Clinical trial NCT05441163: ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
Official title: ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CANCER
Keywords: gastrointestinal cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention : standard of care plus a supervised 8-week combined APA and nutrition individualized program
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
state: Institut Curie
city: Avignon
country: France
facility: Institut du cancer Avignon-Provence
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean Perrin
city: Grenoble
country: France
facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste
city: Lille
country: France
facility: centre Oscar Lambret
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - Hospices Civils de Lyon
city: Lyon
country: France
facility: centre Léon Bérard
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier (ICM)
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital COCHIN AP-HP
city: Reims
country: France
facility: CHU Reims
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-herblain
country: France
facility: Institut de Cancérologie de l'Ouest (ICO)
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Institut Curie Saint-Cloud
name: Cindy NEUZILLET, MD
role: PRINCIPAL_INVESTIGATOR
References: