Clinical trial · Interventional
Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
Phase I Randomized, Double-blind, Placebo-controlled Trial of the Effect of Temporary Dietary Antioxidant Depletion on Tumor Growth and Cachexia in Head and Neck Cancer Patients Receiving Chemoradiation Therapy
- 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: Eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer. PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADD | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Antioxidant-deficient diet (ADD)
- interventionNames
- Other: ADD
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Number of people with adverse events
- timeFrame
- 70 days
- description
- Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy-proven carcinoma of the oropharynx (regardless of primary diagnosis or recurrence) * No active treatment for disease within the past 4 weeks PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Feeding tubes allowed * Prior malignancies allowed provided all of the following criteria are met: * Patient has undergone potentially curative therapy for all prior malignancies * There has been no evidence of any prior malignancies within the past 5 years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrences) * Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies * Must be able to speak English * Must have adequate home refrigeration * No intractable vomiting * No ascites or clinical/ultrasound evidence of fluid retention * No uncontrolled hypertension * No severe congestive heart failure * No pneumonia * No severe infections * No known HIV positivity * No coexisting medical condition that would preclude study compliance * No decisionally-impaired individuals * No history of abetalipoproteinemia (Bassen-Kornzweig syndrome) * No history of spinocerebellar ataxia * No history of chronic cholestatic hepatobiliary disease * No history of diagnosed vitamin E deficiency * No history of protein-energy malnutrition (marasmus or kwashiorkor) * No history of disorders related to malabsorption (e.g., celiac disease, sprue, cystic fibrosis, duodenal bypass, congenital partial obstruction of the jejunum, obstruction of the bile ducts, giardiasis, or cirrhosis) * No history of achlorhydria PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent parenteral nutrition
References
Publications (0)
Data not yet available