ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted
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.
| Condition(s) | CANCER |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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% |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Institut Curie |
| Locations | Tours, Institut Curie, France; Avignon, France; Bordeaux, France; Clermont-Ferrand, France; Grenoble, France; Lille, France (+11 more sites) |
| Start date | 2023-04-08 |
| NCT ID | NCT05441163 |
| Official listing | https://clinicaltrials.gov/study/NCT05441163 |