Feasibility of a Carbohydrate-restricted, High-fat Diet to Improve Outcomes in Head and Neck Squamous Cell Carcinoma: A Pilot Randomized Controlled Feeding Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Feasibility measure: Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded from the group they are assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Karnofsky Index of ≥70 %
- •Normal liver and kidney function tests
- •Able to understand and willingly sign a written informed consent document
- •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
排除标准
- •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
- •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
结局指标
主要结局
Feasibility measure: Adherence
时间窗: 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.
Feasibility measure: Retention
时间窗: 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.
Complete blood count (CBC)
时间窗: Throughout the 8.5 weeks of intervention
CBC levels were measured, recorded, and mentioned whether levels were normal, low, or high.
Kidney function
时间窗: 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.
Phosphorus level was measured, recorded, and mentioned whether the level was normal, low, or high.
时间窗: Throughout the 8.5 weeks of intervention
Phosphorus
Chloride
时间窗: Throughout the 8.5 weeks of intervention
Chloride level was measured, recorded, and mentioned whether the level was normal, low, or high.
Potassium
时间窗: Throughout the 8.5 weeks of intervention
Potassium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Magnesium
时间窗: Throughout the 8.5 weeks of intervention
Magnesium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Calcium
时间窗: Throughout the 8.5 weeks of intervention
Calcium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Albumin level
时间窗: 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
时间窗: 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.
Blood Glucose
时间窗: Throughout the 8.5 weeks of intervention
Blood glucose level was measured, recorded, and mentioned whether the level was normal, low, or high.
Liver function
时间窗: 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.
Insulin level
时间窗: Throughout the 8.5 weeks of intervention
Insulin level was measured, recorded, and mentioned whether the level was normal, low, or high.
Sodium
时间窗: Throughout the 8.5 weeks of intervention
Sodium level was measured, recorded, and mentioned whether the level was normal, low, or high.
Total cholesterol level
时间窗: Throughout the 8.5 weeks of intervention
Total cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.
Feasibility measure: Recruitment
时间窗: 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.
HDL-cholesterol level
时间窗: Throughout the 8.5 weeks of intervention
HDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.
Total protein level
时间窗: Throughout the 8.5 weeks of intervention
Total protein level was measured, recorded, and mentioned whether the level was normal, low, or high.
Triglycerides level
时间窗: Throughout the 8.5 weeks of intervention
Triglycerides levels were measured, recorded, and mentioned whether the levels were normal, low, or high.
LDL-cholesterol level
时间窗: Throughout the 8.5 weeks of intervention
LDL-cholesterol level was measured, recorded, and mentioned whether the level was normal, low, or high.
次要结局
- Basal metabolic rate (BMR)(Throughout 16.5 week study period (from baseline till the end of study))
- Nutritional status assessment(Throughout 16.5 week study period (from baseline till the end of study))
- Hospitalization(Throughout the 8.5 weeks of intervention)
- Weight loss(Throughout 16.5 week study period (from baseline till the end of study))
- Amount and span of weight loss(Throughout 16.5 week study period (from baseline till the end of study))
- Treatment break(Throughout the 6.5 weeks of treatment)
- Tumor progression assessment(Throughout 16.5 week study period (from baseline till the end of study))
- Symptom burden assessment(Throughout 16.5 week study period (from baseline till the end of study))
- Early cessation of treatment(Throughout the 8.5 weeks of treatment)
- Percentage of body fat(Throughout 16.5 week study period (from baseline till the end of study))
- Percentage of lean body mass(Throughout 16.5 week study period (from baseline till the end of study))
- Percentage of body water(Throughout 16.5 week study period (from baseline till the end of study))
- Quality of life assessment(Throughout 16.5 week study period (from baseline till the end of study))
- Duration of hospitalization(Throughout the 8.5 weeks of intervention)
- Number of hospitalizations(Throughout the 8.5 weeks of intervention)
- Treatment dose reduction(Throughout the 6.5 weeks of treatment)
研究者
Anna Arthur
Assistant Professor
University of Illinois at Urbana-Champaign