Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Adherence to the ketogenic diet
研究概览
简要总结
Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups:
- the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period
- the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment
详细描述
Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:
- The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.
- The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.
Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.
During follow-ups it will be assessed:
- BMI and body composition (by bioimpedance analysis)
- Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment)
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic confirmation of rectal adenocarcinoma
- •Locally advanced rectal cancer
- •Patients undergoing neoadjuvant radiotherapy treatment
- •Signature of informed consent to the processing of personal data
排除标准
- •Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria
- •Patients treated for palliative purposes
- •Patients with metastatic disease
- •Diabetes mellitus
- •Pregnancy or lactation
- •Significant food allergies that would make the person unable to consume the food provided
- •Refusal to participate in the proposed clinical trial
结局指标
主要结局
Adherence to the ketogenic diet
时间窗: 2 months
The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit. The patients will fill out the questionnaire and return it at future visits.
次要结局
- Evaluation of the response to the treatment(2 months)
- Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group(2 months)
- Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group(2 months)
- Evaluation of the tolerability to the treatment(2 months)
- Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response(2 months)
- Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response(2 months)
- Investigate indices of quality of life(2 months)
研究者
Mele Maria Cristina
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
