NCT00064298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

4.8 years

First QC Date

July 8, 2003

Results QC Date

May 8, 2017

Last Update Submit

September 7, 2021

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (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.

    baseline and 12 weeks

Secondary Outcomes (1)

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

    baseline and 12 weeks

Study Arms (2)

Arm I - JuicePlus

EXPERIMENTAL

Patients receive oral fruit and vegetable extracts twice daily.

Dietary Supplement: fruit and vegetable extracts

Arm II - Control

PLACEBO COMPARATOR

Patients receive oral placebo twice daily.

Dietary Supplement: placebo

Interventions

fruit and vegetable extractsDIETARY_SUPPLEMENT

Given orally

Arm I - JuicePlus
placeboDIETARY_SUPPLEMENT

Given orally

Arm II - Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 \[8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (28)

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

Redwood Regional Medical Group

Santa Rosa, California, 95405, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MBCCOP - JHS Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

Hugh Chatham Memorial Hospital

Elkin, North Carolina, 28621, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27835-6028, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1030, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Related Publications (1)

  • 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: 28102098DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Fruit

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Doug Case
Organization
Wake Forest NCORP Research Base
dcase@wakehealth.edu
(336) 716-1048

Study Officials

  • Steven A. Akman, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

January 1, 2004

Primary Completion

October 1, 2008

Study Completion

April 1, 2009

Last Updated

September 28, 2021

Results First Posted

July 24, 2017

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(28)