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

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Behavioral: Regular composition diet; Behavioral: Carbohydrate-restricted, high-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04253808

19635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Behavioral: Carbohydrate-restricted, high-fat diet

Arm B

Active Comparator group

Description:

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,

Treatment:

Behavioral: Regular composition diet

Control group

No Intervention group

Description:

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