Cancer SurgeryPROPOSE-RCTNCT06788834
Multimodal Prehabilitation in Cancer Surgery
A study testing Multimodal prehabilitation Program in people with Cancer Surgery, run by Università Vita-Salute San Raffaele at 9 sites in Italy.
Trial summary
The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Surgery
- What is being tested?
- Multimodal prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 9 sitesItaly
- Study dates
- 30 Jan 2025to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient (age > 18 years);
- Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
- Signed informed consent.
Who cannot join
- Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
- Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
- Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
- American Society of Anesthesiologists (ASA) physical status classes 4-5;
- Disabling orthopedic and neuromuscular disease;
- Psychosis, dementia;
- Symptomatic anemia with a hemoglobin value < 7 gr/dl.
- Patients with both optimal functional capacity (a Duke activity status index [DASI] score > 45) and optimal nutritional status (NRS-nutrition screening tool-score < 2).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
Policlinico Universitario AOU Renato Dulbecco di Catanzaro
Catanzaro, Italy, 88100
Eugenio Garofalo, Professor, +393498125841, eugenio.garofalo@gmail.com
- Not yet recruiting
AOU Careggi
Florence, Italy, 50134
Gabriele Baldini, Professor, +393333196036, gabriele.baldini@unifi.it
- Not yet recruiting
Ospedale Galliera di Genova
Genova, Italy, 16128
Claudia Brusasco, Doctor, +393291185009, claudia.brusasco@gmail.com
- Not yet recruiting
ASSTN GOM Niguarda
Milan, Italy, 20162
Monica Gualtierotti, Doctor, +390264447918, monica.gualtierotti@ospedaleniguarda.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milan, 20132
Marina Pieri, MD, 0226438173 ext. +39, pieri.marina@hsr.it
Marina Pieri, MD
- Not yet recruiting
IRCCS Ospedale San Gerardo dei Tintori
Monza, Italy, 20900
Luca C Nespoli, Professor, +393201797391, luca.nespoli@unimib.it
- Recruiting
Ospedale Vanvitelli di Napoli
Naples, Italy, 80129
Pasquale Sansone, Professor, +393384969395, pasquale.sansone@unicampania.it
- Not yet recruiting
AOPD Padova
Padova, Italy, 35128
Nicola Passuello, Doctor, +393482245159, nicola.passuello@aopd.veneto.it
- Not yet recruiting
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine, Italy, 33100
Tiziana Bove, Professor, +393474785763, tiziana.bove@asufc.sanita.fvg.it
About this study
Official title: Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial
The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.
The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.
Read the detailed description
The standard treatment for most solid cancer includes surgery and concurrent medical therapies, both of which have been shown to significantly improve prognosis. However, cancer treatments impose impactful physiological stress and have detrimental effects on acute and long-term health outcomes.
Physical, nutritional, and mental status can influence surgical outcomes, functional recovery and quality of life throughout the course of the disease.
The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period provides a unique opportunity to address comorbidities and modifiable risk factors. In addition, the metabolic stress induced by neoadjuvant therapy has been documented to frequently result in muscle atrophy and diminished functional capacity. The recognition that selected risk factors of poor postoperative outcome can be modified has prompted clinicians to identify proactive interventions to facilitate the recovery process. In this context, prehabilitation, aimed at enhancing the patients' functional capacity to enable them to withstand the physiological stress of surgery, has emerged as a promising approach. Although the term prehabilitation is not novel, the concept of optimizing patients before acute stressor or treatment has gained attention over the last decade. Nonetheless, quantifiable evidence of its effectiveness has yet to be fully demonstrated.
This study is a multicenter randomized controlled trial to assess the efficacy of personalized procedure-specific prehabilitation programs on patient-centered surgical outcomes. A total of 400 patients will be recruited by systematic screening of patients scheduled for elective surgical procedures. All patients undergoing elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery undergoing major cancer surgery will be screened for eligibility and those who meet the inclusion/exclusion criteria will be approached for consent. Research personnel will use a web-based randomization system to assign patients (1:1 ratio) to either the prehabilitation or control arm. Study personnel will also collect data on recruitment rates, with reasons for non-enrolment.
Eligible patients will be randomly assigned to 1 of 2 treatments:
- multimodal prehabilitation program for at least three weeks started as soon as possible before surgery;
- standard care.
The multimodal prehabilitation program will be individualized by carefully integrating and adapting various components to meet individual needs. The program will last at least three weeks (plus maintenance in case of delayed surgery), and will incorporate exercise training, nutritional therapy, and anxiety reduction techniques. After enrollment, patients will receive initial contact from trained personnel through telemedicine. To ensure personalized care, a comprehensive assessment will be conducted to identify specific physical, nutritional, or psychological challenges. Based on this assessment, a customized intervention plan will be prescribed to achieve tailored exercise training, optimized nutrition, and effective distress-coping strategies. All patients will be reassessed the day before surgery and 30 days after surgery. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, nutrition optimization, or distress-coping techniques-or a combination of these
- Conditions
- Cancer Surgery
- Being tested
- Multimodal prehabilitation Program
- Keywords
- Prehabilitation, Functional recovery, Relaxation, Exercise, Diet, Nutrition, Functional walking, Hospital stay, Multimodal prehabilitation program, Standard treatment, Anesthesiology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitation ProgramBehavioural
A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase.
Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effects. The duration of the program will be set at a minimum of three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | The prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery). Receives: Behavioral: Multimodal prehabilitation Program |
| Control group | No intervention | Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification
Measured: 30 days after surgery
Secondary outcomes (6)
Time to Functional Recovery (TFR)
Faster return to basal functional preoperative capacity in treatment group
Measured: 30 days after surgery
Lenght of hospital stay (LOS)
Reduction of lenght of hospital stay in treatment group
Measured: 30 days after surgery
Days at home up to 30 days after surgery (DAH-30)
The mean number of days at home in the first 30 days after surgery will be compared between groups
Measured: 30 days after surgery
Complication severity
Assess complication severity as measured by the Comprehensive Complication Index (CCI)
Measured: 30 days after surgery
Proportion of patients returning to preoperative functional walking capacity
Improvement in the return to basal functional preoperative capacity
Measured: 30 days after surgery
Self-reported activity status and generic health related quality of life
Assess quality of life in the first 30 days at home after surgery using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire, a validated tool for evaluating health-related quality of life. The outcome will be reported as the mean EQ-5D-5L index score and the mean EQ-VAS score measured at 30 days postoperatively.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start30 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cancer SurgeryStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Pasquale Sansone, Prof. Eugenio Garofalo, Prof. Tiziana Bove, Dr. Claudia Brusasco, Prof. Gabriele Baldini, Dr. Nicola Passuello, Dr. Monica Gualtierotti, Prof. Luca Carlo Nespoli
- Responsible party
- Principal investigator, Marina Pieri, Università Vita-Salute San Raffaele
- Investigators
- Marina Pieri, Medical Doctor, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788834
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12378183
- Acronym
- PROPOSE-RCT
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.
PubMed 29262307Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
PubMed 29452805Molenaar 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 35588252Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
PubMed 23756434Lemanne D, Cassileth B, Gubili J. The role of physical activity in cancer prevention, treatment, recovery, and survivorship. Oncology (Williston Park). 2013 Jun;27(6):580-5.
PubMed 23909073Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
PubMed 25501695
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial
- ClinicalTrials.gov ID
- NCT06788834
- Acronym / sponsor ID
- PROPOSE-RCT / PNRR-MCNT2-2023-12378183
- Conditions
- Cancer Surgery
- Keywords
- Prehabilitation, Functional recovery, Relaxation, Exercise, Diet, Nutrition, Functional walking, Hospital stay
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Prof. Pasquale Sansone, Prof. Eugenio Garofalo, Prof. Tiziana Bove, Dr. Claudia Brusasco, Prof. Gabriele Baldini, Dr. Nicola Passuello, Dr. Monica Gualtierotti, Prof. Luca Carlo Nespoli
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 Jan 2025 (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 PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.
The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.
Detailed description
The standard treatment for most solid cancer includes surgery and concurrent medical therapies, both of which have been shown to significantly improve prognosis. However, cancer treatments impose impactful physiological stress and have detrimental effects on acute and long-term health outcomes.
Physical, nutritional, and mental status can influence surgical outcomes, functional recovery and quality of life throughout the course of the disease.
The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period provides a unique opportunity to address comorbidities and modifiable risk factors. In addition, the metabolic stress induced by neoadjuvant therapy has been documented to frequently result in muscle atrophy and diminished functional capacity. The recognition that selected risk factors of poor postoperative outcome can be modified has prompted clinicians to identify proactive interventions to facilitate the recovery process. In this context, prehabilitation, aimed at enhancing the patients' functional capacity to enable them to withstand the physiological stress of surgery, has emerged as a promising approach. Although the term prehabilitation is not novel, the concept of optimizing patients before acute stressor or treatment has gained attention over the last decade. Nonetheless, quantifiable evidence of its effectiveness has yet to be fully demonstrated.
This study is a multicenter randomized controlled trial to assess the efficacy of personalized procedure-specific prehabilitation programs on patient-centered surgical outcomes. A total of 400 patients will be recruited by systematic screening of patients scheduled for elective surgical procedures. All patients undergoing elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery undergoing major cancer surgery will be screened for eligibility and those who meet the inclusion/exclusion criteria will be approached for consent. Research personnel will use a web-based randomization system to assign patients (1:1 ratio) to either the prehabilitation or control arm. Study personnel will also collect data on recruitment rates, with reasons for non-enrolment.
Eligible patients will be randomly assigned to 1 of 2 treatments:
- multimodal prehabilitation program for at least three weeks started as soon as possible before surgery;
- standard care.
The multimodal prehabilitation program will be individualized by carefully integrating and adapting various components to meet individual needs. The program will last at least three weeks (plus maintenance in case of delayed surgery), and will incorporate exercise training, nutritional therapy, and anxiety reduction techniques. After enrollment, patients will receive initial contact from trained personnel through telemedicine. To ensure personalized care, a comprehensive assessment will be conducted to identify specific physical, nutritional, or psychological challenges. Based on this assessment, a customized intervention plan will be prescribed to achieve tailored exercise training, optimized nutrition, and effective distress-coping strategies. All patients will be reassessed the day before surgery and 30 days after surgery. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, nutrition optimization, or distress-coping techniques-or a combination of these
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Multimodal prehabilitation ProgramThe prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery). |
| Control group | No intervention | –Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (age > 18 years);
- Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
- Signed informed consent.
Key exclusion criteria (8 listed)
- Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
- Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
- Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
- American Society of Anesthesiologists (ASA) physical status classes 4-5;
- Disabling orthopedic and neuromuscular disease;
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 |
|---|---|---|
| Multimodal prehabilitation ProgramA tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effects. The duration of the program will be set at a minimum of three weeks. | Behavioural | Prehabilitation |
Primary outcome
Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
Time frame: 30 days after surgery
The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification
6 secondary outcomes
Time to Functional Recovery (TFR)
Time frame: 30 days after surgery
Lenght of hospital stay (LOS)
Time frame: 30 days after surgery
Days at home up to 30 days after surgery (DAH-30)
Time frame: 30 days after surgery
Complication severity
Time frame: 30 days after surgery
Proportion of patients returning to preoperative functional walking capacity
Time frame: 30 days after surgery
Self-reported activity status and generic health related quality of life
Time frame: 30 days after surgery
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 7 Aug 2025.
- Background: PubMed 29262307Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.
- Background: PubMed 29452805Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
- Background: 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.
- Background: PubMed 23756434Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
- Background: PubMed 23909073Lemanne D, Cassileth B, Gubili J. The role of physical activity in cancer prevention, treatment, recovery, and survivorship. Oncology (Williston Park). 2013 Jun;27(6):580-5.
- Background: PubMed 25501695Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
- 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.
Marina Pieri, Medical Doctor principal investigator
IRCCS Ospedale San Raffaele
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation Program in people with Cancer Surgery, run by Università Vita-Salute San Raffaele at 9 sites in Italy.
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 3 inclusion and 8 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. 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 Marina LG Pieri, Medical Doctor (+393334625052, pieri.marina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery (time frame: 30 days after surgery). 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 NCT06788834, which also lists 6 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 7 Aug 2025.