CANCER
Conditions
Keywords
gastrointestinal cancer
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.
Interventions
OTHERAPA and nutrition intervention
\- APA intervention: weekly supervised sessions at home with the APA professional combined with unsupervised sessions, alone or with the APA partner, for 8 weeks. The supervised session will be broken down as follows: warm-up block (approximately 10'), aerobic block (15'), muscle strengthening/resistance block (15') and stretching/relaxation block (10'). The remaining 10' will be used to review the session and the individual sessions. This program can be adapted to the needs and abilities of the patient if necessary. \- Nutritional intervention: dietitian weekly visits at home during 8 weeks with dietetic counseling; decision of oral, enteral and/or parenteral feeding validated by the clinical steering committee according to the Société Francophone de Nutrition Clinique et Métabolisme (SFNCM) guidelines.
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Intervention : standard of care plus a supervised 8-week combined APA and nutrition individualized program
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
CONTACTAnne-Sophie PLISSONNIER
CONTACTCindy NEUZILLET, MD
PRINCIPAL_INVESTIGATORCindy NEUZILLET, MD
Hôpital Paul Brousse
Outcome results
None listed