Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
non-metastatic
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.
Interventions
BEHAVIORALCarbohydrate-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.
BEHAVIORALRegular composition diet
The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins
Sponsors
Augusta Victoria Hospital, East Jerusalem
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants will be blinded from the group they are assigned to.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDL-cholesterol level | Throughout the 8.5 weeks of intervention | HDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Feasibility measure: Retention | Throughout 16.5 week study period (from baseline till the end of study) | Retention will be measured by recording the number of patients included or agreed to participate and completed all study protocol. |
| Blood Glucose | Throughout the 8.5 weeks of intervention | Blood glucose level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Complete blood count (CBC) | Throughout the 8.5 weeks of intervention | CBC levels were measured, recorded, and mentioned whether levels were normal, low, or high. |
| Liver function | Throughout the 8.5 weeks of intervention | 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. |
| Kidney function | Throughout the 8.5 weeks of intervention | 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. |
| Potassium | Throughout the 8.5 weeks of intervention | Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Sodium | Throughout the 8.5 weeks of intervention | Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Chloride | Throughout the 8.5 weeks of intervention | Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Calcium | Throughout the 8.5 weeks of intervention | Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Albumin level | Throughout the 8.5 weeks of intervention | Albumin level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| C-reactive protein (CRP) level | Throughout the 8.5 weeks of intervention | CRP level was measured, recorded, and mentioned whether the level was normal, low, or high. High level indicates inflammation. |
| Total protein level | Throughout the 8.5 weeks of intervention | Total protein level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Insulin level | Throughout the 8.5 weeks of intervention | Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Triglycerides level | Throughout the 8.5 weeks of intervention | Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high. |
| Total cholesterol level | Throughout the 8.5 weeks of intervention | Total cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| LDL-cholesterol level | Throughout the 8.5 weeks of intervention | LDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high. | Throughout the 8.5 weeks of intervention | Phosphorus |
| Magnesium | Throughout the 8.5 weeks of intervention | Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high. |
| Feasibility measure: Recruitment | Through study completion, an average of 2 years | Recruitment will be measured by recording the number of patients screened, included, excluded, dropped-out, and completed the study throughout the study period. |
| Feasibility measure: Adherence | Throughout the 16.5 week study period (from baseline till the end of study) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status assessment | Throughout 16.5 week study period (from baseline till the end of study) | Nutritional status was assessed using the Patient generated subjective global assessment (PG-SGA) tool. |
| Percentage of body fat | Throughout 16.5 week study period (from baseline till the end of study) | 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. |
| Percentage of lean body mass | Throughout 16.5 week study period (from baseline till the end of study) | 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. |
| Percentage of body water | Throughout 16.5 week study period (from baseline till the end of study) | 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. |
| Basal metabolic rate (BMR) | Throughout 16.5 week study period (from baseline till the end of study) | BMR was measured by using a Bioelectric Impedance Analysis (BIA) device and used to study the effect of the intervention on body composition. |
| Quality of life assessment | Throughout 16.5 week study period (from baseline till the end of study) | Quality of life was assessed using EORTC QLQ questionnaires. |
| Symptom burden assessment | Throughout 16.5 week study period (from baseline till the end of study) | Symptom burden was assessed using the validated Memorial Symptom Assessment Survey. |
| Hospitalization | Throughout the 8.5 weeks of intervention | We recorded whether the participant was hospitalized or not. |
| Number of hospitalizations | Throughout the 8.5 weeks of intervention | If the participant was hospitalized, we recorded the number of hospitalizations |
| Duration of hospitalization | Throughout the 8.5 weeks of intervention | If the participant was hospitalized, we recorded the duration of each hospitalization |
| Weight loss | Throughout 16.5 week study period (from baseline till the end of study) | We recorded whether the participant had weight loss or not |
| Amount and span of weight loss | Throughout 16.5 week study period (from baseline till the end of study) | If the participant had weight loss, we recorded how much he had lost and during what time span |
| Treatment dose reduction | Throughout the 6.5 weeks of treatment | We recorded whether there was treatment dose reduction and the reason for that. |
| Treatment break | Throughout the 6.5 weeks of treatment | We recorded whether there was treatment break and the reason for that. |
| Early cessation of treatment | Throughout the 8.5 weeks of treatment | We recorded whether there was early cessation of treatment and the reason for that. |
| Tumor progression assessment | Throughout 16.5 week study period (from baseline till the end of study) | Tumor progression was assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging. |
Countries
Palestinian Territories
Outcome results
None listed