PREHAB - Improving Condition Before Surgery

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Cancer, Digestive System, Cancer, Rectum

Intervention / Treatment
-----------------
* Behavioral: Physical training
* Behavioral: Muscle strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects will be enrolled in two parallel groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with cancer of the digestive system<br>Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm. | Behavioral: Physical training<br>* 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.<br>Behavioral: Muscle strength training<br>* 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.<br>|
| Active Comparator: Patients with cancer of the rectum<br>Patients with cancer of the rectum will be enrolled in this study arm. | Behavioral: Physical training<br>* 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.<br>Behavioral: Muscle strength training<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enrolled patients | The number of patients who express an interest in being included in the study from all patients diagnosed and indicated for neoadjuvant therapy in the monitored period. the reasons for refusal to enroll in the study will be monitored. | 3 months | 
| Number of patients completing the program | The number of patients who complete the prehabilitation program by the time of surgery. | 3 months | 
| Individual patient compliance | Number of days when the patient wore the smart bracelet and performed or attempted to perform the exercise program out of the total number of days in the monitored period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in spirometry examination results | Changes in spirometry examination will be assessed, comparing the baseline values with the values after training (maximum tidal volume (ml/1kg of weight/1 min), anaerobic threshold (beats/min). | 3 months | 
| Changes in the quality of life | Changes in the quality of life will be monitored using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This questionnaire is designed to measure cancer patients' physical, psychological and social functions. | 3 months | 
| Parameters monitored by the oncologist | Number of patients with chemotherapy dose reduction or premature termination of chemotherapy, number of patients with complete chemotherapy, number of patients hospitalized due to chemotherapy toxicity | 3 months | 
| Exercise program - number of steps/day | The number of steps taken by the study subjects in a day will be counted. | 3 months | 
| Exercise program - pressing force on the dynamometer | The pressing force on the dynamometer (in kg) will be assessed at the beginning and at the end of the program. | 3 months | 
| Exercise program - InBody examination | The InBody examination (analysis of body composition in %) will be performed at the beginning and at the end of the program. | 3 months | 
| Exercise program - Body Mass Index | The value of Body Mass Index will be recorded at the beginning and at the end of the program will be assessed (in kg/m2), changes will be assessed. | 3 months | 
| Exercise program - perceived exertion | The perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale (RPE). RPE is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. The rating is from 6 to 20. | 3 months | 
| Parameters monitored by the anesthesiologist - ASA value | ASA value - the ASA physical status classification system is a system for assessing the fitness of patients before surgery. It is a five-category physical status classification defined by the American Society of Anesthesiologists. | 3 months | 
| Parameters monitored by the anesthesiologist - morbidity assessment | Morbidity assessment among the study population will be performed, using assessment of incidence and prevalence. | 3 months | 
| Parameters monitored by the anesthesiologist - preoperative analgesia | The use of preoperative analgesia will be recorded and assessed. | 3 months | 
| Parameters monitored by the anesthesiologist - postoperative opioid analgesia | The use of postoperative opioid analgesia will be recorded and assessed. | 3 months | 
| Parameters monitored by the anesthesiologist - pain assessment | The Numeric Pain Rating Scale will be used to assess pain. The Numeric Pain Rating Scale is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. | 3 months | 
| Laboratory examinations - complete blood count | Complete blood count will be analyzed (g/L). | 3 months | 
| Laboratory examinations - CRP values | C-Reactive Protein (CRP) will be assessed (in mg/L). C-reactive protein (CRP) is an acute phase protein that is produced in the liver. The levels increase rapidly in response to acute inflammation. | 3 months | 
| Laboratory examinations - procalcitonin level | Procalcitonin levels will be analyzed (ng/L). This marker indicates the presence of infection. | 3 months | 
| Laboratory examinations - nutritional parameters | Nutritional parameters - the levels of total protein, albumin and prealbumin will be analyzed (mg/dL). | 3 months | 
| Laboratory examinations - coagulation factors (aPTTp | Coagulation factors - Activated Partial Thromboplastin Time (APTT) will be measured (in seconds). | 3 months | 
| Laboratory examinations - coagulation factors (fibrinogen) | Coagulation factors - fibrinogen levels will be assessed (mg/dL). Higher and lower levels point to blood clotting disorders. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prehabilitation, cancer of the digestive system, cancer of the rectum, endurance walking, power training