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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— CRHF  

Official title:

Feasibility of a Carbohydrate-restricted, High-fat Diet to Improve Outcomes in Head and Neck Squamous Cell Carcinoma: A Pilot Randomized Controlled Feeding Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253808
• Other study ID #: 19635
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: October 2021
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Behavioral:
• Carbohydrate-restricted, high-fat diet
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.
• Regular composition diet
The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins

Locations

Country	Name	City	State
Palestinian Territory, occupied	Augusta Victoria Hospital	East Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Augusta Victoria Hospital, East Jerusalem

Country where clinical trial is conducted

Palestinian Territory, occupied, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Potassium	Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.	Phosphorus	Throughout the 8.5 weeks of intervention
Primary	Magnesium	Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Sodium	Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Chloride	Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Calcium	Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Albumin level	Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	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
Primary	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
Primary	Insulin level	Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	Triglycerides level	Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.	Throughout the 8.5 weeks of intervention
Primary	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
Primary	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
Primary	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	Tumor progression assessment	Tumor progression was assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Nutritional status assessment	Nutritional status was assessed using the "Patient generated subjective global assessment" (PG-SGA) tool.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	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.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	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.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	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.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	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.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Quality of life assessment	Quality of life was assessed using EORTC QLQ questionnaires.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Symptom burden assessment	Symptom burden was assessed using the validated Memorial Symptom Assessment Survey.	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Hospitalization	We recorded whether the participant was hospitalized or not.	Throughout the 8.5 weeks of intervention
Secondary	Number of hospitalizations	If the participant was hospitalized, we recorded the number of hospitalizations	Throughout the 8.5 weeks of intervention
Secondary	Duration of hospitalization	If the participant was hospitalized, we recorded the duration of each hospitalization	Throughout the 8.5 weeks of intervention
Secondary	Weight loss	We recorded whether the participant had weight loss or not	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Amount and span of weight loss	If the participant had weight loss, we recorded how much he had lost and during what time span	Throughout 16.5 week study period (from baseline till the end of study)
Secondary	Treatment dose reduction	We recorded whether there was treatment dose reduction and the reason for that.	Throughout the 6.5 weeks of treatment
Secondary	Treatment break	We recorded whether there was treatment break and the reason for that.	Throughout the 6.5 weeks of treatment
Secondary	Early cessation of treatment	We recorded whether there was early cessation of treatment and the reason for that.	Throughout the 8.5 weeks of treatment