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PREHAB - Improving Condition Before Surgery

Primary Purpose

Cancer, Digestive System, Cancer, Rectum

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Physical training
Muscle strength training
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Digestive System focused on measuring prehabilitation, cancer of the digestive system, cancer of the rectum, endurance walking, power training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with cancer of the digestive system

Patients with cancer of the rectum

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Number of patients completing the program
The number of patients who complete the prehabilitation program by the time of surgery.
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

Secondary Outcome Measures

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).
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.
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
Exercise program - number of steps/day
The number of steps taken by the study subjects in a day will be counted.
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.
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.
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.
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.
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.
Parameters monitored by the anesthesiologist - morbidity assessment
Morbidity assessment among the study population will be performed, using assessment of incidence and prevalence.
Parameters monitored by the anesthesiologist - preoperative analgesia
The use of preoperative analgesia will be recorded and assessed.
Parameters monitored by the anesthesiologist - postoperative opioid analgesia
The use of postoperative opioid analgesia will be recorded and assessed.
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.
Laboratory examinations - complete blood count
Complete blood count will be analyzed (g/L).
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.
Laboratory examinations - procalcitonin level
Procalcitonin levels will be analyzed (ng/L). This marker indicates the presence of infection.
Laboratory examinations - nutritional parameters
Nutritional parameters - the levels of total protein, albumin and prealbumin will be analyzed (mg/dL).
Laboratory examinations - coagulation factors (aPTTp
Coagulation factors - Activated Partial Thromboplastin Time (APTT) will be measured (in seconds).
Laboratory examinations - coagulation factors (fibrinogen)
Coagulation factors - fibrinogen levels will be assessed (mg/dL). Higher and lower levels point to blood clotting disorders.

Full Information

First Posted
November 15, 2022
Last Updated
December 12, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05646043
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Digestive System, Cancer, Rectum
Keywords
prehabilitation, cancer of the digestive system, cancer of the rectum, endurance walking, power training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be enrolled in two parallel groups.
Masking
None (Open Label)
Masking Description
No masking is used in this study.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with cancer of the digestive system
Arm Type
Active Comparator
Arm Description
Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm.
Arm Title
Patients with cancer of the rectum
Arm Type
Active Comparator
Arm Description
Patients with cancer of the rectum will be enrolled in this study arm.
Intervention Type
Behavioral
Intervention Name(s)
Physical training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Muscle strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of enrolled patients
Description
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.
Time Frame
3 months
Title
Number of patients completing the program
Description
The number of patients who complete the prehabilitation program by the time of surgery.
Time Frame
3 months
Title
Individual patient compliance
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in spirometry examination results
Description
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).
Time Frame
3 months
Title
Changes in the quality of life
Description
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.
Time Frame
3 months
Title
Parameters monitored by the oncologist
Description
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
Time Frame
3 months
Title
Exercise program - number of steps/day
Description
The number of steps taken by the study subjects in a day will be counted.
Time Frame
3 months
Title
Exercise program - pressing force on the dynamometer
Description
The pressing force on the dynamometer (in kg) will be assessed at the beginning and at the end of the program.
Time Frame
3 months
Title
Exercise program - InBody examination
Description
The InBody examination (analysis of body composition in %) will be performed at the beginning and at the end of the program.
Time Frame
3 months
Title
Exercise program - Body Mass Index
Description
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.
Time Frame
3 months
Title
Exercise program - perceived exertion
Description
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.
Time Frame
3 months
Title
Parameters monitored by the anesthesiologist - ASA value
Description
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.
Time Frame
3 months
Title
Parameters monitored by the anesthesiologist - morbidity assessment
Description
Morbidity assessment among the study population will be performed, using assessment of incidence and prevalence.
Time Frame
3 months
Title
Parameters monitored by the anesthesiologist - preoperative analgesia
Description
The use of preoperative analgesia will be recorded and assessed.
Time Frame
3 months
Title
Parameters monitored by the anesthesiologist - postoperative opioid analgesia
Description
The use of postoperative opioid analgesia will be recorded and assessed.
Time Frame
3 months
Title
Parameters monitored by the anesthesiologist - pain assessment
Description
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.
Time Frame
3 months
Title
Laboratory examinations - complete blood count
Description
Complete blood count will be analyzed (g/L).
Time Frame
3 months
Title
Laboratory examinations - CRP values
Description
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.
Time Frame
3 months
Title
Laboratory examinations - procalcitonin level
Description
Procalcitonin levels will be analyzed (ng/L). This marker indicates the presence of infection.
Time Frame
3 months
Title
Laboratory examinations - nutritional parameters
Description
Nutritional parameters - the levels of total protein, albumin and prealbumin will be analyzed (mg/dL).
Time Frame
3 months
Title
Laboratory examinations - coagulation factors (aPTTp
Description
Coagulation factors - Activated Partial Thromboplastin Time (APTT) will be measured (in seconds).
Time Frame
3 months
Title
Laboratory examinations - coagulation factors (fibrinogen)
Description
Coagulation factors - fibrinogen levels will be assessed (mg/dL). Higher and lower levels point to blood clotting disorders.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Chmelová, MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Irina Chmelová, MD,PhD,MBA
First Name & Middle Initial & Last Name & Degree
Lubomír Martínek, Assoc.Prof.,MD,PhD
First Name & Middle Initial & Last Name & Degree
Jana Zubíková, MD,MBA
First Name & Middle Initial & Last Name & Degree
Alena Mátlová, MD
First Name & Middle Initial & Last Name & Degree
Dalibor Pastucha, Assoc.Prof.,MD
First Name & Middle Initial & Last Name & Degree
Tomáš Hudeček, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Learn more about this trial

PREHAB - Improving Condition Before Surgery

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