CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
fruit and vegetable extracts +1 moredietary
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Curatively treated stage I-IV squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, hypopharynx, or larynx)
  • ✓Disease-free for at least 6 months and no more than 3 years after completion of curative treatment (surgery, radiotherapy, and/or chemotherapy)
  • ✓Age 18 and over
  • ✓Karnofsky 70-100% or Zubrod 0-1
Key exclusion· 7
  • ✕Synchronous tumors
  • ✕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)
  • ✕Pregnant or nursing
  • ✕Nausea ≥grade 2

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00064298
NCT00064298Phase 2Completed
CompareCT.gov

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

Wake Forest University Health Sciences·interventional·Posted Jul 9, 2003·Updated Sep 28, 2021

In Brief

A Phase 2 clinical trial evaluating fruit and vegetable extracts and placebo for Head and Neck Cancer. Completed, enrolled 134 participants across 28 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2003
Enrollment StartJan 1, 2004
Primary CompletionOct 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 23.0 years ago

Interventions

fruit and vegetable extractsdietary

Given orally

placebodietary

Given orally