PrehabilitationPREHABMETNCT04520737
Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
A study testing Physical Prehabilitation in people with Prehabilitation and Neoadjuvant Therapy, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Neoadjuvant Therapy, Liver Metastases
- What is being tested?
- Physical Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Written informed consent obtained from subject to participate in the study.
Who cannot join
- Age <18 years
- ASA health class status IV-V
- Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
- Medical contraindication to perform exercise
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
Laia Estalella, PhD, +34 628164461, laiaestalella2@gmail.com
About this study
Official title: Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented.
The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.
Read the detailed description
The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.
MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.
Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.
- Conditions
- Prehabilitation, Neoadjuvant Therapy, Liver Metastases
- Being tested
- Physical Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical PrehabilitationBehavioural
Also called Nutritional intervention, Psychological intervention, Smoking cessation, Comprehensive Geriatric Assessment (CGA) and co-morbidity assessment
The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
| Study group | Role | What they receive |
|---|---|---|
| 16W group | Active comparator | Multimodal prehabilitation program (MPP) will be implemented during 16 weeks, 12 weeks during chemotherapy (CT) and 4 weeks while waiting for surgery. Receives: Behavioral: Physical Prehabilitation |
| 4W group | Active comparator | Multimodal prehabilitation program (MPP) will start at the end of preoperative chemotherapy (CT) until surgery (4 weeks in total). Receives: Behavioral: Physical Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness- 6MWT
Change in physical fitness will be measured by the six-minute walk test (6MWT). This test measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Secondary outcomes (12)
Postoperative complications- Clavien-Dindo classification
The Clavien-Dindo classification consists of 7 grades. Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications; Grade III (IIIa, IIIb): Requiring surgical, endoscopic or radiological intervention; Grade IV (Iva, IVb): Life-threatening complication requiring IC/ICU management; Grade V: death of the patient.
Measured: Through study completion, up to one year postoperative
Postoperative complications- CCI
The Comprehensive Complication Index (CCI) integrates in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death).
Measured: Through study completion, up to one year postoperative
Postoperative hospital length of stay
The patient's postoperative length of stay will be recorded from the medical records. It will be calculated from the date of surgery until to the date of discharge from the hospital. It will be reported in days.
Measured: Postoperative period: assessed up to the first year postoperative
Readmissions rate
Rate of un-planned hospital readmissions within 30 days of discharge after hospitalization.
Measured: Postoperative period: Up to 30 postoperative days
Functional capacity- 30CST
The 30-second sit to stand test (30CST) measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Health-related quality of life- SF-36
Quality of life will be evaluated by using the SF-36 mental health score. This survey measures eight scales of health: physical function, role physical, role emotional, social functioning, bodily pain, general health, vitality, and mental health. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state.
Measured: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Psychological health- HADS
Emotional health will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS contains seven items, each scored from 0 to 3 points for anxiety and depression. It provides summary measures on a scale of 0-21, with scores exceeding 8 suggesting the presence of a mood disorder
Measured: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Functional capacity- Handgrip strength
It will be measured using an hydraulic hand dynamometer. Three measures from each hand will be taken, with patient seated and arm bent at a 90-degree angle. The average of the three measures for each hand will be recorded.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- PG-SGA
The Patient-Generated Subjective Global Assessment (PG-SGA) is a validated questionnaire used to assess the nutritional and functional status of cancer patients. The scoring system allows patients at risk for malnutrition to be identified and triaged for nutritional intervention. A score ≥9 indicates a critical need for nutritional intervention.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BMI
Body Mass Index (BMI) is weight in kilograms divided by height in meters squared.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BIA
The Bio-electrical Impedance Analysis (BIA) is a method to determine body composition. The measurement of body fat in relation to lean body mass.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- UMA
Upper-arm muscle area (UMA) is the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow.
Measured: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participant will be randomized (1:1) using seed, a Stata's random-number generated function. The subjects will be allocated into one of the two groups of the study.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laia Estalella Mercade, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Laia Estalella, PhD, Principal investigator, Hospital Universitari de Tarragona Joan XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520737
- Sponsor's protocol ID
- PREHABMET
- Acronym
- PREHABMET
- Status last verified
- Jun 2024
- First submitted
- 11 Aug 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04520737
- Acronym / sponsor ID
- PREHABMET / PREHABMET
- Conditions
- Prehabilitation, Neoadjuvant Therapy, Liver Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 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.
Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented.
The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.
Detailed description
The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.
MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.
Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant will be randomized (1:1) using seed, a Stata's random-number generated function. The subjects will be allocated into one of the two groups of the study.
| Arm | Type | Receives |
|---|---|---|
| 16W group | Active comparator | Behavioral: Physical PrehabilitationMultimodal prehabilitation program (MPP) will be implemented during 16 weeks, 12 weeks during chemotherapy (CT) and 4 weeks while waiting for surgery. |
| 4W group | Active comparator | Behavioral: Physical PrehabilitationMultimodal prehabilitation program (MPP) will start at the end of preoperative chemotherapy (CT) until surgery (4 weeks in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Written informed consent obtained from subject to participate in the study.
Key exclusion criteria (5 listed)
- Age <18 years
- ASA health class status IV-V
- Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
- Medical contraindication to perform exercise
- Inability to obtain informed 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 |
|---|---|---|
| Physical PrehabilitationAlso: Nutritional intervention, Psychological intervention, Smoking cessation, Comprehensive Geriatric Assessment (CGA) and co-morbidity assessmentThe prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment. | Behavioural | 16W group, 4W group |
Primary outcome
Physical Fitness- 6MWT
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Change in physical fitness will be measured by the six-minute walk test (6MWT). This test measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.
12 secondary outcomes
Postoperative complications- Clavien-Dindo classification
Time frame: Through study completion, up to one year postoperative
Postoperative complications- CCI
Time frame: Through study completion, up to one year postoperative
Postoperative hospital length of stay
Time frame: Postoperative period: assessed up to the first year postoperative
Readmissions rate
Time frame: Postoperative period: Up to 30 postoperative days
Functional capacity- 30CST
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Health-related quality of life- SF-36
Time frame: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Psychological health- HADS
Time frame: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Functional capacity- Handgrip strength
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- PG-SGA
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BMI
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BIA
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- UMA
Time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Laia Estalella, PhD principal investigator
Hospital Universitari de Tarragona Joan XXIII
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 Prehabilitation in people with Prehabilitation and Neoadjuvant Therapy, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 2 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laia Estalella, PhD (+34 628164461, laiaestalella2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Fitness- 6MWT (time frame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.