Actively Recruiting
ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
Led by Institut Curie · Updated on 2025-06-24
50
Participants Needed
17
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent.
- Age 18 years or older, men and women.
- Undergoing first-line chemotherapy and/or immunotherapy for advanced disease (previous adjuvant therapy allowed).
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the digestive tract (colorectal, esogastric, pancreas, biliary tract).
- Locally advanced or metastatic disease not suitable for curative surgery, radiation, or combined therapy (previous primary tumor resection allowed).
- ECOG Performance Status 0-2.
- At least one risk factor: ECOG PS 2 and/or malnutrition (weight loss ≥5% in 1 month or ≥10% in 6 months or BMI <18.5 kg/m2 for patients under 70 years, BMI <22 for those 70 or older).
- Life expectancy of at least 8 weeks.
- Able to answer questionnaires in French.
- Have an APA partner (family member or friend) attending exercise sessions at least weekly.
- Registered in a national health care system (including Couverture Maladie Universelle).
You will not qualify if you...
- Neuroendocrine carcinoma histology.
- Any medical condition (including psychiatric, musculoskeletal, or neurological) that prevents exercise.
- Nonfunctional gastrointestinal tract compromising oral or enteral feeding (unless bypass or stent is possible).
- Participation in another physical activity or nutritional structured program within the past two months.
- Major risk of refeeding syndrome (BMI <16 kg/m2 or low potassium, phosphorus, magnesium before refeeding).
- Pregnancy or breastfeeding.
- Under legal guardianship by court order.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
CHRU de Tours
Tours, Institut Curie, France, 37044
Not Yet Recruiting
2
Institut du cancer Avignon-Provence
Avignon, France, 84000
Not Yet Recruiting
3
Institut Bergonié
Bordeaux, France, 33076
Withdrawn
4
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
5
Institut Daniel Hollard - Groupe Hospitalier Mutualiste
Grenoble, France, 38000
Withdrawn
6
centre Oscar Lambret
Lille, France, 59020
Withdrawn
7
Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, France, 69004
Not Yet Recruiting
8
centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
9
Institut du Cancer de Montpellier (ICM)
Montpellier, France, 34298
Withdrawn
10
Institut Curie
Paris, France, 75005
Actively Recruiting
11
Hôpital COCHIN AP-HP
Paris, France, 75014
Withdrawn
12
CHU Reims
Reims, France, 51092
Not Yet Recruiting
13
Institut Jean Godinot
Reims, France, 51100
Withdrawn
14
Centre Eugène Marquis
Rennes, France
Withdrawn
15
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
16
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, France, 44805
Withdrawn
17
Hôpital Foch
Suresnes, France, 92150
Withdrawn
Research Team
A
Anne-Sophie PLISSONNIER
CONTACT
C
Cindy NEUZILLET, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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