Ketogenic Diet Phase 1 for Head & Neck Cancer

Bryan Allen

Status

Terminated

Conditions

Head and Neck Neoplasms

Treatments

Dietary Supplement: Ketogenic diet

Device: External beam radiation therapy

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01975766

201309759

3P30CA086862 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Standard treatment for head & neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation).

This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for head & neck cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing.

Participants will:

Utilize a specialized ketogenic diet designed by bionutritional services of the clinical research unit. This diet begins 2 days before chemoradiation and continues through at least 5 weeks of chemoradiation.
Have blood drawn for research purposes weekly to determine measurements of oxidative stress
Have urine collected sporadically through the study to determine measurements of oxidative stress
Keep a diary of concomitant medications, side effects, and blood sugars
Have follow-up to monitor for outcomes and overall survival

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.