Chimiodiet Study:Impact of Early and Active Nutritional and Dietary Management on grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 15
- 主要终点
- Toxicities frequently associated with chemotherapy
研究概览
简要总结
Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist will be assigned to each research centre. She will cover active nutritional support during a one-hour consultation and assist the investigating oncologist in filling out the e-CRF data. A two-day meeting prior to the beginning of the study will enable the standardization of active nutritional support strategy across all research centres:
- The nutritionist will explain the consequences of the side effects of chemotherapy on appetite levels and nutritional status.
- Spontaneous oral intake and eating habits will be assessed based on a qualitative and quantitative 3-day food record.
- Then the nutritionist will explain to patients how to adapt their diet (fortification, portion control etc.) according to personal preferences and dietary habits, appetite fluctuation and side effects.
- A booklet containing an overview of the nutritional counsel, recipe ideas, an example of a daily menu, energy equivalence tables and specific diet and hygiene tips for each possible side effects of chemotherapy will be given to all patients.
- During each consultation, patients will be weighed, appetite and food intake will be evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12, V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional counsel will be adapted to each patient's individual situation. In case of decrease in food intake and/or weight loss, a protein- and energy-rich oral supplement will be given.
In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month period or > 10% in total) and/or food intake less than 50% of estimated daily requirements, an oral supplement will be given after approval of the oncologist. If this measure is insufficient, artificial nutrition (enteral or parenteral) will be considered.
详细描述
The "Nutricancer study" carried out on 2,000 French patients showed a malnutrition prevalence rate of 39% in cancer patients. Malnutrition is an independent risk factor for hospital-acquired infections. It also increases the complication rate following surgery, chemotherapy and radiotherapy. It may require a reduction in chemotherapy dosage, thus decreasing the effectiveness of treatment. It increases the length of hospital stays and the cost of care, and has a negative impact on the quality of life of patients (2, 3). Nutritional management is not sufficient. Close to 60% of patients included in the Nutricancer study reported that they had received no nutritional support. Yet, the benefits of nutritional support in perioperative care for surgical colorectal cancers is well established. A recent study suggests that early and active nutritional support in rectal cancer patients reduces the risk of malnutrition, complications from radiotherapy and increases the quality of life of patients. Close to half of patients receiving FOLFOX or FOLFIRI type chemotherapies for metastatic colorectal cancer (CRC) develop a grade 3 toxicity. Our hypothesis is that active nutritional support during chemotherapy for metastatic colorectal cancer will permit the sustainability of intakes and the nutritional status of patients and lead to a reduction in complications, an improvement in quality of life and a reduction in the length of hospital stays.
The goal of our study is to show that early and active nutritional and dietary management (early nutritional support for short) during chemotherapy for metastatic colorectal cancer decreases the risk of malnutrition, reduces chemotherapy toxicity, improves quality of life and decreases the length of hospital stays.
The main evaluation criteria of the study will be the frequency of grade 3 or more toxicity in patients receiving active nutritional support during first line chemotherapy and/or targeted therapy for non surgical metastatic colorectal cancer.
Experimental framework: This is a prospective, multicentre, open, sample-based clinical trial. Patients eligible for the study must have been diagnosed with non surgical metastatic colorectal cancer and be planned to receive 5FU/oxaliplatine or 5FU/irinotecan based chemotherapy, associated or not with targeted therapy. The main exclusion criteria are severe malnutrition, adjuvant radiotherapy, artificial nutrition, pregnancy and breastfeeding, another severe active disease and participation in another clinical trial.
The ChimioDiet study will be proposed during the consultation meant to set up chemotherapy. Selected patients will be randomly assigned to two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Over 18 years of age
- •Patients with synchrone or metachronous CRC metastases without possible initial surgical outcome
- •Patients covered by Social Security
- •Patients willing to sign the proper consent forms
排除标准
- •Severely malnourished patients according to the Authority for Health criteria : weight loss > 5% of base weight in less than one month or > 10% of base weight in less than six months and/or BMI < 18 or 21.5 in patients 70 years old or more, and/or serum albumin assay < 35 g/l.
- •Patients receiving concomitant radiotherapy.
- •Patients receiving or programmed to receive artificial nutrition (enteral or parenteral).
- •Pregnant or breastfeeding women (a qualitative urine pregnancy test will be given to all women of child-bearing age).
- •Patients incapable of understanding (foreign language, intellectual deficiencies, motor cortex deficiencies...) and/or applying the nutritional counselling (persons institutionalised in a rest home, retirement home, prison etc.).
- •Patients with another sever debilitating disease likely to impact on nutritional status (cardiac, hepatic, or renal insufficiency etc.).
- •Persons already participating in another clinical trial.
结局指标
主要结局
Toxicities frequently associated with chemotherapy
时间窗: 2 weeks
Number and grade of: diarrhoea,nausea,vomiting, oral mucositis,fatigue, neurotoxicities, dysgeusia,haematological toxicities such as leukopenia neutropenia,anemia and thrombocytopenia.
次要结局
- The number of hospital days(All study)
- Number of occurrences of grades 1 and 2 toxicities(2 weeks)
- Nutritional status of patients(2 weeks)
- Overall survival(All study)
- Appetite measures(2 weeks)
- Quality of life(3 months)