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

Not Applicable

Recruiting

• Conditions: CANCER
• Interventions: Other: APA and nutrition intervention

• Registration Number: NCT05441163
• Lead Sponsor: Institut Curie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Study Start: 2023-04-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-02-08
• Study Completion: 2028-04-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APA and nutrition program	APA and nutrition intervention	-

Primary Outcome Measures

Name	Time	Method
Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program	8 weeks	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.

Trial Locations

Locations (16)

CHRU de Tours; 🇫🇷 Tours, Institut Curie, France

Institut du cancer Avignon-Provence; 🇫🇷 Avignon, France

CHU Reims; 🇫🇷 Reims, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre de Lutte Contre le Cancer Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Daniel Hollard - Groupe Hospitalier Mutualiste; 🇫🇷 Grenoble, France

centre Oscar Lambret; 🇫🇷 Lille, France

Hôpital de la Croix Rousse - Hospices Civils de Lyon; 🇫🇷 Lyon, France

centre Léon Bérard; 🇫🇷 Lyon, France

Institut du Cancer de Montpellier (ICM); 🇫🇷 Montpellier, France

Institut Curie; 🇫🇷 Saint-Cloud, France

Hôpital COCHIN AP-HP; 🇫🇷 Paris, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut de Cancérologie de l'Ouest (ICO); 🇫🇷 Saint-herblain, France

Hôpital Foch; 🇫🇷 Suresnes, France