Status:
RECRUITING
ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
Lead Sponsor:
Institut Curie
Conditions:
CANCER
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
April 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05441163
Start Date
April 8 2023
End Date
April 8 2028
Last Update
June 24 2025
Active Locations (17)
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1
CHRU de Tours
Tours, Institut Curie, France, 37044
2
Institut du cancer Avignon-Provence
Avignon, France, 84000
3
Institut Bergonié
Bordeaux, France, 33076
4
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, France, 63011