Clinical trial NCT05646043: PREHAB - Improving Condition Before Surgery
Official title: PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Digestive System
Cancer, Rectum
Keywords: prehabilitation
cancer of the digestive system
cancer of the rectum
endurance walking
power training
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be enrolled in two parallel groups.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of enrolled patients
timeFrame: 3 months
measure: Number of patients completing the program
timeFrame: 3 months
measure: Individual patient compliance
timeFrame: 3 months
Secondary outcomes:
measure: Changes in spirometry examination results
timeFrame: 3 months
measure: Changes in the quality of life
timeFrame: 3 months
measure: Parameters monitored by the oncologist
timeFrame: 3 months
measure: Exercise program - number of steps/day
timeFrame: 3 months
measure: Exercise program - pressing force on the dynamometer
timeFrame: 3 months
measure: Exercise program - InBody examination
timeFrame: 3 months
measure: Exercise program - Body Mass Index
timeFrame: 3 months
measure: Exercise program - perceived exertion
timeFrame: 3 months
measure: Parameters monitored by the anesthesiologist - ASA value
timeFrame: 3 months
measure: Parameters monitored by the anesthesiologist - morbidity assessment
timeFrame: 3 months
measure: Parameters monitored by the anesthesiologist - preoperative analgesia
timeFrame: 3 months
measure: Parameters monitored by the anesthesiologist - postoperative opioid analgesia
timeFrame: 3 months
measure: Parameters monitored by the anesthesiologist - pain assessment
timeFrame: 3 months
measure: Laboratory examinations - complete blood count
timeFrame: 3 months
measure: Laboratory examinations - CRP values
timeFrame: 3 months
measure: Laboratory examinations - procalcitonin level
timeFrame: 3 months
measure: Laboratory examinations - nutritional parameters
timeFrame: 3 months
measure: Laboratory examinations - coagulation factors (aPTTp
timeFrame: 3 months
measure: Laboratory examinations - coagulation factors (fibrinogen)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Irina Chmelová, MD,PhD,MBA
role: PRINCIPAL_INVESTIGATOR
References: