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

ConditionCANCER
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Neuroendocrine carcinoma histology.

Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice.

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • APA and nutrition intervention

    Other 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: APA and nutrition programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess the feasibility of a supervised 8-week combined APA and nutrition individualized program

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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