Head and Neck CarcinomaNCT02555176
Low-Carbohydrate Normocaloric Diet in Patients With Head and Neck Carcinoma (HNC)
A study testing Dietary intervention in people with Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionDietary supplement
Follow a low-carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Up to 24 months after surgery
Secondary outcomes (7)
Feasibility of a low-carbohydrate normocaloric diet treatment in HNC patients
Analysis will be descriptive
Measured: Up to 28 days
Change in serum levels of insulin
Measured: Baseline to up to 24 months
Change in serum levels of IGF-1
Measured: Baseline to up to 24 months
Change in serum levels of IGF-2
Measured: Baseline to up to 24 months
Disease-free survival
Estimated using the Kaplan-Meier method.
Measured: Up to 24 months after surgery
Distant metastases-free survival
Estimated using the Kaplan-Meier method.
Measured: Up to 24 months after surgery
Overall survival
Estimated using the Kaplan-Meier method.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start14 Dec 2016
- Primary completionJan 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Curry, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555176
- Sponsor's protocol ID
- 15D.365
- Other IDs
- JT 5741
- Status last verified
- May 2025
- First submitted
- 9 Sep 2015
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02555176
- Acronym / sponsor ID
- 15D.365
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Dietary Supplement: Dietary interventionPatients follow a normocaloric, low-carbohydrate diet for 10-28 days (from the time of cancer diagnosis to definitive surgical treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionFollow a low-carbohydrate diet | Dietary supplement | Low Carbohydrate Diet |
Primary outcome
Change in TOMM20 expression by IHC
Time frame: Baseline to up to 28 days (day of surgery)
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.
Change in MCT4 expression in fibroblasts
Time frame: Baseline to up to 28 days (day of surgery)
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.
Incidence of adverse events, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 24 months after surgery
7 secondary outcomes
Feasibility of a low-carbohydrate normocaloric diet treatment in HNC patients
Time frame: Up to 28 days
Change in serum levels of insulin
Time frame: Baseline to up to 24 months
Change in serum levels of IGF-1
Time frame: Baseline to up to 24 months
Change in serum levels of IGF-2
Time frame: Baseline to up to 24 months
Disease-free survival
Time frame: Up to 24 months after surgery
Distant metastases-free survival
Time frame: Up to 24 months after surgery
Overall survival
Time frame: Up to 24 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Jefferson University HospitalsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Curry, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TOMM20 expression by IHC (time frame: Baseline to up to 28 days (day of surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.