ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers

NCT05441163 | Recruiting

• 1 other identifier: IC 2021-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

CANCER

Keywords

gastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program

  The rate of eligible and evaluable patients who complete successfully the nutrition and APA program. For a given patient, the success of the program is defined by: * at least 75% of the planned supervised APA sessions: 6 of 8 home-based sessions with an APA professional * at least 75% of the nutritional evaluations: 6 of 8 planned home-based evaluations.

  8 weeks

Study Arms (1)

APA and nutrition program

EXPERIMENTAL

Other: APA and nutrition intervention

Interventions

APA and nutrition intervention OTHER

\- 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.

APA and nutrition program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Age ≥ 18 years (no superior limit), men and women.
• First-line treatment (chemotherapy and/or immunotherapy) for advanced disease (previous adjuvant therapy allowed).
• Histologically confirmed adenocarcinoma or squamous cell carcinoma of digestive tract (colorectal, esogastric, pancreas, biliary tract).
• Locally advanced or metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed).
• ECOG PS 0-2. Note: patient with ECOG PS 3-4 are excluded because they are usually not eligible for chemotherapy.
• 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).
• Life expectancy ≥ 8 weeks.
• Able to answer questionnaires in French.
• Availability of an APA partner (family member or friend who will attend the exercise sessions at least once a week).
• Registration in a national health care system (Couverture Maladie Universelle, CMU included).

You may not qualify if:

• Neuroendocrine carcinoma histology.
• Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice.
• 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).
• 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.
• 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.
• Pregnancy or breastfeeding.
• Protected adults (individuals under guardianship by court order).

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (17)

CHRU de Tours

Tours, Institut Curie, 37044, France

NOT YET RECRUITING

Institut du cancer Avignon-Provence

Avignon, 84000, France

NOT YET RECRUITING

Institut Bergonié

Bordeaux, 33076, France

WITHDRAWN

Centre de Lutte Contre le Cancer Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

Institut Daniel Hollard - Groupe Hospitalier Mutualiste

Grenoble, 38000, France

WITHDRAWN

centre Oscar Lambret

Lille, 59020, France

WITHDRAWN

Hôpital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

NOT YET RECRUITING

centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut du Cancer de Montpellier (ICM)

Montpellier, 34298, France

WITHDRAWN

Institut Curie

Paris, 75005, France

RECRUITING

Hôpital COCHIN AP-HP

Paris, 75014, France

WITHDRAWN

CHU Reims

Reims, 51092, France

NOT YET RECRUITING

Institut Jean Godinot

Reims, 51100, France

WITHDRAWN

Centre Eugène Marquis

Rennes, France

WITHDRAWN

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

Institut de Cancérologie de l'Ouest (ICO)

Saint-Herblain, 44805, France

WITHDRAWN

Hôpital Foch

Suresnes, 92150, France

WITHDRAWN

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms

Interventions

Glutamyl Aminopeptidase; Diet Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Aminopeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases; Nutrition Therapy; Therapeutics

Study Officials

• Cindy NEUZILLET, MD

  Institut Curie Saint-Cloud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie PLISSONNIER

CONTACT

0033147112378; anne-sophie.plissonnier@curie.fr

Cindy NEUZILLET, MD

CONTACT

cindy.neuzillet@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention : standard of care plus a supervised 8-week combined APA and nutrition individualized program

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: April 8, 2023
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): April 8, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (17)