Individualized nutrition and physical activity program for frail patients with advanced digestive cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ProActIF-01 trial evaluates the feasibility of an 8-week program combining adapted physical activity and individualized nutrition for patients suffering from advanced digestive cancers. This interventional study focuses on patients undergoing first-line treatment for their condition, aiming to improve their overall health and well-being. Participants will receive tailored interventions designed to address their specific needs and risk factors associated with frailty and malnutrition. The study will assess how these interventions can be integrated into the care of patients with advanced gastrointestinal cancers.

Why it matters

Who can join: the full rules

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).

Where it's running

• CHRU de Tours
  Tours, Institut Curie, France Recruiting
• Institut du cancer Avignon-Provence
  Avignon, France Recruiting
• Centre de Lutte Contre le Cancer Jean Perrin
  Clermont-Ferrand, France Recruiting
• Hôpital de la Croix Rousse - Hospices Civils de Lyon
  Lyon, France Recruiting
• centre Léon Bérard
  Lyon, France Recruiting
• Institut Curie
  Paris, France Recruiting

Study contacts

• Principal investigator: Cindy NEUZILLET, MD — Hôpital Paul Brousse
• Study coordinator: Anne-Sophie PLISSONNIER
• Email: anne-sophie.plissonnier@curie.fr
• Phone: 0033147112378

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.