Informations générales (source: ClinicalTrials.gov)
ProActIF-01 Trial: Randomized Study of Evaluation of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Lung or Digestive Cancers (ProActIF-01)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
avril 2023
octobre 2026
29 juin 2024
The ProActIF-01 trial aims to assess the efficacy of a supervised 8-week combined APA and
nutrition individualized program on survival without HRQoL deterioration (European
Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire,
EORTC QLQ-C30, 1 targeted dimension), in advanced lung or 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 | 04/09/2024 13:49:41 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | 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 | Jennifer ARRONDEAU, MD | 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 | Julien EDELINE, MD | 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) | ||||
| Hôpital de la Croix Rousse - Hospices Civils de Lyon - 69004 - Lyon - France | Nicolas BENECH, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Sophie MORIN, MD | Contact (sur clinicalTrials) | |||
| Institut Daniel Hollard - Groupe Hospitalier Mutualiste - 38000 - Grenoble - France | Camille HERVE, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest (ICO) - 44805 - Saint-herblain - France | Damien VANSTENNE, MD | Contact (sur clinicalTrials) | |||
| Institut du Cancer de Montpellier (ICM) - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51100 - Reims - France | Gianfilippo NIFOSI, MD | 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 lung or
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 lung or
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/small cell lung 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. One or more major criteria for risk of refeeding syndrome: weight loss >15% in 3-6
months or BMI <16 kg/m2 or no nutritional intake for > 10 days 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).
6. Pregnancy or breastfeeding.
7. Protected adults (individuals under guardianship by court order).