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

Not Applicable

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Behavioral: Carbohydrate-restricted, high-fat diet; Behavioral: Regular composition diet

• Registration Number: NCT04253808
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Our previous observational research indicates that a pretreatment diet high in total carbohydrates is associated with increased risk of all-cause and disease-specific mortality in head and neck cancer. The purpose of this study is to conduct a single-blinded randomized controlled trial to test the feasibility of a carbohydrate-restricted, high-fat (CRHF) diet intervention in newly diagnosed head and neck cell squamous carcinoma (HNSCC) patients who will receive definitive radiation. The secondary aim is to collect preliminary data on the effect of the intervention on tumor progression, nutritional status, body composition, quality of life, and symptom burden.

Thirteen newly diagnosed HNSCC non-metastatic patients were recruited from Augusta Victoria Hospital in East Jerusalem and randomized into one of two arms; a carbohydrate-restricted, high-fat diet arm (arm A) and a regular diet composition arm (Arm B). Arm A (N=6) were provided a CRHF diet both neoadjuvantly (for 2 weeks prior to treatment) and adjuvantly (during treatment with radiation). Arm B (N=7) received standard oncologic treatment including a regular diet (50-52% carbohydrates, 30% fats, and 18-20% proteins). Feasibility outcomes, including recruitment, retention, intervention adherence, and safety were tracked weekly. Biomarkers, tumor progression, nutritional status, body composition, QOL, and symptoms were assessed at baseline, 2-weeks, and 2-3 months post-treatment. A control group (N=26) included HNSCC patients who follow the same applicable eligibility criteria and did not receive any kind of dietary intervention. Medical information were collected retrospectively from the control group patients' files. Information on demographics (age, sex, smoking status, weight, height, marital status, education, occupation, and residency), tumor site, cancer stage, treatment dose reduction, treatment break, early cessation of treatment, hospitalization, symptoms, and weight loss, were collected during treatment from arms A and B and retrospectively from the control group.

This proposed pilot/feasibility study is the first step in determining if a CRHF diet is an effective treatment modality in cancer and if providing a diet with any composition before and during treatment is more beneficial than not providing a diet at all.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-31
• Study Start: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

Exclusion Criteria

1. Those who do not meet the inclusion criteria
2. Have metastatic disease
3. Will receive a palliative treatment
4. On insulin treatment or other diabetic treatment
5. Uncontrolled illness (e.g. active infection, symptomatic CHF, cardiac arrhythmia, or psychiatric illness)
6. Received previous treatment for another primary cancer
7. Diagnosed with an illness that requires dietary modifications (e.g. renal disease, liver disease, celiac disease, and inflammatory bowel disease)
8. Already consuming a carbohydrate-restricted, high-fat diet
9. On chronic system corticosteroids for any reason (inhaled corticosteroids are allowed);
10. Pregnant or lactating women
11. Body mass index (BMI) < 20
12. Will start treatment within <2 weeks from screening day
13. Requires parenteral nutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Carbohydrate-restricted, high-fat diet	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.
Arm B	Regular composition diet	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,

Primary Outcome Measures

Name	Time	Method
Complete blood count (CBC)	Throughout the 8.5 weeks of intervention	CBC levels were measured, recorded, and mentioned whether levels were normal, low, or high.
Feasibility measure: Adherence	Throughout the 16.5 week study period (from baseline till the end of study)	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.
Feasibility measure: Retention	Throughout 16.5 week study period (from baseline till the end of study)	Retention will be measured by recording the number of patients included or agreed to participate and completed all study protocol.
Kidney function	Throughout the 8.5 weeks of intervention	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.
Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention	Phosphorus
Chloride	Throughout the 8.5 weeks of intervention	Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.
Potassium	Throughout the 8.5 weeks of intervention	Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Magnesium	Throughout the 8.5 weeks of intervention	Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Calcium	Throughout the 8.5 weeks of intervention	Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Albumin level	Throughout the 8.5 weeks of intervention	Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high.
C-reactive protein (CRP) level	Throughout the 8.5 weeks of intervention	CRP level was measured, recorded, and mentioned whether the level was normal, low, or high. High level indicates inflammation.
Blood Glucose	Throughout the 8.5 weeks of intervention	Blood glucose level was measured, recorded, and mentioned whether the level was normal, low, or high.
Liver function	Throughout the 8.5 weeks of intervention	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.
Insulin level	Throughout the 8.5 weeks of intervention	Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.
Sodium	Throughout the 8.5 weeks of intervention	Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Feasibility measure: Recruitment	Through study completion, an average of 2 years	Recruitment will be measured by recording the number of patients screened, included, excluded, dropped-out, and completed the study throughout the study period.
HDL-cholesterol level	Throughout the 8.5 weeks of intervention	HDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.
Total cholesterol level	Throughout the 8.5 weeks of intervention	Total cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.
Total protein level	Throughout the 8.5 weeks of intervention	Total protein level was measured, recorded, and mentioned whether the level was normal, low, or high.
Triglycerides level	Throughout the 8.5 weeks of intervention	Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.
LDL-cholesterol level	Throughout the 8.5 weeks of intervention	LDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

Secondary Outcome Measures

Name	Time	Method
Basal metabolic rate (BMR)	Throughout 16.5 week study period (from baseline till the end of study)	BMR was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition.
Nutritional status assessment	Throughout 16.5 week study period (from baseline till the end of study)	Nutritional status was assessed using the "Patient generated subjective global assessment" (PG-SGA) tool.
Hospitalization	Throughout the 8.5 weeks of intervention	We recorded whether the participant was hospitalized or not.
Weight loss	Throughout 16.5 week study period (from baseline till the end of study)	We recorded whether the participant had weight loss or not
Amount and span of weight loss	Throughout 16.5 week study period (from baseline till the end of study)	If the participant had weight loss, we recorded how much he had lost and during what time span
Treatment break	Throughout the 6.5 weeks of treatment	We recorded whether there was treatment break and the reason for that.
Tumor progression assessment	Throughout 16.5 week study period (from baseline till the end of study)	Tumor progression was assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging.
Symptom burden assessment	Throughout 16.5 week study period (from baseline till the end of study)	Symptom burden was assessed using the validated Memorial Symptom Assessment Survey.
Early cessation of treatment	Throughout the 8.5 weeks of treatment	We recorded whether there was early cessation of treatment and the reason for that.
Percentage of body fat	Throughout 16.5 week study period (from baseline till the end of study)	The percentage of body fat was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition.
Percentage of lean body mass	Throughout 16.5 week study period (from baseline till the end of study)	The percentage of lean body mass was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition.
Percentage of body water	Throughout 16.5 week study period (from baseline till the end of study)	The percentage of body water was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition.
Quality of life assessment	Throughout 16.5 week study period (from baseline till the end of study)	Quality of life was assessed using EORTC QLQ questionnaires.
Duration of hospitalization	Throughout the 8.5 weeks of intervention	If the participant was hospitalized, we recorded the duration of each hospitalization
Number of hospitalizations	Throughout the 8.5 weeks of intervention	If the participant was hospitalized, we recorded the number of hospitalizations
Treatment dose reduction	Throughout the 6.5 weeks of treatment	We recorded whether there was treatment dose reduction and the reason for that.

Trial Locations

Locations (1)

Augusta Victoria Hospital; 🇵🇸 East Jerusalem, Palestinian Territory, occupied