ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers

Обзор

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.

Вмешательства

• Другое APA and nutrition intervention
  \- APA intervention: weekly supervised sessions at home with the APA professional combined with unsupervised sessions, alone or with the APA partner, for 8 weeks. The supervised session will be broken down as follows: warm-up block (approximately 10'), aerobic block (15'), muscle strengthening/resistance block (15') and stretching/relaxation block (10'). The remaining 10' will be used to review the session and the individual sessions. This program can be adapted to the needs and abilities of th

Первичные конечные точки

• Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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).
• ECOG PS 0-2. 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 18 центров

• CHRU de Tours — Tours
• Institut du cancer Avignon-Provence — Avignon
• Institut Bergonié — Bordeaux
• Centre de Lutte Contre le Cancer Jean Perrin — Clermont-Ferrand
• Institut Daniel Hollard - Groupe Hospitalier Mutualiste — Grenoble
• centre Oscar Lambret — Lille
• Hôpital de la Croix Rousse - Hospices Civils de Lyon — Lyon
• centre Léon Bérard — Lyon
• … и ещё 10 центров

Идентификаторы

NCT: NCT05441163 · IC 2021-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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