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

July 8, 2026 updated by: Institut Curie
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Avignon, France, 84000
        • 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 Leon Berard
        • Contact:
          • Pamela FUNK DEBLEDS, MD
        • Principal Investigator:
          • Pamela FUNK DEBLEDS
      • Lyon, France, 69004
        • 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, 51092
        • Recruiting
        • CHU Reims
        • Principal Investigator:
          • Olivier BOUCHE, MD
        • Contact:
          • Olivier BOUCHE, MD
      • Reims, France, 51100
        • Withdrawn
        • Institut Jean Godinot
      • Rennes, France
        • Withdrawn
        • Centre Eugene Marquis
      • Saint-Cloud, France, 92210
        • Recruiting
        • Institut Curie
        • Contact:
          • Lucie GENTILHOMME, MD
        • Principal Investigator:
          • Lucie GENTILHOMME, MD
      • Saint-Herblain, France, 44805
        • Withdrawn
        • Institut de Cancérologie de l'Ouest (ICO)
      • Suresnes, France, 92150
        • Withdrawn
        • Hôpital Foch
      • Villejuif, France, 94800
        • Not yet recruiting
        • Hôpital Paul Brousse
        • Contact:
          • Cindy NEUZILLET
    • Institut Curie
      • Tours, Institut Curie, France, 37044
        • Recruiting
        • CHRU de Tours
        • Principal Investigator:
          • Thierry LECOMTE, MD
        • Contact:
          • Thierry LECOMTE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program
Time Frame: 8 weeks

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cindy NEUZILLET, MD, Hôpital Paul Brousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings