PREHAB - Improving Condition Before Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer, Rectum; Cancer, Digestive System
• Intervention / Treatment: Behavioral: Physical training; Behavioral: Muscle strength training

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Irina Chmelová, MD,PhD,MBA
      • Sub-Investigator: Lubomír Martínek, Assoc.Prof.,MD,PhD
      • Sub-Investigator: Jana Zubíková, MD,MBA
      • Sub-Investigator: Alena Mátlová, MD
      • Sub-Investigator: Dalibor Pastucha, Assoc.Prof.,MD
      • Sub-Investigator: Tomáš Hudeček, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with cancer of the digestive system; Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm.	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.
Active Comparator: Patients with cancer of the rectum; Patients with cancer of the rectum will be enrolled in this study arm.	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.

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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Irina Chmelová, MD,PhD,MBA, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: prehabilitation; cancer of the digestive system; cancer of the rectum; endurance walking; power training
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 08/RVO-FNOs/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No