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Low-Carbohydrate Normocaloric Diet in Patients With Head and Neck Carcinoma (HNC) | Clinical Trials | Clareo Health

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Low-Carbohydrate Normocaloric Diet in Patients With Head and Neck Carcinoma (HNC)

A Pilot Trial of a Low-Carbohydrate Normocaloric Diet, in Patients With Head and Neck Carcinoma (HNC) and Its Effect on Stromal-Epithelial Metabolic Uncoupling

NCT02555176•Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

View on ClinicalTrials.gov

Summary

This pilot clinical trial studies the effects of a low carbohydrate diet on tumor metabolism in patients with head and neck cancer. A low carbohydrate diet may reduce the metabolic activity of cancer cells and of surrounding supportive tissues. Studying samples of tissue and blood from patients with head and neck cancer in the laboratory before and after a low carbohydrate diet may help determine any changes in tumor metabolism.

Detailed Description

PRIMARY OBJECTIVES: I. Assess the impact of a low-carbohydrate normocaloric diet on transporter of the outer mitochondrial membrane subunit 20 (TOMM20) expression by immunohistochemistry (IHC) in carcinoma cells and the impact of a low-carbohydrate normocaloric diet on monocarboxylate transporter 4 (MCT4) expression in fibroblasts. SECONDARY OBJECTIVES: I. Assess the feasibility of a low-carbohydrate normocaloric diet treatment in head and neck carcinoma (HNC) patients. II. Assess the effect of a low-carbohydrate normocaloric diet on the serum levels of insulin, and insulin growth factor (IGF)-1 and -2. III. Assess the potential impact of a low-carbohydrate normocaloric diet on the following: disease-free survival, distant metastases-free survival, overall survival. IV. To evaluate the utility of cancer-derived exosomes to serve as prognostic biomarkers for real-time monitoring of therapeutic efficacy and identifying early recurrence using longitudinal samples from cancer patients undergoing treatment. OUTLINE: Patients follow a normocaloric, low-carbohydrate diet for 10-28 days (from the time of cancer diagnosis to definitive surgical treatment). After completion of study, patients are followed up at 1 month, 3 months, and then every 3 months for 24 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with a diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at TJUH are eligible to participate.
•2. Subjects must be ≥ 18 and ≤ 70 years of age.
•3. KPS \> 70
•4. Expected survival \> 6 months.
•5. Adequate organ functions (hematological, hepatic, renal function).
•6. Absolute neutrophil count \> 1.5 x 109/L, platelet count \> 100 x 109/L, hemoglobin \> 9 g/L, total bilirubin \< 1.25 x the institutional upper limit of normal \[ULN\], albumin \> 2.5 g/dL, aspartate aminotransferase \< 45 IU/dL, alanine aminotransferase \< 40 IU/dL, alkaline phosphatase ≤ 190 IU/dL and serum creatinine \< 1.3 mg/dL and creatinine clearance \> 50 mL/min.
•7. Serum potassium and magnesium, and corrected serum calcium within the institution's normal reference range.
•8. Ability to provide written informed consent obtained prior to participation in the study.
•9. Women of childbearing potential (WOCBP) must be willing to use an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
•10. Patients' availability to check their weight twice per week, during the study duration.

Exclusion Criteria

•1. Diabetic patients are eligible but will be excluded if they are taking metformin, insulin or sulfonilureas.
•2. Patients with plasma alanine aminotransferase greater than 40 IU/dL.
•3. Patients with plasma aspartate aminotransferase greater than 45 IU/dL.
•4. Patients with plasma creatinine level greater than 1.3 mg/dL.
•5. Patients with plasma alkaline phosphatase greater than 190 IU/dL.
•6. Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis.
•7. Patients with history of congestive heart failure.
•8. Patients with myocardial ischemia or peripheral muscle ischemia.
•9. Patients with sepsis or severe infection.
•10. Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
+6 more criteria

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 14, 2016

Primary Completion Date

January 1, 2017

Completion Date

October 1, 2018

Last Updated

May 20, 2025

Enrollment

ACTUAL participants

Conditions

Head and Neck Carcinoma

Interventions

Dietary intervention

DIETARY_SUPPLEMENT

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

NCT05526924

Head and Neck CancerHead and Neck Squamous Cell Carcinoma+3 more

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RECRUITINGPHASE2

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

NCT05075980

Head and Neck CarcinomaHead and Neck Carcinoma of Unknown Primary+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Low-Carbohydrate Normocaloric Diet in Patients With Head and Neck Carcinoma (HNC)

Inclusion Criteria

Exclusion Criteria

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence