NCT05646043

PREHAB - Improving Condition Before Surgery

PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cancer, Digestive System
• Cancer, Rectum

Interventions

Type	Name	Description
BEHAVIORAL	Physical training	Physical training consists of endurance walking and strength training. The basis for determining the number of steps per day is the baseline value of each patient. This will increase by 10-15% every week until the surgery date. The assumption of a total load increase is 120-180% compared to the baseline.
BEHAVIORAL	Muscle strength training	Muscle strength training will take place using exercises to strengthen the upper and lower limbs and to strengthen the trunk. There will be a set of 5 exercises in two difficulty variants. The study subjects will perform this set 7 days a week, and will repeat the assembly a total of two times. The total time of strength training is 10 min.

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2022-12-12
• Last updated: 2024-01-18

Locations

1 site across 1 country: Czechia