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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
39
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.
The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins
Augusta Victoria Hospital
East Jerusalem, Palestinian Territories
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 8.5 weeks of intervention
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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.
Time frame: Throughout the 8.5 weeks of intervention
Potassium
Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.
Phosphorus
Time frame: Throughout the 8.5 weeks of intervention
Magnesium
Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Sodium
Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Chloride
Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Calcium
Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Albumin level
Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 8.5 weeks of intervention
Insulin level
Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.
Time frame: Throughout the 8.5 weeks of intervention
Triglycerides level
Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 8.5 weeks of intervention
Tumor progression assessment
Tumor progression was assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Nutritional status assessment
Nutritional status was assessed using the "Patient generated subjective global assessment" (PG-SGA) tool.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Percentage of body fat
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.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Percentage of lean body mass
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.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Percentage of body water
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.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Basal metabolic rate (BMR)
BMR was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Quality of life assessment
Quality of life was assessed using EORTC QLQ questionnaires.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Symptom burden assessment
Symptom burden was assessed using the validated Memorial Symptom Assessment Survey.
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Hospitalization
We recorded whether the participant was hospitalized or not.
Time frame: Throughout the 8.5 weeks of intervention
Number of hospitalizations
If the participant was hospitalized, we recorded the number of hospitalizations
Time frame: Throughout the 8.5 weeks of intervention
Duration of hospitalization
If the participant was hospitalized, we recorded the duration of each hospitalization
Time frame: Throughout the 8.5 weeks of intervention
Weight loss
We recorded whether the participant had weight loss or not
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Amount and span of weight loss
If the participant had weight loss, we recorded how much he had lost and during what time span
Time frame: Throughout 16.5 week study period (from baseline till the end of study)
Treatment dose reduction
We recorded whether there was treatment dose reduction and the reason for that.
Time frame: Throughout the 6.5 weeks of treatment
Treatment break
We recorded whether there was treatment break and the reason for that.
Time frame: Throughout the 6.5 weeks of treatment
Early cessation of treatment
We recorded whether there was early cessation of treatment and the reason for that.
Time frame: Throughout the 8.5 weeks of treatment