ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: APA and nutrition intervention.
- Who it may be relevant to
- Registry conditions: CANCER. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other APA 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 th
Primary outcome measures
- Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Signed and dated informed consent.
- Age ≥ 18 years (no superior limit), men and women.
- First-line treatment (chemotherapy and/or immunotherapy) for advanced disease (previous adjuvant therapy allowed).
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of digestive tract (colorectal, esogastric, pancreas, biliary tract).
- Locally advanced or metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed).
- ECOG PS 0-2. Note: patient with ECOG PS 3-4 are excluded because they are usually not eligible for chemotherapy.
- 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).
- Life expectancy ≥ 8 weeks.
- Able to answer questionnaires in French.
- Availability of an APA partner (family member or friend who will attend the exercise sessions at least once a week).
- Registration in a national health care system (Couverture Maladie Universelle, CMU included).
Exclusion criteria
- Neuroendocrine carcinoma histology.
- 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.
- 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).
- 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.
- 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.
- Pregnancy or breastfeeding.
- Protected adults (individuals under guardianship by court order).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 18 centers
- CHRU de Tours — Tours
- Institut du cancer Avignon-Provence — Avignon
- Institut Bergonié — Bordeaux
- Centre de Lutte Contre le Cancer Jean Perrin — Clermont-Ferrand
- Institut Daniel Hollard - Groupe Hospitalier Mutualiste — Grenoble
- centre Oscar Lambret — Lille
- Hôpital de la Croix Rousse - Hospices Civils de Lyon — Lyon
- centre Léon Bérard — Lyon
- … and 10 more centers
Identifiers
NCT: NCT05441163 · IC 2021-01