Clinical trial · Interventional
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer
The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy
NCT02575313CI-TRIAL-00019453terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of participant recruitment.
Summary
Brief summary (as posted)
This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.
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 |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Food Intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole Food Intervention Treated
- description
- Group of participants given the experimental WFI along with standard cancer treatment.
- interventionNames
- Dietary Supplement: Whole Food Intervention
Primary outcomes (1)
- measure
- Measurement of Tolerability
- timeFrame
- Eight (8) weeks
- description
- Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
Secondary outcomes (2)
- measure
- Mucositis Grading
- timeFrame
- Eight (8) weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed diagnosis of head \& neck carcinoma * Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy * No other serious concurrent medical illness as determined by the Principle Investigator * Absolute neutrophil count ≥ 500/mm3 * Platelet count ≥ 50,000/mm3 * No history of insulin-dependent diabetes mellitus * No prior hypersensitivity reaction to compound components Exclusion Criteria: * Dislike of the available forms of the WFI * Allergy or food intolerance relevant to the ingredients * Lack of access to refrigerated storage for the WFI * Inability or unwillingness to participate twice a week * Inability to swallow * Undergoing treatment for HIV with HIV medications * Ongoing alcohol and/or drug abuse
References
Publications (0)
Data not yet available
No reference posted for this study.