Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

NCT01419587 | Terminated DMC

• 2 other identifiers: 2011027731R21CA161182
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 lung cancer patients.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Non small cell lung cancer; NSCLC; Ketogenic Diet; radiotherapy; paclitaxel; carboplatin

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 8 weeks

Secondary Outcomes (4)

• Ketone levels

  Daily during treatment for 6 weeks

• Blood glucose levels

  Daily during treatment for 6 weeks

• Oxidative stress parameters

  Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up

• Progression Free Survival (months)

  Every 12 months for 60 months

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

Diet formulated to maintain elevated ketones during therapy

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

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

Ketogenic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented NSCLC.
• Candidate for primary chemoradiation as decided by both medical and radiation oncology.
• Cancer should be staged via AJCC as IIIA or IIIB.
• Stage IV patients are considered provided they have a single non-CNS metastasis (that is amenable to treatment with radiation therapy).
• Age ≥ 18 years
• ECOG performance status 0-2 (Karnofsky \> 50%, see Appendix A).
• Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
• 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 \< or = to 8%
• AST(SGOT) \< or = to 2 X institutional upper limit of normal
• creatinine \< 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

You may not qualify if:

• Life expectancy of 3 or less months.
• Prior thoracic radiotherapy.
• Prior therapy, with the intent to treat, the current diagnosis of lung cancer.
• Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
• Systemic corticosteroids for any reason (inhaled corticosteroids are allowed).
• 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.
• Female and male patients of all ethnic groups will be eligible for treatment in these protocols.

Sponsors & Collaborators

• University of Iowa: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Nutricia North America: collaborator

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Zahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials. Radiat Res. 2017 Jun;187(6):743-754. doi: 10.1667/RR14668.1. Epub 2017 Apr 24.

  PMID: 28437190 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bryan G. Allen, MD, PhD

  The Department of Radiation Oncology, The 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 18, 2011
• Study Start: July 1, 2011
• Primary Completion: June 30, 2017
• Study Completion: July 11, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

US (1)