NCT01975766

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

October 29, 2013

Last Update Submit

June 21, 2018

Conditions

Head and Neck Neoplasms

Keywords

Carcinoma, squamous cell of head and neckHead and neck cancerketogenic dietradiotherapycisplatin

Outcome Measures

Primary Outcomes (1)

  • Frequency of adverse events (safety)

    Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.

    weekly for 5 weeks

Secondary Outcomes (4)

  • Ketone levels

    Daily during treatment for 5 weeks

  • Blood glucose levels

    daily during treatment for 5 weeks

  • Oxidative stress parameters

    Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up

  • Progression Free Survival (months)

    Every 12 months for 60 months

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

Ketogenic diet designed to sustain ketone levels through treatment.

Dietary Supplement: Ketogenic dietDevice: External beam radiation therapy

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

Ketogenic diet
External beam radiation therapyDEVICE
Also known as: radiation therapy, intensity modulated radiation therapy, IMRT
Ketogenic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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%).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Allen 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: 23743570RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Diet, KetogenicRadiotherapyRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaRadiotherapy, ConformalRadiotherapy, Computer-Assisted

Study Officials

  • Bryan G. Allen, MD, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Radiation Oncology

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 5, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2016

Study Completion

July 11, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

Data will be shared on clinicaltrials.gov

Locations

US(1)