Informations générales (source: ClinicalTrials.gov)
ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers (ProActIF-01)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
avril 2023
avril 2028
18 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:10 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:56 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Lutte Contre le Cancer Jean Perrin - 63011 - Clermont-Ferrand - France | Florence OSAER-POLYCARPE, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - Rennes - France | Contact (sur clinicalTrials) | ||||
| centre Léon Bérard - 69373 - Lyon - France | Pamela FUNK DEBLEDS, MD | Contact (sur clinicalTrials) | |||
| centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHRU de Tours - 37044 - Tours - Institut Curie - France | Thierry LECOMTE, MD | Contact (sur clinicalTrials) | |||
| CHU Reims - 51092 - Reims - France | Olivier BOUCHE, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - Hospices Civils de Lyon - 69004 - Lyon - France | Nicolas BENECH, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Daniel Hollard - Groupe Hospitalier Mutualiste - 38000 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest (ICO) - 44805 - Saint-herblain - France | Contact (sur clinicalTrials) | ||||
| Institut du cancer Avignon-Provence - 84000 - Avignon - France | May MABRO, MD | Contact (sur clinicalTrials) | |||
| Institut du Cancer de Montpellier (ICM) - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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).
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).
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).