Colorectal CancerPrehab_2NCT04595604
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
A study testing Trimodal rehabilitation + ERAS and ERAS + nutritional prehabilitation in people with Colorectal Cancer, run by St. Borbala Hospital at 2 sites in Hungary.
Trial summary
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks. ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Trimodal rehabilitation + ERAS and ERAS + nutritional prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesHungary
- Study dates
- 7 Sep 2020to 7 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with histologically proven primary colorectal adenocarcinoma
- any stage of colorectal cancer
- elective operation
- curative intention
- informed consent signed by patient
Who cannot join
- emergency operation
- palliative operation
- non-colorectal, second malignancy
- pregnancy
- patient not giving consent
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Department of Surgery, St. Borbala Hospital
Tatabánya, 2800
St. Borbala Hospital
Tatabánya, 2800
About this study
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.
ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.
Read more
Trimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.
This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.
Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.
Read the detailed description
Aim:
Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.
In the prospective, randomized (2:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.
Study protocol in details:
First visit: Outpatient Department of Surgery
On both arms:
- History taking (including family history and oncologic history);
- Physical examination
Operation indication, type of procedure and date of procedure agreed; Organizing further investigations, anesthesia; Operative risk assessment ("ACS - surgical risk calculator"); Study patient identifier Nr generated; Nurse-led ERAS/Prehab clinic: randomization
On both arms:
- Randomization (Prehabilitation Program / ERAS Program). 2:1
- Nurse led clinic assessment ("study nurse"):
.i. CaseReportForm (CRF) filled in.
.ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders).
.v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan).
.viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. . xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral. xiii. Fecal sample collected and stored at -86 C.
Physiotherapy, first visit
Both on control and interventional arms:
- Respiratory function test recorded.
- Physical status tested (6MWD) on a treadmill.
Just on Prehabilitation arm:
- Respiratory training education.
- Respiratory trainer device usage educated.
- Daily activity (walking) planned.
Physiotherapy - second/third/fourth visit (weekly)
Just on Prehabilitation arm:
Previous week activity reviewed as to workbook. Physical assessment: 6MWD, FVC. Next week activity planned. Psychic preparation
Just on Prehabilitation arm:
- Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.
Admission to the Surgical Ward a day before surgery
Both on control and interventional arm:
- Preoperative assessment:
.i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment. vi. Fecal sample collected and stored at -86 C.
- Preoperative preparation (as to ERAS protocol).
- Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
- Stoma education.
Dietary education. On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).
Postoperative follow up:
Both on control and interventional arms:
- Assessment (8th week post op.):
.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD). .v. Fecal sample collected and stored at -86 C.
- Long-term follow-up: 12, 24, 36, 48 and 60 months post operative assessment: Behavioral changes (alcohol abstinence, smoking cessation) Daily physical activity routine assessment. SF36 quality of life assessment Oncological outcome: local recurrence rate, distant recurrence rate, disease free survival, overall survival.
- Conditions
- Colorectal Cancer
- Being tested
- Trimodal rehabilitation + ERAS, ERAS + nutritional prehabilitation
- Keywords
- ERAS, prehabilitation, fecal microbata
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimodal rehabilitation + ERASProcedure or surgery
Also called Prehabilitation
Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.
ERAS + nutritional prehabilitationProcedure or surgery
Also called Enhanced Recovery After Surgery
Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Trimodal prehabilitation + ERAS | Experimental | Patients receiving a formal preoperative preparation on:
Physical status (walking, respiratory training) Nutrition (nutritional supplements) Mental status (weekly groups led by clinical psychologist on anxiety and depression management).
Each patient will be treated in an ERAS program preoperatively. Receives: Procedure: Trimodal rehabilitation + ERAS |
| ERAS + nutritional prehabilitation | Active comparator | Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements. Receives: Procedure: ERAS + nutritional prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Postoperative length of hospital stay in days.
Measured: 45 days
Number of days spent on ICU (Intensive care unit).
Number of days observed on ICU right after operation.
Measured: 45 days
Morbidity (early) classified after Clavien-Dindo.
7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Measured: 7 days (until 8th postoperative day) postoperative
Morbidity (long term) classified after Clavien-Dindo.
30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Measured: 30 days (until 31st postoperative day)
30-day mortality
30-day mortality of each patient will be recorded.
Measured: 30 days (until 31st postoperative day)
90-day mortality
90-day mortality of each patient will be recorded.
Measured: 90 days (until 91st postoperative day)
Change in preoperative functional status - 6MWD by operation
6MWD (6-minute walking distance test)
Measured: Measured points: 4 weeks before surgery, on day of hospital admission
Change in postoperative functional status - 6MWD by the end of rehabilitation
6MWD (6-minute walking distance test)
Measured: Measured points: 4 weeks before surgery, 8 weeks after operation
Change in preoperative functional status - FVC by operation
Measured points: 4 weeks before surgery, on day of hospital admission
Measured: Measured points: 4 weeks before surgery, on day of hospital admission
Change in preoperative functional status - FVC by the end of rehabilitation
Measured points: 4 weeks before surgery, 8 weeks after operation
Measured: Measured points: 4 weeks before surgery, 8 weeks after operation
Secondary outcomes (1)
Change of alpha- and beta-diversity of fecal microbata
Fecal microbara diversity will be measured at diagnosis, at the time of operation and 8 weeks after operation. We will assess diversity changes related to the intervention.
Measured: Measured points: 4 weeks before surgery, on day of hospital admission and 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start7 Sep 2020
- Primary completion7 Aug 2022
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation. 2:1 randomization will be performed for interventional and control arm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Borbala Hospital
- Sponsor type
- Other government
- Collaborators
- Biological Research Centre, Szeged
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595604
- Sponsor's protocol ID
- ERASvsPrehab_2
- Acronym
- Prehab_2
- Status last verified
- Feb 2024
- First submitted
- 30 Sep 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
PubMed 37162250Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
PubMed 35588252
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
- ClinicalTrials.gov ID
- NCT04595604
- Acronym / sponsor ID
- Prehab_2 / ERASvsPrehab_2
- Conditions
- Colorectal Cancer
- Keywords
- ERAS, prehabilitation, fecal microbata
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- St. Borbala HospitalOther government
- Collaborators
- Biological Research Centre, Szeged
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 20 Oct 2020 (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.
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.
ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.
Trimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.
This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.
Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.
Detailed description
Aim:
Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.
In the prospective, randomized (2:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.
Study protocol in details:
First visit: Outpatient Department of Surgery
On both arms:
- History taking (including family history and oncologic history);
- Physical examination
Operation indication, type of procedure and date of procedure agreed; Organizing further investigations, anesthesia; Operative risk assessment ("ACS - surgical risk calculator"); Study patient identifier Nr generated; Nurse-led ERAS/Prehab clinic: randomization
On both arms:
- Randomization (Prehabilitation Program / ERAS Program). 2:1
- Nurse led clinic assessment ("study nurse"):
.i. CaseReportForm (CRF) filled in.
.ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders).
.v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan).
.viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. . xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral. xiii. Fecal sample collected and stored at -86 C.
Physiotherapy, first visit
Both on control and interventional arms:
- Respiratory function test recorded.
- Physical status tested (6MWD) on a treadmill.
Just on Prehabilitation arm:
- Respiratory training education.
- Respiratory trainer device usage educated.
- Daily activity (walking) planned.
Physiotherapy - second/third/fourth visit (weekly)
Just on Prehabilitation arm:
Previous week activity reviewed as to workbook. Physical assessment: 6MWD, FVC. Next week activity planned. Psychic preparation
Just on Prehabilitation arm:
- Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.
Admission to the Surgical Ward a day before surgery
Both on control and interventional arm:
- Preoperative assessment:
.i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment. vi. Fecal sample collected and stored at -86 C.
- Preoperative preparation (as to ERAS protocol).
- Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
- Stoma education.
Dietary education. On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).
Postoperative follow up:
Both on control and interventional arms:
- Assessment (8th week post op.):
.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD). .v. Fecal sample collected and stored at -86 C.
- Long-term follow-up: 12, 24, 36, 48 and 60 months post operative assessment: Behavioral changes (alcohol abstinence, smoking cessation) Daily physical activity routine assessment. SF36 quality of life assessment Oncological outcome: local recurrence rate, distant recurrence rate, disease free survival, overall survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation. 2:1 randomization will be performed for interventional and control arm
| Arm | Type | Receives |
|---|---|---|
| Trimodal prehabilitation + ERAS | Experimental | Procedure: Trimodal rehabilitation + ERASPatients receiving a formal preoperative preparation on: Physical status (walking, respiratory training) Nutrition (nutritional supplements) Mental status (weekly groups led by clinical psychologist on anxiety and depression management). Each patient will be treated in an ERAS program preoperatively. |
| ERAS + nutritional prehabilitation | Active comparator | Procedure: ERAS + nutritional prehabilitationEach patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with histologically proven primary colorectal adenocarcinoma
- any stage of colorectal cancer
- elective operation
- curative intention
- informed consent signed by patient
Key exclusion criteria (5 listed)
- emergency operation
- palliative operation
- non-colorectal, second malignancy
- pregnancy
- patient not giving consent
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 |
|---|---|---|
| Trimodal rehabilitation + ERASAlso: PrehabilitationPrehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy. | Procedure or surgery | Trimodal prehabilitation + ERAS |
| ERAS + nutritional prehabilitationAlso: Enhanced Recovery After SurgeryEnhanced Recovery Program, including preoperative 4 weeks nutritional supplementation. | Procedure or surgery | ERAS + nutritional prehabilitation |
Primary outcome
Length of hospital stay
Time frame: 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit).
Time frame: 45 days
Number of days observed on ICU right after operation.
Morbidity (early) classified after Clavien-Dindo.
Time frame: 7 days (until 8th postoperative day) postoperative
7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Morbidity (long term) classified after Clavien-Dindo.
Time frame: 30 days (until 31st postoperative day)
30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
30-day mortality
Time frame: 30 days (until 31st postoperative day)
30-day mortality of each patient will be recorded.
90-day mortality
Time frame: 90 days (until 91st postoperative day)
90-day mortality of each patient will be recorded.
Change in preoperative functional status - 6MWD by operation
Time frame: Measured points: 4 weeks before surgery, on day of hospital admission
6MWD (6-minute walking distance test)
Change in postoperative functional status - 6MWD by the end of rehabilitation
Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
6MWD (6-minute walking distance test)
Change in preoperative functional status - FVC by operation
Time frame: Measured points: 4 weeks before surgery, on day of hospital admission
Measured points: 4 weeks before surgery, on day of hospital admission
Change in preoperative functional status - FVC by the end of rehabilitation
Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
Measured points: 4 weeks before surgery, 8 weeks after operation
1 secondary outcome
Change of alpha- and beta-diversity of fecal microbata
Time frame: Measured points: 4 weeks before surgery, on day of hospital admission and 8 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 37162250Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
- Derived from this study: PubMed 35588252Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimodal rehabilitation + ERAS and ERAS + nutritional prehabilitation in people with Colorectal Cancer, run by St. Borbala Hospital at 2 sites in Hungary.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 45 days). The study lists 10 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 NCT04595604, which also lists 2 linked publications.
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 29 Nov 2024.