Clinical trial · Interventional
Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
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
NCT00064298CI-TRIAL-00054140completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fruit and vegetable extracts | Dietary Supplement | — | UNRESOLVED |
| placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I - JuicePlus
- description
- Patients receive oral fruit and vegetable extracts twice daily.
- interventionNames
- Dietary Supplement: fruit and vegetable extracts
- type
- PLACEBO_COMPARATOR
- label
- Arm II - Control
- description
- Patients receive oral placebo twice daily.
- interventionNames
- Dietary Supplement: placebo
Primary outcomes (1)
- measure
- Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
- timeFrame
- baseline and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E\])
References
Publications (1)
- DERIVEDDatta 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