Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes

NCT04253808 | Completed

• 1 other identifier: 19635
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the feasibility of a carbohydrate-restricted, high-fat (CRHF) diet intervention in newly diagnosed head and neck squamous cell carcinoma patients who will receive definitive radiation.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

non-metastatic

Outcome Measures

Primary Outcomes (21)

• Feasibility measure: Recruitment

  Recruitment will be measured by recording the number of patients screened, included, excluded, dropped-out, and completed the study throughout the study period.

  Through study completion, an average of 2 years

• Feasibility measure: Adherence

  Adherence will be measured by collecting daily food surveys that ask about daily food intake (checking the food items that have been consumed and providing information about any other additional foods that were consumed) as well as completing all study activities which are listed on a checklist.

  Throughout the 16.5 week study period (from baseline till the end of study)

• Feasibility measure: Retention

  Retention will be measured by recording the number of patients included or agreed to participate and completed all study protocol.

  Throughout 16.5 week study period (from baseline till the end of study)

• Blood Glucose

  Blood glucose level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Complete blood count (CBC)

  CBC levels were measured, recorded, and mentioned whether levels were normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Liver function

  Liver function tests were measured, recorded, and mentioned whether levels were normal, low, or high. These tests were done to assess whether liver function remained normal after consuming the diet or not. That was done by measuring the levels of GOT, GPT, and alkaline phosphatase in the blood and recording whether they were normal or not.

  Throughout the 8.5 weeks of intervention

• Kidney function

  Kidney function tests were measured, recorded, and mentioned whether levels were normal, low, or high. These tests were done to assess whether kidney function remained normal after consuming the diet or not. That was done by measuring the levels of BUN, creatinine, and uric acid in the blood and recording whether they were normal or not.

  Throughout the 8.5 weeks of intervention

• Potassium

  Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Phosphorus

  Throughout the 8.5 weeks of intervention

• Magnesium

  Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Sodium

  Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Chloride

  Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Calcium

  Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Albumin level

  Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• C-reactive protein (CRP) level

  CRP level was measured, recorded, and mentioned whether the level was normal, low, or high. High level indicates inflammation.

  Throughout the 8.5 weeks of intervention

• Total protein level

  Total protein level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Insulin level

  Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Triglycerides level

  Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.

  Throughout the 8.5 weeks of intervention

• Total cholesterol level

  Total cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• LDL-cholesterol level

  LDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

• HDL-cholesterol level

  HDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

  Throughout the 8.5 weeks of intervention

Secondary Outcomes (16)

• Tumor progression assessment

  Throughout 16.5 week study period (from baseline till the end of study)

• Nutritional status assessment

  Throughout 16.5 week study period (from baseline till the end of study)

• Percentage of body fat

  Throughout 16.5 week study period (from baseline till the end of study)

• Percentage of lean body mass

  Throughout 16.5 week study period (from baseline till the end of study)

• Percentage of body water

  Throughout 16.5 week study period (from baseline till the end of study)

Study Arms (3)

Arm A

EXPERIMENTAL

The experimental arm (N=6) were provided a CRHF diet with enough calories to maintain body weight for appoximately 2 weeks neoadjuvantly (during radiotherapy preparation) and adjuvantly during primary oncology treatment for \~6.5 weeks. The CRHF diet was composed of 45% fats (mostly) unsaturated fats, 25% proteins, and 30% carbohydrates.

Behavioral: Carbohydrate-restricted, high-fat diet

Arm B

ACTIVE COMPARATOR

Arm B (N=7) were provided a regular composition diet prescribed with enough calories to maintain body weight for approximately 2 weeks neoadjuvantly (during radiotherapy preparation) and adjuvantly during primary oncology treatment for \~6.5 weeks. The regular composition diet was composed of \~50-52% carbohydrates, \~30% fats, and 18-20% proteins,

Behavioral: Regular composition diet

Control group

NO INTERVENTION

The control group (N=26) followed applicable eligibility criteria but did not receive any intervention.

Interventions

Carbohydrate-restricted, high-fat diet BEHAVIORAL

Diet composition was \~45% fats, \~30% carbohydrates, and \~25% proteins. Calorie needs were provided according to what the Bioelectrical Impedance (BIA) device gave as required to maintain bodyweight. Sources of macronutrients: * Carbohydrates: from whole grains, dairy products, legumes, fruits, and vegetables. * Fats: from mono- and polyunsaturated fatty acids, including medium- and long-chain fatty acids. * Proteins: plant-based proteins and lean animal-based proteins. All meals were provided to the participants throughout the study period and the diet was provided orally unless the patient was on a feeding tube or a feeding tube is ordered by a physician during the study period. Diet texture was according to patients chewing and swallowing abilities. If the patient is on a feeding tube or intake is insufficient, a formula with similar macronutrient composition + a protein supplement was provided.

Also known as: CRHF diet

Arm A

Regular composition diet BEHAVIORAL

The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins

Arm B

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed with non-metastatic cancer of the oral cavity, hypopharynx, oropharynx, or larynx
• Plan to receive definitive radiation treatment at Augusta Victoria Hospital (AVH) in East Jerusalem
• Age \> 18
• Karnofsky Index of ≥70 %
• Normal liver and kidney function tests
• Able to understand and willingly sign a written informed consent document
• Lives in the West Bank or Gaza
• Has an oven/microwave and a refrigerator where they are staying
• Cancer stage 1-4 with no metastasis
• BMI \> 20 kg/m²

You may not qualify if:

• Have metastatic disease
• Will receive a palliative treatment
• On insulin treatment or other diabetic treatment
• Uncontrolled illness (e.g. active infection, symptomatic CHF, cardiac arrhythmia, or psychiatric illness)
• Received previous treatment for another primary cancer
• Diagnosed with an illness that requires dietary modifications (e.g. renal disease, liver disease, celiac disease, and inflammatory bowel disease)
• Already consuming a carbohydrate-restricted, high-fat diet
• On chronic system corticosteroids for any reason (inhaled corticosteroids are allowed);
• Pregnant or lactating women
• Body mass index (BMI) \< 20
• Will start treatment within \<2 weeks from screening day
• Requires parenteral nutrition

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Augusta Victoria Hospital, East Jerusalem: collaborator

Study Sites (1)

Augusta Victoria Hospital

East Jerusalem, Palestinian Territories

Location

Related Publications (1)

• Arthur AE, Goss AM, Demark-Wahnefried W, Mondul AM, Fontaine KR, Chen YT, Carroll WR, Spencer SA, Rogers LQ, Rozek LS, Wolf GT, Gower BA; University of Michigan Head and Neck SPORE Program. Higher carbohydrate intake is associated with increased risk of all-cause and disease-specific mortality in head and neck cancer patients: results from a prospective cohort study. Int J Cancer. 2018 Sep 1;143(5):1105-1113. doi: 10.1002/ijc.31413. Epub 2018 Apr 17.

  PMID: 29604042 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anna E Arthur, PhD, MPH

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded from the group they are assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 5, 2020
• Study Start: February 3, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)