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Head and Neck Squamous Cell CarcinomaCRHFNCT04253808

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

A study testing Carbohydrate-restricted, high-fat diet and Regular composition diet in people with Head and Neck Squamous Cell Carcinoma, run by University of Illinois at Urbana-Champaign at 1 site in Palestinian Territories.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Carbohydrate-restricted, high-fat diet and Regular composition diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 sitePalestinian Territories
Study dates
3 Feb 2020to 10 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed with non-metastatic cancer of the oral cavity, hypopharynx, oropharynx, or larynx
  • Plan to receive definitive radiation treatment at Augusta Victoria Hospital (AVH) in East Jerusalem
  • Age > 18
  • Karnofsky Index of ≥70 %
  • Normal liver and kidney function tests
  • Able to understand and willingly sign a written informed consent document
Show all 10Show fewer
  • Lives in the West Bank or Gaza
  • Has an oven/microwave and a refrigerator where they are staying
  • Cancer stage 1-4 with no metastasis
  • BMI > 20 kg/m²

Who cannot join

  • Those who do not meet the inclusion criteria
  • Have metastatic disease
  • Will receive a palliative treatment
  • On insulin treatment or other diabetic treatment
  • Uncontrolled illness (e.g. active infection, symptomatic CHF, cardiac arrhythmia, or psychiatric illness)
  • Received previous treatment for another primary cancer
Show all 13Show fewer
  • Diagnosed with an illness that requires dietary modifications (e.g. renal disease, liver disease, celiac disease, and inflammatory bowel disease)
  • Already consuming a carbohydrate-restricted, high-fat diet
  • On chronic system corticosteroids for any reason (inhaled corticosteroids are allowed);
  • Pregnant or lactating women
  • Body mass index (BMI) < 20
  • Will start treatment within <2 weeks from screening day
  • Requires parenteral nutrition

Trial locations and contacts

1 site in 1 country.

Palestinian Territories1 site

  • Augusta Victoria Hospital

    East Jerusalem

Other trials in Palestinian Territories

About this study

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

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.

Read the 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.

Being tested
Carbohydrate-restricted, high-fat diet, Regular composition diet
Keywords
non-metastatic
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbohydrate-restricted, high-fat dietBehavioural

    Also called CRHF 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 dietBehavioural

    The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins

Study groups in NCT04253808
Study groupRoleWhat they receive
Arm AExperimentalThe 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.
Receives: Behavioral: Carbohydrate-restricted, high-fat diet
Arm BActive comparatorArm 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,
Receives: Behavioral: Regular composition diet
Control groupNo interventionThe control group (N=26) followed applicable eligibility criteria but did not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 2 years

  2. 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.

    Measured: Throughout the 16.5 week study period (from baseline till the end of study)

  3. Feasibility measure: Retention

    Retention will be measured by recording the number of patients included or agreed to participate and completed all study protocol.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  4. Blood Glucose

    Blood glucose level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  5. Complete blood count (CBC)

    CBC levels were measured, recorded, and mentioned whether levels were normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  6. 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.

    Measured: Throughout the 8.5 weeks of intervention

  7. 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.

    Measured: Throughout the 8.5 weeks of intervention

  8. Potassium

    Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  9. Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Phosphorus

    Measured: Throughout the 8.5 weeks of intervention

  10. Magnesium

    Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  11. Sodium

    Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  12. Chloride

    Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  13. Calcium

    Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  14. Albumin level

    Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  15. C-reactive protein (CRP) level

    CRP level was measured, recorded, and mentioned whether the level was normal, low, or high. High level indicates inflammation.

    Measured: Throughout the 8.5 weeks of intervention

  16. Total protein level

    Total protein level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  17. Insulin level

    Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  18. Triglycerides level

    Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  19. Total cholesterol level

    Total cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  20. LDL-cholesterol level

    LDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

  21. HDL-cholesterol level

    HDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.

    Measured: Throughout the 8.5 weeks of intervention

Secondary outcomes (16)

  1. Tumor progression assessment

    Tumor progression was assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  2. Nutritional status assessment

    Nutritional status was assessed using the "Patient generated subjective global assessment" (PG-SGA) tool.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  3. 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.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  4. 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.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  5. 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.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  6. 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.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  7. Quality of life assessment

    Quality of life was assessed using EORTC QLQ questionnaires.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  8. Symptom burden assessment

    Symptom burden was assessed using the validated Memorial Symptom Assessment Survey.

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  9. Hospitalization

    We recorded whether the participant was hospitalized or not.

    Measured: Throughout the 8.5 weeks of intervention

  10. Number of hospitalizations

    If the participant was hospitalized, we recorded the number of hospitalizations

    Measured: Throughout the 8.5 weeks of intervention

  11. Duration of hospitalization

    If the participant was hospitalized, we recorded the duration of each hospitalization

    Measured: Throughout the 8.5 weeks of intervention

  12. Weight loss

    We recorded whether the participant had weight loss or not

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  13. Amount and span of weight loss

    If the participant had weight loss, we recorded how much he had lost and during what time span

    Measured: Throughout 16.5 week study period (from baseline till the end of study)

  14. Treatment dose reduction

    We recorded whether there was treatment dose reduction and the reason for that.

    Measured: Throughout the 6.5 weeks of treatment

  15. Treatment break

    We recorded whether there was treatment break and the reason for that.

    Measured: Throughout the 6.5 weeks of treatment

  16. Early cessation of treatment

    We recorded whether there was early cessation of treatment and the reason for that.

    Measured: Throughout the 8.5 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start3 Feb 2020
  3. Primary completion10 Aug 2021
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04253808
Sponsor's protocol ID
19635
Acronym
CRHF
Status last verified
Oct 2021
First submitted
15 Jan 2020
Last updated
5 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Publications

  • 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.

    PubMed 29604042

  • Taha HM, Holscher HD, Atrash F, Slade AN, Maino Vieytes CA, Pan YX, Arthur AE. Medically Tailored Meals During Radiotherapy for Head and Neck Cancer: A Pilot Randomized Controlled Trial. Nutr Cancer. 2026;78(3):233-246. doi: 10.1080/01635581.2025.2608398. Epub 2026 Jan 16.

    PubMed 41542842

Questions about this trial

What is this clinical trial studying?

A study testing Carbohydrate-restricted, high-fat diet and Regular composition diet in people with Head and Neck Squamous Cell Carcinoma, run by University of Illinois at Urbana-Champaign at 1 site in Palestinian Territories.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility measure: Recruitment (time frame: Through study completion, an average of 2 years). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04253808, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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