Clinical trial · Interventional
Ketogenic Diet Phase 1 for Head & Neck Cancer
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer
NCT01975766CI-TRIAL-00033448terminatedN/AClinicalTrials.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): Poor accrual
Summary
Brief summary (as posted)
This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by patients.
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiation therapy | Device | — | UNRESOLVED |
| Ketogenic diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketogenic diet
- description
- Ketogenic diet designed to sustain ketone levels through treatment.
- interventionNames
- Dietary Supplement: Ketogenic diet
- Device: External beam radiation therapy
Primary outcomes (1)
- measure
- Frequency of adverse events (safety)
- timeFrame
- weekly for 5 weeks
- description
- Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
Secondary outcomes (4)
- measure
- Ketone levels
- timeFrame
- Daily during treatment for 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented squamous cell carcinoma of the oropharynx, larynx or hypopharynx. HPV status will not be assessed for eligibility; while HPV status may affect response to therapy, efficacy is not an outcome measure for this phase I study. * Candidate for primary chemoradiation as decided by an interdisciplinary team including otolaryngology, medical oncology, and radiation oncology. * Cancer should be staged via AJCC as stage II, III or IVa. * Age ≥ 18 years * ECOG performance status 0-2 (Karnofsky \> 50%, see Appendix A). * Patients must have normal organ and marrow function as defined below: * leukocytes ≥ 3,000/mm3 * absolute neutrophil count ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * total bilirubin \< 1.5 mg/dl * Hgb A1C \< 8% * AST(SGOT) \< 2 X institutional upper limit of normal * creatinine \< 1.5 X institutional upper limit of normal OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Not pregnant. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Life expectancy of 3 or less months. * Prior neck and/or upper thoracic radiotherapy that would cause an overlap of treatment fields. * Prior therapy to the head and neck, with the intent to treat, the current diagnosis of head \& neck cancer. * Known / established G6PD (glucose-6-phosphate dehydrogenase) deficiency. * Chronic system corticosteroids for any reason (inhaled corticosteroids are allowed). Pre-medication for chemotherapy is acceptable. * Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable). * Uncontrolled diabetes defined as a hemoglobin A1C level \> 8% (therapeutic action is indicated at greater than 8%). * Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by study team members. * Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
References
Publications (1)
- RESULTAllen BG, Bhatia SK, Buatti JM, Brandt KE, Lindholm KE, Button AM, Szweda LI, Smith BJ, Spitz DR, Fath MA. Ketogenic diets enhance oxidative stress and radio-chemo-therapy responses in lung cancer xenografts. Clin Cancer Res. 2013 Jul 15;19(14):3905-13. doi: 10.1158/1078-0432.CCR-12-0287. Epub 2013 Jun 6. PMID 23743570