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

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.

Study Overview

• Status: Recruiting
• Conditions: CANCER
• Intervention / Treatment: Other: APA and nutrition intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cindy NEUZILLET, MD; Email: cindy.neuzillet@curie.fr
• Study Contact Backup: Name: Anne-Sophie PLISSONNIER; Phone Number: 0033147112378; Email: anne-sophie.plissonnier@curie.fr

Study Locations

• France
  • Avignon, France, 84000
    • Not yet recruiting
    • Institut du Cancer Avignon-Provence
    • Contact: May MABRO, MD
    • Principal Investigator: May MABRO, MD
  • Bordeaux, France, 33076
    • Withdrawn
    • Institut Bergonie
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre de Lutte Contre le Cancer Jean PERRIN
    • Contact: Florence OSAER-POLYCARPE, MD
    • Principal Investigator: Florence OSAER-POLYCARPE
  • Grenoble, France, 38000
    • Withdrawn
    • Institut Daniel Hollard - Groupe Hospitalier Mutualiste
  • Lille, France, 59020
    • Withdrawn
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard
    • Contact: Pamela FUNK DEBLEDS, MD
    • Principal Investigator: Pamela FUNK DEBLEDS
  • Lyon, France, 69004
    • Not yet recruiting
    • Hôpital de la croix Rousse - Hospices Civils de Lyon
    • Contact: Mélissa GRUNER, MD
    • Principal Investigator: Mélissa Gruner, MD
  • Montpellier, France, 34298
    • Withdrawn
    • Institut du Cancer de Montpellier (ICM)
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Timothée MARCHAL, MD
    • Principal Investigator: Timothée MARCHAL, MD
  • Paris, France, 75014
    • Withdrawn
    • Hôpital COCHIN AP-HP
  • Reims, France, 51100
    • Withdrawn
    • Institut Jean Godinot
  • Reims, France, 51092
    • Not yet recruiting
    • Chu Reims
    • Principal Investigator: Olivier Bouche, MD
    • Contact: Olivier BOUCHE, MD
  • Rennes, France
    • Withdrawn
    • Centre Eugene Marquis
  • Saint-Cloud, France, 92210
    • Recruiting
    • Institut Curie
    • Principal Investigator: Cindy NEUZILLET, MD
    • Contact: Cindy NEUZILLET, MD
  • Saint-herblain, France, 44805
    • Withdrawn
    • Institut de Cancérologie de l'Ouest (ICO)
  • Suresnes, France, 92150
    • Withdrawn
    • Hopital Foch
  • Institut Curie
    • Tours, Institut Curie, France, 37044
      • Not yet recruiting
      • CHRU de Tours
      • Principal Investigator: Thierry LECOMTE, MD
      • Contact: Thierry LECOMTE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: APA and nutrition program

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Cindy NEUZILLET, MD, Institut Curie Saint-Cloud

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2023
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): April 8, 2028

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: gastrointestinal cancer
• Other Study ID Numbers: IC 2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No