Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes
NCT ID: NCT04253808
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2020-02-03
2021-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm A
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.
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.
Arm B
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,
Regular composition diet
The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins
Control group
The control group (N=26) followed applicable eligibility criteria but did not receive any intervention.
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Augusta Victoria Hospital, East Jerusalem
UNKNOWN
University of Illinois at Urbana-Champaign
OTHER
Responsible Party
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Anna Arthur
Assistant Professor
Principal Investigators
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Anna E Arthur, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Urbana-Champaign
Locations
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Augusta Victoria Hospital
East Jerusalem, , Palestinian Territories
Countries
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References
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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.
Other Identifiers
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19635
Identifier Type: -
Identifier Source: org_study_id