ProActIF-01 Trial: Feasibility Study of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Digestive Cancers (ProActIF-01)
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne-Sophie PLISSONNIER
- Phone Number: 0033147112378
- Email: anne-sophie.plissonnier@curie.fr
Study Contact Backup
- Name: Cindy NEUZILLET, MD
- Email: cindy.neuzillet@aphp.fr
Study Locations
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-
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Avignon, France, 84000
- Recruiting
- Institut du cancer Avignon-Provence
-
Contact:
- May MABRO, MD
-
Principal Investigator:
- May MABRO, MD
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Bordeaux, France, 33076
- Withdrawn
- Institut Bergonie
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Clermont-Ferrand, France, 63011
- Recruiting
- Centre de Lutte Contre le Cancer Jean Perrin
-
Contact:
- Florence OSAER-POLYCARPE, MD
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Principal Investigator:
- Florence OSAER-POLYCARPE
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Grenoble, France, 38000
- Withdrawn
- Institut Daniel Hollard - Groupe Hospitalier Mutualiste
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Lille, France, 59020
- Withdrawn
- Centre Oscar Lambret
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Lyon, France, 69373
- Recruiting
- Centre Leon Berard
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Contact:
- Pamela FUNK DEBLEDS, MD
-
Principal Investigator:
- Pamela FUNK DEBLEDS
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Lyon, France, 69004
- Recruiting
- Hôpital de la croix Rousse - Hospices Civils de Lyon
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Contact:
- Mélissa GRUNER, MD
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Principal Investigator:
- Mélissa Gruner, MD
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Montpellier, France, 34298
- Withdrawn
- Institut du Cancer de Montpellier (ICM)
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Paris, France, 75005
- Recruiting
- Institut Curie
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Contact:
- Timothée MARCHAL, MD
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Principal Investigator:
- Timothée MARCHAL, MD
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Paris, France, 75014
- Withdrawn
- Hôpital Cochin AP-HP
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Reims, France, 51092
- Recruiting
- CHU Reims
-
Principal Investigator:
- Olivier BOUCHE, MD
-
Contact:
- Olivier BOUCHE, MD
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Reims, France, 51100
- Withdrawn
- Institut Jean Godinot
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Rennes, France
- Withdrawn
- Centre Eugene Marquis
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Saint-Cloud, France, 92210
- Recruiting
- Institut Curie
-
Contact:
- Lucie GENTILHOMME, MD
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Principal Investigator:
- Lucie GENTILHOMME, MD
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Saint-Herblain, France, 44805
- Withdrawn
- Institut de Cancérologie de l'Ouest (ICO)
-
Suresnes, France, 92150
- Withdrawn
- Hôpital Foch
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Villejuif, France, 94800
- Not yet recruiting
- Hôpital Paul Brousse
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Contact:
- Cindy NEUZILLET
-
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Institut Curie
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Tours, Institut Curie, France, 37044
- Recruiting
- CHRU de Tours
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Principal Investigator:
- Thierry LECOMTE, MD
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Contact:
- Thierry LECOMTE, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: APA and nutrition program
|
- 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program
Time Frame: 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:
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cindy NEUZILLET, MD, Hôpital Paul Brousse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Neoplasms
- Gastrointestinal Neoplasms
- Therapeutics
- Hydrolases
- Enzymes
- Enzymes and Coenzymes
- Nutrition Therapy
- Peptide Hydrolases
- Metalloproteases
- Exopeptidases
- Metalloexopeptidases
- Aminopeptidases
- Diet Therapy
- Glutamyl Aminopeptidase
Other Study ID Numbers
- IC 2021-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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