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

Study Overview
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Brief Summary
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The ProActIF-01 trial aims to assess the efficacy of a supervised 8-week combined APA and nutrition individualized program on survival without HRQoL deterioration (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC QLQ-C30, 1 targeted dimension), in advanced lung or digestive cancer patients.

Official Title
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ProActIF-01 Trial: Randomized Study of Evaluation of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Lung or Digestive Cancers

Conditions
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CANCER

Intervention / Treatment
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* Other: APA and nutrition intervention


Participation Criteria
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Eligibility Criteria
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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 lung or 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/small cell lung 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. One or more major criteria for risk of refeeding syndrome: weight loss >15% in 3-6 months or BMI <16 kg/m2 or no nutritional intake for > 10 days 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). Pregnancy or breastfeeding. Protected adults (individuals under guardianship by court order).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: expermiental arm : supervised 8-week combined APA and nutrition individualized program control arm : standard of care specific to each site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APA and nutrition program<br> | Other: APA and nutrition intervention<br>* - 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.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL deterioration free survival (QFS) | HRQoL deterioration free survival (QFS) will be assessed by the EORTC QLQ-C30 [40] with 1 targeted dimension: Global Health/Quality of Life dimension. QFS will be defined as the time interval form inclusion in the study to the observation of the first clinically significant deterioration of the Global Health/QoL score compared to the baseline (i.e. decrease of at least 10 points), maintaining this deterioration over time (i.e. all scores following the deterioration will remain 10 points under the baseline score), or death. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal cancer, lung cancer