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
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-04-08
2028-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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APA and nutrition program
APA and nutrition intervention
\- APA intervention: weekly supervised sessions at home with the APA professional combined with unsupervised sessions, alone or with the APA partner, for 8 weeks.
The supervised session will be broken down as follows: warm-up block (approximately 10'), aerobic block (15'), muscle strengthening/resistance block (15') and stretching/relaxation block (10'). The remaining 10' will be used to review the session and the individual sessions. This program can be adapted to the needs and abilities of the patient if necessary.
\- Nutritional intervention: dietitian weekly visits at home during 8 weeks with dietetic counseling; decision of oral, enteral and/or parenteral feeding validated by the clinical steering committee according to the Société Francophone de Nutrition Clinique et Métabolisme (SFNCM) guidelines.
Interventions
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APA and nutrition intervention
\- APA intervention: weekly supervised sessions at home with the APA professional combined with unsupervised sessions, alone or with the APA partner, for 8 weeks.
The supervised session will be broken down as follows: warm-up block (approximately 10'), aerobic block (15'), muscle strengthening/resistance block (15') and stretching/relaxation block (10'). The remaining 10' will be used to review the session and the individual sessions. This program can be adapted to the needs and abilities of the patient if necessary.
\- Nutritional intervention: dietitian weekly visits at home during 8 weeks with dietetic counseling; decision of oral, enteral and/or parenteral feeding validated by the clinical steering committee according to the Société Francophone de Nutrition Clinique et Métabolisme (SFNCM) guidelines.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Cindy NEUZILLET, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie Saint-Cloud
Locations
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CHRU de Tours
Tours, Institut Curie, France
Institut du cancer Avignon-Provence
Avignon, , France
Institut Bergonié
Bordeaux, , France
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, , France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste
Grenoble, , France
centre Oscar Lambret
Lille, , France
Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, , France
centre Léon Bérard
Lyon, , France
Institut du Cancer de Montpellier (ICM)
Montpellier, , France
Institut Curie
Paris, , France
Hôpital COCHIN AP-HP
Paris, , France
CHU Reims
Reims, , France
Institut Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Institut Curie
Saint-Cloud, , France
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, , France
Hôpital Foch
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Thierry LECOMTE, MD
Role: primary
May MABRO, MD
Role: primary
Florence OSAER-POLYCARPE, MD
Role: primary
Mélissa GRUNER, MD
Role: primary
Pamela FUNK DEBLEDS, MD
Role: primary
Timothée MARCHAL, MD
Role: primary
Olivier BOUCHE, MD
Role: primary
Cindy NEUZILLET, MD
Role: primary
Other Identifiers
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IC 2021-01
Identifier Type: -
Identifier Source: org_study_id
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