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

NCT02555176 | Completed DMC

• 2 other identifiers: 15D.365JT 5741
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (3)

• Change in TOMM20 expression by IHC

  IHC status will be classified as positive or negative pre-and post-treatment. Change in IHC status will be evaluated using McNemar's test for paired dichotomous data.

  Baseline to up to 28 days (day of surgery)

• Change in MCT4 expression in fibroblasts

  IHC status will be classified as positive or negative pre-and post-treatment. Change in IHC status will be evaluated using McNemar's test for paired dichotomous data.

  Baseline to up to 28 days (day of surgery)

• Incidence of adverse events, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0

  Up to 24 months after surgery

Secondary Outcomes (7)

• Feasibility of a low-carbohydrate normocaloric diet treatment in HNC patients

  Up to 28 days

• Change in serum levels of insulin

  Baseline to up to 24 months

• Change in serum levels of IGF-1

  Baseline to up to 24 months

• Change in serum levels of IGF-2

  Baseline to up to 24 months

• Disease-free survival

  Up to 24 months after surgery

Study Arms (1)

Low Carbohydrate Diet

EXPERIMENTAL

Patients follow a normocaloric, low-carbohydrate diet for 10-28 days (from the time of cancer diagnosis to definitive surgical treatment).

Dietary Supplement: Dietary intervention

Interventions

Dietary intervention DIETARY_SUPPLEMENT

Follow a low-carbohydrate diet

Low Carbohydrate Diet

Eligibility Criteria

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

You may qualify if:

• 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.
• Subjects must be ≥ 18 and ≤ 70 years of age.
• KPS \> 70
• Expected survival \> 6 months.
• Adequate organ functions (hematological, hepatic, renal function).
• 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.
• Serum potassium and magnesium, and corrected serum calcium within the institution's normal reference range.
• Ability to provide written informed consent obtained prior to participation in the study.
• 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.
• Patients' availability to check their weight twice per week, during the study duration.

You may not qualify if:

• Diabetic patients are eligible but will be excluded if they are taking metformin, insulin or sulfonilureas.
• Patients with plasma alanine aminotransferase greater than 40 IU/dL.
• Patients with plasma aspartate aminotransferase greater than 45 IU/dL.
• Patients with plasma creatinine level greater than 1.3 mg/dL.
• Patients with plasma alkaline phosphatase greater than 190 IU/dL.
• Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis.
• Patients with history of congestive heart failure.
• Patients with myocardial ischemia or peripheral muscle ischemia.
• Patients with sepsis or severe infection.
• Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
• Patients scheduled for definitive HNC cancer surgical resection less than 10 days from enrollment or greater than five weeks from enrollment.
• Patients with history of hepatic dysfunction or hepatic disease.
• Patients with a history of excessive alcohol intake which is defined in accordance with CDC definitions as more than 1 drink per day for women and more than 2 drinks per day for men. This definition is referring to the amount consumed on any single day and is not intended as an average over several days. A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey).
• Patients with a lower BMI (BMI\<18) will be excluded.
• Patients with history of known defects in fat metabolism (ie pyruvate carboxylase deficiency, prophyria, fatty acid oxidation defects, primary carnitine deficiencies, organic acidurias, hypoglicemia) will be excluded.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Jefferson University Hospitals

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Joseph Curry, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 21, 2015
• Study Start: December 14, 2016
• Primary Completion: January 1, 2017
• Study Completion: October 1, 2018
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)