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Personalized nutrition and exercise program aims to boost strength in frail cancer patients

NCT ID NCT05441163

Symptom relief Sponsor: Institut Curie Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether an 8-week program combining personalized nutrition advice and supervised home-based exercise is feasible for frail patients with advanced digestive cancers. Participants receive weekly visits from an exercise professional and dietitian, along with unsupervised sessions. The goal is to see if patients can stick with the program, potentially improving their strength and well-being during cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
personalized nutrition and adapted physical activity program
What this could lead to
If successful, this program could help frail cancer patients maintain strength and quality of life during treatment.
What could go wrong
This is a small feasibility study, so results may not apply to all patients. The program requires significant commitment and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

cancer digestive system cancer digestive system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU de Tours

    RECRUITING

    Tours, Institut Curie, 37044, France

  • CHU Reims

    RECRUITING

    Reims, 51092, France

  • Centre Eugène Marquis

    WITHDRAWN

    Rennes, France

  • Centre de Lutte Contre le Cancer Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Hôpital COCHIN AP-HP

    WITHDRAWN

    Paris, 75014, France

  • Hôpital Foch

    WITHDRAWN

    Suresnes, 92150, France

  • Hôpital Paul Brousse

    NOT_YET_RECRUITING

    Villejuif, 94800, France

  • Hôpital de la Croix Rousse - Hospices Civils de Lyon

    RECRUITING

    Lyon, 69004, France

  • Institut Bergonié

    WITHDRAWN

    Bordeaux, 33076, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Curie

    RECRUITING

    Saint-Cloud, 92210, France

  • Institut Daniel Hollard - Groupe Hospitalier Mutualiste

    WITHDRAWN

    Grenoble, 38000, France

  • Institut Jean Godinot

    WITHDRAWN

    Reims, 51100, France

  • Institut de Cancérologie de l'Ouest (ICO)

    WITHDRAWN

    Saint-Herblain, 44805, France

  • Institut du Cancer de Montpellier (ICM)

    WITHDRAWN

    Montpellier, 34298, France

  • Institut du cancer Avignon-Provence

    RECRUITING

    Avignon, 84000, France

  • centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • centre Oscar Lambret

    WITHDRAWN

    Lille, 59020, France

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