Ketogenic Diet Phase 1 for Head & Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Iowa
Sponsor:
Collaborators:
Nutricia North America
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Allen, Bryan G, University of Iowa
ClinicalTrials.gov Identifier:
NCT01975766
First received: October 29, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Dietary Supplement: Ketogenic diet
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

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


Secondary Outcome Measures:
  • Ketone levels [ Time Frame: Daily during treatment for 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Blood glucose levels [ Time Frame: daily during treatment for 5 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Oxidative stress parameters [ Time Frame: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up ] [ Designated as safety issue: No ]
    Determine oxidative stress parameters in plasma and urine samples during the course of treatment.

  • Progression Free Survival (months) [ Time Frame: Every 12 months for 60 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 9
Study Start Date: January 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Ketogenic diet
    A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975766

Contacts
Contact: Bryan G. Allen, MD, PhD (319) 356-3693 bryan-allen@uiowa.edu

Locations
United States, Iowa
Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt, RN, BSN, OCN    319-353-7143    sandy-vollstedt@uiowa.edu   
Contact: Heather Brown, RN, BAN, OCN    319-384-7912    heather-brown@uiowa.edu   
Sub-Investigator: Taher Abu Hejleh, MD         
Principal Investigator: Bryan G. Allen, MD, PhD         
Sub-Investigator: Carryn M Anderson, MD         
Sub-Investigator: Meg Bayless, CCRC, RN         
Sub-Investigator: Rodrigo Bayon, MD         
Sub-Investigator: Daniel Berg, MD         
Sub-Investigator: Kellie Bodeker         
Sub-Investigator: John M. Buatti, MD         
Sub-Investigator: Kristi Chang, MD         
Sub-Investigator: Julie Eichenberger-Gilmore, RD, LD, PhD         
Sub-Investigator: Melissa Fath, PhD         
Sub-Investigator: Gerry Funk, MD         
Sub-Investigator: Ami Gaarde, BSN         
Sub-Investigator: Henry Hoffman, MD         
Sub-Investigator: William Sivitz, MD         
Sub-Investigator: Brian J Smith, PhD         
Sub-Investigator: Wenqing Sun, MD, PhD         
Sub-Investigator: Mindi Tennapel, MBA, MS         
Sub-Investigator: Sandy Vollstedt, RN, BSN         
Sub-Investigator: Daniel Vaena, MD         
Sub-Investigator: Mohammed M Milhem, M.B.B.S         
Sub-Investigator: Heather Brown, RN, BAN, OCN         
Sponsors and Collaborators
University of Iowa
Nutricia North America
Holden Comprehensive Cancer Center
Investigators
Principal Investigator: Bryan G. Allen, MD, PhD The University of Iowa
  More Information

Additional Information:
Publications:
Responsible Party: Allen, Bryan G, Assistant Professor, Department of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01975766     History of Changes
Other Study ID Numbers: 201309759, 3P30CA086862
Study First Received: October 29, 2013
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Iowa:
Carcinoma, squamous cell of head and neck
Head and neck cancer
ketogenic diet
radiotherapy
cisplatin

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 18, 2014