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Ketogenic Diet Phase 1 for Head & Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01975766
Recruitment Status : Terminated (Poor accrual)
First Posted : November 5, 2013
Last Update Posted : June 25, 2018
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Nutricia North America
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Bryan Allen, University of Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Dietary Supplement: Ketogenic diet Device: External beam radiation therapy Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer
Study Start Date : January 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : July 11, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ketogenic diet
Ketogenic diet designed to sustain ketone levels through treatment.
Dietary Supplement: Ketogenic diet
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

Device: External beam radiation therapy
Other Names:
  • radiation therapy
  • intensity modulated radiation therapy
  • IMRT

Primary Outcome Measures :
  1. Frequency of adverse events (safety) [ Time Frame: weekly for 5 weeks ]
    Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.

Secondary Outcome Measures :
  1. Ketone levels [ Time Frame: Daily during treatment for 5 weeks ]
    Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.

  2. Blood glucose levels [ Time Frame: daily during treatment for 5 weeks ]
    Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.

  3. Oxidative stress parameters [ Time Frame: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up ]
    Determine oxidative stress parameters in plasma and urine samples during the course of treatment.

  4. Progression Free Survival (months) [ Time Frame: Every 12 months for 60 months ]
    From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01975766

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United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Bryan Allen
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Nutricia North America
Holden Comprehensive Cancer Center
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Principal Investigator: Bryan G. Allen, MD, PhD University of Iowa

Publications of Results:
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Responsible Party: Bryan Allen, Assistant Professor, Department of Radiation Oncology, University of Iowa Identifier: NCT01975766     History of Changes
Other Study ID Numbers: 201309759
3P30CA086862 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared on

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryan Allen, University of Iowa:
Carcinoma, squamous cell of head and neck
Head and neck cancer
ketogenic diet
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site