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CANCERProActIF-01NCT05441163

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

A study testing APA and nutrition intervention in people with CANCER, run by Institut Curie at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CANCER
What is being tested?
APA and nutrition intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
18 sitesFrance
Study dates
8 Apr 2023to 7 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • Neuroendocrine carcinoma histology.
  • 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.
  • 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.
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  • 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).

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Sophie PLISSONNIER contact

0033147112378

anne-sophie.plissonnier@curie.fr

Cindy NEUZILLET, MD contact

cindy.neuzillet@aphp.fr

18 sites in 1 country

France18 sites, 9 recruiting

  • Institut du cancer Avignon-Provence

    Avignon, 84000

    May MABRO, MD

    May MABRO, MD

    Recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Withdrawn

  • Centre de Lutte Contre le Cancer Jean Perrin

    Clermont-Ferrand, 63011

    Florence OSAER-POLYCARPE, MD

    Florence OSAER-POLYCARPE

    Recruiting

  • Institut Daniel Hollard - Groupe Hospitalier Mutualiste

    Grenoble, 38000

    Withdrawn

  • centre Oscar Lambret

    Lille, 59020

    Withdrawn

  • Hôpital de la Croix Rousse - Hospices Civils de Lyon

    Lyon, 69004

    Mélissa GRUNER, MD

    Mélissa Gruner, MD

    Recruiting

  • centre Léon Bérard

    Lyon, 69373

    Pamela FUNK DEBLEDS, MD

    Pamela FUNK DEBLEDS

    Recruiting

  • Institut du Cancer de Montpellier (ICM)

    Montpellier, 34298

    Withdrawn

  • Institut Curie

    Paris, 75005

    Timothée MARCHAL, MD

    Timothée MARCHAL, MD

    Recruiting

  • Hôpital COCHIN AP-HP

    Paris, 75014

    Withdrawn

  • CHU Reims

    Reims, 51092

    Olivier BOUCHE, MD

    Olivier BOUCHE, MD

    Recruiting

  • Institut Jean Godinot

    Reims, 51100

    Withdrawn

  • Centre Eugène Marquis

    Rennes

    Withdrawn

  • Institut Curie

    Saint-Cloud, 92210

    Lucie GENTILHOMME, MD

    Lucie GENTILHOMME, MD

    Recruiting

  • Institut de Cancérologie de l'Ouest (ICO)

    Saint-Herblain, 44805

    Withdrawn

  • Hôpital Foch

    Suresnes, 92150

    Withdrawn

  • CHRU de Tours

    Tours, Institut Curie, 37044

    Thierry LECOMTE, MD

    Thierry LECOMTE, MD

    Recruiting

  • Hôpital Paul Brousse

    Villejuif, 94800

    Cindy NEUZILLET

    Not yet recruiting

Other trials in France

About this study

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
Being tested
APA and nutrition intervention
Keywords
gastrointestinal cancer
Medical subject headings
Neoplasms, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APA and nutrition interventionOther

    • 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.
Study groups in NCT05441163
Study groupRoleWhat they receive
APA and nutrition programExperimentalNot described
Receives: Other: APA and nutrition intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start8 Apr 2023
  3. Primary completion7 Oct 2028 (estimated)
  4. Study completion7 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention : standard of care plus a supervised 8-week combined APA and nutrition individualized program
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05441163
Sponsor's protocol ID
IC 2021-01
Acronym
ProActIF-01
Status last verified
Jul 2026
First submitted
28 Jun 2022
Last updated
9 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A study testing APA and nutrition intervention in people with CANCER, run by Institut Curie at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne-Sophie PLISSONNIER (0033147112378, anne-sophie.plissonnier@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05441163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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