Cancer, Digestive SystemNCT05646043
PREHAB - Improving Condition Before Surgery
A study testing Physical training and Muscle strength training in people with Cancer, Digestive System and Cancer, Rectum, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Digestive System, Cancer, Rectum
- What is being tested?
- Physical training and Muscle strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- multivisceral resection
- planned non-surgical therapeutic procedure
- incomplete data
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Irina Chmelová, MD,PhD,MBA
About this study
Official title: 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).
Read the 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
- Being tested
- Physical training, Muscle strength training
- Keywords
- prehabilitation, cancer of the digestive system, cancer of the rectum, endurance walking, power training
- Medical subject headings
- Digestive System Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
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.
Muscle strength trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer of the digestive system | Active comparator | Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm. Receives: Behavioral: Physical training; Behavioral: Muscle strength training |
| Patients with cancer of the rectum | Active comparator | Patients with cancer of the rectum will be enrolled in this study arm. Receives: Behavioral: Physical training; Behavioral: Muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Number of patients completing the program
The number of patients who complete the prehabilitation program by the time of surgery.
Measured: 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
Measured: 3 months
Secondary outcomes (19)
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).
Measured: 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.
Measured: 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
Measured: 3 months
Exercise program - number of steps/day
The number of steps taken by the study subjects in a day will be counted.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Parameters monitored by the anesthesiologist - morbidity assessment
Morbidity assessment among the study population will be performed, using assessment of incidence and prevalence.
Measured: 3 months
Parameters monitored by the anesthesiologist - preoperative analgesia
The use of preoperative analgesia will be recorded and assessed.
Measured: 3 months
Parameters monitored by the anesthesiologist - postoperative opioid analgesia
The use of postoperative opioid analgesia will be recorded and assessed.
Measured: 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.
Measured: 3 months
Laboratory examinations - complete blood count
Complete blood count will be analyzed (g/L).
Measured: 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.
Measured: 3 months
Laboratory examinations - procalcitonin level
Procalcitonin levels will be analyzed (ng/L). This marker indicates the presence of infection.
Measured: 3 months
Laboratory examinations - nutritional parameters
Nutritional parameters - the levels of total protein, albumin and prealbumin will be analyzed (mg/dL).
Measured: 3 months
Laboratory examinations - coagulation factors (aPTTp
Coagulation factors - Activated Partial Thromboplastin Time (APTT) will be measured (in seconds).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Dec 2022
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, Digestive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be enrolled in two parallel groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina Chmelová, MD,PhD,MBA, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646043
- Sponsor's protocol ID
- 08/RVO-FNOs/2022
- Status last verified
- Jan 2024
- First submitted
- 15 Nov 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
Chmelova I, Pastucha D, Hudecek T, Guran Z, Ciecotkova S, Martinek L, Zubikova J, Matlova A, Dolezel J, Salounova D, Chmelo J. Prehabilitation during neoadjuvant therapy in patients with cancer of the upper gastrointestinal tract and rectum-the study protocol. Front Sports Act Living. 2025 Feb 3;6:1495398. doi: 10.3389/fspor.2024.1495398. eCollection 2024.
PubMed 39963182
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum
- ClinicalTrials.gov ID
- NCT05646043
- Acronym / sponsor ID
- 08/RVO-FNOs/2022
- Conditions
- Cancer, Digestive System, Cancer, Rectum
- Keywords
- prehabilitation, cancer of the digestive system, cancer of the rectum, endurance walking, power training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be enrolled in two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer of the digestive system | Active comparator | Behavioral: Physical training, Behavioral: Muscle strength trainingPatients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm. |
| Patients with cancer of the rectum | Active comparator | Behavioral: Physical training, Behavioral: Muscle strength trainingPatients with cancer of the rectum will be enrolled in this study arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingPhysical 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. | Behavioural | Patients with cancer of the digestive system, Patients with cancer of the rectum |
| Muscle strength trainingMuscle 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. | Behavioural | Patients with cancer of the digestive system, Patients with cancer of the rectum |
Primary outcome
Number of enrolled patients
Time frame: 3 months
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
Time frame: 3 months
The number of patients who complete the prehabilitation program by the time of surgery.
Individual patient compliance
Time frame: 3 months
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
19 secondary outcomes
Changes in spirometry examination results
Time frame: 3 months
Changes in the quality of life
Time frame: 3 months
Parameters monitored by the oncologist
Time frame: 3 months
Exercise program - number of steps/day
Time frame: 3 months
Exercise program - pressing force on the dynamometer
Time frame: 3 months
Exercise program - InBody examination
Time frame: 3 months
Exercise program - Body Mass Index
Time frame: 3 months
Exercise program - perceived exertion
Time frame: 3 months
Parameters monitored by the anesthesiologist - ASA value
Time frame: 3 months
Parameters monitored by the anesthesiologist - morbidity assessment
Time frame: 3 months
Parameters monitored by the anesthesiologist - preoperative analgesia
Time frame: 3 months
Parameters monitored by the anesthesiologist - postoperative opioid analgesia
Time frame: 3 months
Parameters monitored by the anesthesiologist - pain assessment
Time frame: 3 months
Laboratory examinations - complete blood count
Time frame: 3 months
Laboratory examinations - CRP values
Time frame: 3 months
Laboratory examinations - procalcitonin level
Time frame: 3 months
Laboratory examinations - nutritional parameters
Time frame: 3 months
Laboratory examinations - coagulation factors (aPTTp
Time frame: 3 months
Laboratory examinations - coagulation factors (fibrinogen)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39963182Chmelova I, Pastucha D, Hudecek T, Guran Z, Ciecotkova S, Martinek L, Zubikova J, Matlova A, Dolezel J, Salounova D, Chmelo J. Prehabilitation during neoadjuvant therapy in patients with cancer of the upper gastrointestinal tract and rectum-the study protocol. Front Sports Act Living. 2025 Feb 3;6:1495398. doi: 10.3389/fspor.2024.1495398. eCollection 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Chmelová, MD,PhD,MBA principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training and Muscle strength training in people with Cancer, Digestive System and Cancer, Rectum, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enrolled patients (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.