NCT05441163 ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
| NCT ID | NCT05441163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Curie |
| Condition | CANCER |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-04-08 |
| Primary Completion | 2028-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-04-08 with a primary completion date of 2028-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria: 1. Signed and dated informed consent. 2. Age ≥ 18 years (no superior limit), men and women. 3. First-line treatment (chemotherapy and/or immunotherapy) for advanced disease (previous adjuvant therapy allowed). 4. Histologically confirmed adenocarcinoma or squamous cell carcinoma of digestive tract (colorectal, esogastric, pancreas, biliary tract). 5. Locally advanced or metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed). 6. ECOG PS 0-2. Note: patient with ECOG PS 3-4 are excluded because they are usually not eligible for chemotherapy. 7. 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). 8. Life expectancy ≥ 8 weeks. 9. Able to answer questionnaires in French. 10. Availability of an APA partner (family member or friend who will attend the exercise sessions at least once a week). 11. Registration in a national health care system (Couverture Maladie Universelle, CMU included). Exclusion Criteria: 1. Neuroendocrine carcinoma histology. 2. 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. 3. 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). 4. 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. 5. 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. 6. Pregnancy or breastfeeding. 7. Protected adults (individuals under guardianship by court order).
Contact & Investigator
Cindy NEUZILLET, MD
PRINCIPAL INVESTIGATOR
Hôpital Paul Brousse
Frequently Asked Questions
Who can join the NCT05441163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CANCER. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05441163 currently recruiting?
Yes, NCT05441163 is actively recruiting participants. Contact the research team at anne-sophie.plissonnier@curie.fr for enrollment information.
Where is the NCT05441163 trial being conducted?
This trial is being conducted at Tours, France, Avignon, France, Bordeaux, France, Clermont-Ferrand, France and 11 additional locations.
Who is sponsoring the NCT05441163 clinical trial?
NCT05441163 is sponsored by Institut Curie. The principal investigator is Cindy NEUZILLET, MD at Hôpital Paul Brousse. The trial plans to enroll 50 participants.
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