NCT05441163招募中不适用
ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 18
- 主要终点
- Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program
研究概览
简要总结
The ProActIF-01 trial aims to assess the feasibility of a supervised 8-week combined APA and nutrition individualized program, in advanced digestive cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Signed and dated informed consent.
- •Age ≥ 18 years (no superior limit), men and women.
- •First-line treatment (chemotherapy and/or immunotherapy) for advanced disease (previous adjuvant therapy allowed).
- •Histologically confirmed adenocarcinoma or squamous cell carcinoma of digestive tract (colorectal, esogastric, pancreas, biliary tract).
- •Locally advanced or metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed).
- •Note: patient with ECOG PS 3-4 are excluded because they are usually not eligible for chemotherapy.
- •Having at least one risk factor among the following: ECOG PS = 2 and/or malnutrition (weight loss ≥5% of body weight in 1 month or ≥10% in 6 months or compared to usual weight before disease or BMI <18.5 kg/m2 for patients aged <70 years and 22 for patients aged ≥70 years).
- •Life expectancy ≥ 8 weeks.
- •Able to answer questionnaires in French.
- •Availability of an APA partner (family member or friend who will attend the exercise sessions at least once a week).
- •Registration in a national health care system (Couverture Maladie Universelle, CMU included).
排除标准
- •Neuroendocrine carcinoma histology.
- •Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice.
- •Note: bone or brain metastases are allowed if not at risk of complications and if associated symptoms do not limit exercise practice; radiotherapy is allowed if terminated ≥ 2 weeks prior to study inclusion.
- •Nonfunctional gastrointestinal tract compromising oral/enteral feeding. Note: gastrointestinal tract obstruction is allowed if the tumor can be bypassed or stented (e.g. esophageal cancer with gastric tube-stoma or esophageal stent).
- •Participation to another physical activity or nutritional structured intervention program (in the first two months).
- •Note: participation to another concomitant clinical trial (except for trials evaluating supportive care programs involving physical activity or nutritional intervention) is allowed but the patient must inform the Investigator and get an authorization from the Sponsor.
- •Major risk of refeeding syndrome: BMI <16 kg/m2 or low blood levels of potassium, phosphorus or magnesium prior to refeeding (Note : oral and/or IV supplementation is allowed and patients can be included after correction of blood levels of potassium, phosphorus and magnesium).
- •Note : - malnourished patients who have started nutritional intervention (ONS, artificial nutrition) are eligible if they have not started chemotherapy/immunotherapy.
- •- progressive increase in calory/protein is possible in severely malnourished patients but the targets should be reached before the 2nd chemotherapy/immunotherapy cycle.
- •Pregnancy or breastfeeding.
- •Protected adults (individuals under guardianship by court order).
研究组 & 干预措施
APA and nutrition program
Experimental
干预措施: APA and nutrition intervention (Other)
结局指标
主要结局
Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program
时间窗: 8 weeks
The rate of eligible and evaluable patients who complete successfully the nutrition and APA program. For a given patient, the success of the program is defined by: * at least 75% of the planned supervised APA sessions: 6 of 8 home-based sessions with an APA professional * at least 75% of the nutritional evaluations: 6 of 8 planned home-based evaluations.
次要结局
未报告次要终点
研究者
研究点 (18)
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