Clinical trial · Interventional
Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes
Feasibility of a Carbohydrate-restricted, High-fat Diet to Improve Outcomes in Head and Neck Squamous Cell Carcinoma: A Pilot Randomized Controlled Feeding Trial
NCT04253808CI-TRIAL-00054908CRHFcompletedN/AClinicalTrials.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)
This study will test the feasibility of a carbohydrate-restricted, high-fat (CRHF) diet intervention in newly diagnosed head and neck squamous cell carcinoma patients who will receive definitive radiation.
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 Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbohydrate-restricted, high-fat diet | Behavioral | — | UNRESOLVED |
| Regular composition diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- The experimental arm (N=6) were provided a CRHF diet with enough calories to maintain body weight for appoximately 2 weeks neoadjuvantly (during radiotherapy preparation) and adjuvantly during primary oncology treatment for \~6.5 weeks. The CRHF diet was composed of 45% fats (mostly) unsaturated fats, 25% proteins, and 30% carbohydrates.
- interventionNames
- Behavioral: Carbohydrate-restricted, high-fat diet
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Arm B (N=7) were provided a regular composition diet prescribed with enough calories to maintain body weight for approximately 2 weeks neoadjuvantly (during radiotherapy preparation) and adjuvantly during primary oncology treatment for \~6.5 weeks. The regular composition diet was composed of \~50-52% carbohydrates, \~30% fats, and 18-20% proteins,
- interventionNames
- Behavioral: Regular composition diet
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed with non-metastatic cancer of the oral cavity, hypopharynx, oropharynx, or larynx 2. Plan to receive definitive radiation treatment at Augusta Victoria Hospital (AVH) in East Jerusalem 3. Age \> 18 4. Karnofsky Index of ≥70 % 5. Normal liver and kidney function tests 6. Able to understand and willingly sign a written informed consent document 7. Lives in the West Bank or Gaza 8. Has an oven/microwave and a refrigerator where they are staying 9. Cancer stage 1-4 with no metastasis 10. BMI \> 20 kg/m² Exclusion Criteria: 1. Those who do not meet the inclusion criteria 2. Have metastatic disease 3. Will receive a palliative treatment 4. On insulin treatment or other diabetic treatment 5. Uncontrolled illness (e.g. active infection, symptomatic CHF, cardiac arrhythmia, or psychiatric illness) 6. Received previous treatment for another primary cancer 7. Diagnosed with an illness that requires dietary modifications (e.g. renal disease, liver disease, celiac disease, and inflammatory bowel disease) 8. Already consuming a carbohydrate-restricted, high-fat diet 9. On chronic system corticosteroids for any reason (inhaled corticosteroids are allowed); 10. Pregnant or lactating women 11. Body mass index (BMI) \< 20 12. Will start treatment within \<2 weeks from screening day 13. Requires parenteral nutrition
References
Publications (2)
- BACKGROUNDArthur AE, Goss AM, Demark-Wahnefried W, Mondul AM, Fontaine KR, Chen YT, Carroll WR, Spencer SA, Rogers LQ, Rozek LS, Wolf GT, Gower BA; University of Michigan Head and Neck SPORE Program. Higher carbohydrate intake is associated with increased risk of all-cause and disease-specific mortality in head and neck cancer patients: results from a prospective cohort study. Int J Cancer. 2018 Sep 1;143(5):1105-1113. doi: 10.1002/ijc.31413. Epub 2018 Apr 17. PMID 29604042
- DERIVEDTaha HM, Holscher HD, Atrash F, Slade AN, Maino Vieytes CA, Pan YX, Arthur AE. Medically Tailored Meals During Radiotherapy for Head and Neck Cancer: A Pilot Randomized Controlled Trial. Nutr Cancer. 2026;78(3):233-246. doi: 10.1080/01635581.2025.2608398. Epub 2026 Jan 16. PMID 41542842