Ketogenic Diet Phase 1 for Head & Neck Cancer

Stopped early · Not applicable

Conditions studied: Head and Neck Neoplasms

In brief

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.

Key facts

Study ID

NCT01975766

Run by

Bryan Allen

People needed

14

Starts

2014-01-01

Expected to finish

2017-07-11

Last updated by the study team

2018-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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