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Official title ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers
ClinicalTrials.gov ID: NCT05441163
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Neuroendocrine carcinoma histology.
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice. Note: bone or brain metastases...
- Nonfunctional gastrointestinal tract compromising oral/enteral feeding. Note: gastrointestinal tract obstruction is allowed if the tumor can be...
- Participation to another physical activity or nutritional structured intervention program (in the first two months). Note: participation to another...
- 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...
- Pregnancy or breastfeeding.
See the full eligibility 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...
- 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).
- 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...
- 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...
- 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...
- 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...
- Pregnancy or breastfeeding.
- Protected adults (individuals under guardianship by court order).
The study team makes the final eligibility decision.
Where it's taking place
- Tours, Institut Curie, France
- Avignon, France
- Bordeaux, France
- Clermont-Ferrand, France
- Grenoble, France
- Lille, France
- Lyon, France
- Montpellier, France
- Paris, France
- Reims, France
- Rennes, France
- Saint-Cloud, France
- Saint-Herblain, France
- Suresnes, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tours, Institut Curie, France; Avignon, France; Bordeaux, France; Clermont-Ferrand, France; Grenoble, France; Lille, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.