PREHAB - Improving Condition Before Surgery

University Hospital Ostrava

Status: Enrolling

Conditions: Cancer, Digestive System; Cancer, Rectum

Treatments: Behavioral: Muscle strength training; Behavioral: Physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT05646043

08/RVO-FNOs/2022

Details and patient eligibility

About

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

Full description

With the aim of achieving downstaging, downsizing, and reducing the risk of recurrence, neoadjuvant chemotherapy, possibly chemoradiotherapy - i.e. neoadjuvant therapy is indicated in the preoperative period for patients with cancer of the upper digestive tract and rectal cancer.

Chemotherapy has a negative impact not only on the overall physical and mental condition of the patient but also on the quality of life and on the daily activities of the individual, especially in the period when the organism is facing an abnormal stress load in the sense of extensive surgical procedures.

Recently, attention and efforts to improve postoperative morbidity and mortality have increasingly focused on the preoperative period. The concept of prehabilitation, which is defined as an intervention improving functional capacity before an upcoming physiological stressor, appears as a way to contribute to this. This fact is evidenced by a number of published references.

The main aim of the study is to confirm or refute the feasibility of the prehabilitation program during neoadjuvant therapy in two diagnostic groups of patients:

• • Patients with cancer of the upper digestive tract
• • Patients with rectal cancer

The prehabilitation program will be implemented in the patient's home environment.

The study aims to answer the basic research question of whether selected patients will be able to complete a home exercise regimen during the preoperative period when they will undergo neoadjuvant therapy.

As part of the study, the program's security and feasibility will be tested.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• radically operable locally advanced cancer of the esophagus, esophagogastric junction, stomach
• radically operable locally advanced carcinoma of the rectum
• the patient is able to handle the planned surgical resection procedure
• planned preoperative neoadjuvant therapy
• age > 18 years
• the ability to complete a spiroergometric examination
• the ability to carry out a prehabilitation program consent to participate in the study confirmed by signing the informed consent

Exclusion criteria

• contraindications for spiroergometric examination
• limitation on the part of the locomotor system to spiroergometric examination or daily exercise (e.g. amputation, severe gonarthrosis, coxarthrosis)
• inoperability determined by the interdisciplinary team
• inability to manage the planned operational performance
• acute surgical performance
• synchronous malignant disease
• multivisceral resection
• planned non-surgical therapeutic procedure
• incomplete data

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patients with cancer of the digestive system

Active Comparator group

Description:

Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm.

Treatment:

Behavioral: Muscle strength training

Behavioral: Physical training

Patients with cancer of the rectum

Active Comparator group

Description:

Patients with cancer of the rectum will be enrolled in this study arm.

Treatment:

Behavioral: Muscle strength training

Behavioral: Physical training