Clinical trial NCT04253808: Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: non-metastatic
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Augusta Victoria Hospital, East Jerusalem
First posted: 2020-02-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility measure: Recruitment
timeFrame: Through study completion, an average of 2 years
measure: Feasibility measure: Adherence
timeFrame: Throughout the 16.5 week study period (from baseline till the end of study)
measure: Feasibility measure: Retention
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Blood Glucose
timeFrame: Throughout the 8.5 weeks of intervention
measure: Complete blood count (CBC)
timeFrame: Throughout the 8.5 weeks of intervention
measure: Liver function
timeFrame: Throughout the 8.5 weeks of intervention
measure: Kidney function
timeFrame: Throughout the 8.5 weeks of intervention
measure: Potassium
timeFrame: Throughout the 8.5 weeks of intervention
measure: Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.
timeFrame: Throughout the 8.5 weeks of intervention
measure: Magnesium
timeFrame: Throughout the 8.5 weeks of intervention
measure: Sodium
timeFrame: Throughout the 8.5 weeks of intervention
measure: Chloride
timeFrame: Throughout the 8.5 weeks of intervention
measure: Calcium
timeFrame: Throughout the 8.5 weeks of intervention
measure: Albumin level
timeFrame: Throughout the 8.5 weeks of intervention
measure: C-reactive protein (CRP) level
timeFrame: Throughout the 8.5 weeks of intervention
measure: Total protein level
timeFrame: Throughout the 8.5 weeks of intervention
measure: Insulin level
timeFrame: Throughout the 8.5 weeks of intervention
measure: Triglycerides level
timeFrame: Throughout the 8.5 weeks of intervention
measure: Total cholesterol level
timeFrame: Throughout the 8.5 weeks of intervention
measure: LDL-cholesterol level
timeFrame: Throughout the 8.5 weeks of intervention
measure: HDL-cholesterol level
timeFrame: Throughout the 8.5 weeks of intervention
Secondary outcomes:
measure: Tumor progression assessment
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Nutritional status assessment
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Percentage of body fat
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Percentage of lean body mass
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Percentage of body water
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Basal metabolic rate (BMR)
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Quality of life assessment
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Symptom burden assessment
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Hospitalization
timeFrame: Throughout the 8.5 weeks of intervention
measure: Number of hospitalizations
timeFrame: Throughout the 8.5 weeks of intervention
measure: Duration of hospitalization
timeFrame: Throughout the 8.5 weeks of intervention
measure: Weight loss
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Amount and span of weight loss
timeFrame: Throughout 16.5 week study period (from baseline till the end of study)
measure: Treatment dose reduction
timeFrame: Throughout the 6.5 weeks of treatment
measure: Treatment break
timeFrame: Throughout the 6.5 weeks of treatment
measure: Early cessation of treatment
timeFrame: Throughout the 8.5 weeks of treatment
Other outcomes:
Locations:
city: East Jerusalem
country: Palestinian Territory, occupied
facility: Augusta Victoria Hospital
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Anna E Arthur, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.