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

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

NA · Institut Curie · NCT05441163

This study tests whether an 8-week program of personalized nutrition and exercise can help frail patients with advanced digestive cancers feel better during their first treatment.

Quick facts

PhaseNA
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut Curie (other)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations17 sites (Tours, Institut Curie and 16 other locations)
Trial IDNCT05441163 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced digestive cancers who are undergoing first-line treatment and exhibit signs of frailty or malnutrition.

Not a fit: Patients with ECOG performance status of 3-4, indicating severe functional impairment, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this program could enhance the quality of life and treatment outcomes for patients with advanced digestive cancers.

How similar studies have performed: While similar approaches have been explored, this specific combination of individualized nutrition and adapted physical activity in this patient population is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tours, Institut Curie and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: CANCER, gastrointestinal cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.