University Health Sciences at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
fruit and vegetable extracts
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
28 sitesUnited States
Study dates
1 Jan 2004to 1 Apr 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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])

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • MBCCOP - JHS Hospital of Cook County

    Chicago, Illinois, 60612

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Hugh Chatham Memorial Hospital

    Elkin, North Carolina, 28621

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Caldwell Memorial Hospital

    Lenoir, North Carolina, 28645

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Redwood Regional Medical Group

    Santa Rosa, California, 95405

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65804

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1030

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
fruit and vegetable extracts, placebo
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fruit and vegetable extractsDietary supplement

    Given orally

  • placeboDietary supplement

    Given orally

Study groups in NCT00064298
Study groupRoleWhat they receive
Arm I - JuicePlusExperimentalPatients receive oral fruit and vegetable extracts twice daily.
Receives: Dietary Supplement: fruit and vegetable extracts
Arm II - ControlPlacebo comparatorPatients receive oral placebo twice daily.
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 12 weeks

Secondary outcomes (1)

  1. 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.

    Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study start1 Jan 2004
  3. Primary completion1 Oct 2008
  4. Study completion1 Apr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064298
Sponsor's protocol ID
REBAWFU-60A02
Other IDs
U10CA081851
Status last verified
Sep 2021
First submitted
8 Jul 2003
Last updated
28 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28102098

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fruit and vegetable extracts in people with Head and Neck Cancer, run by Wake Forest University Health Sciences at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12 (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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