Colo-rectal CancerPRERASNCT03618329
Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.
A study testing Prehabilitation in people with Colo-rectal Cancer and Nutrition Disorders, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Trial summary
The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Nutrition Disorders
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 30 Dec 2019
- 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
- It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program.
- The subject is ≥ 18 years of age.
- The subject can perform any of the two proposed treatments.
- Preoperative staging TxNxM0.
- The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study.
Who cannot join
- Patients with rectal cancer.
- The study doctor determines that the subject is not eligible to participate.
- The subject can not give informed consent to participate in the study.
- The subject can not perform the pre-habilitation.
- Non-acceptance or impossibility of following rehabilitation protocol multimodal
- The subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time
- Subjects who have received previous radiochemotherapy, HIV, gestational stage, psychiatric, with CRF who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, ASA IV, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control.
- Subject has renal or hepatic impairment (GFR <60ml / m or AST / ALT 3 x upper limit of normal).
About this study
Official title: Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.
The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.
- Conditions
- Colo-rectal Cancer, Nutrition Disorders
- Being tested
- Prehabilitation
- Keywords
- COLON CANCER, ERAS, NUTRITION
- Medical subject headings
- Colonic Neoplasms, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
exercise, nutrition and anxiety reduction in the preoperative period
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Active comparator | exercise, nutrition and anxiety reduction in the preoperative period Receives: Other: Prehabilitation |
| No Prehabilitation | No intervention | Not: exercise, nutrition and anxiety reduction in the preoperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of prehabilitation on the change from lean mass index
Effect of prehabilitation on the lean mass index
Measured: preoperative and 1-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
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 Colo-rectal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Arroyo Sebastian, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618329
- Sponsor's protocol ID
- PRERAS
- Acronym
- PRERAS
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Triguero-Canovas D, Lopez-Rodriguez-Arias F, Gomez-Martinez M, Sanchez-Guillen L, Peris-Castello F, Alcaide-Quiros MJ, Morillas-Blasco P, Arroyo A, Ramirez JM. Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. Support Care Cancer. 2023 Nov 6;31(12):673. doi: 10.1007/s00520-023-08140-4.
PubMed 37930478Lopez-Rodriguez-Arias F, Sanchez-Guillen L, Aranaz-Ostariz V, Triguero-Canovas D, Lario-Perez S, Barber-Valles X, Lacueva FJ, Ramirez JM, Arroyo A. Effect of home-based prehabilitation in an enhanced recovery after surgery program for patients undergoing colorectal cancer surgery during the COVID-19 pandemic. Support Care Cancer. 2021 Dec;29(12):7785-7791. doi: 10.1007/s00520-021-06343-1. Epub 2021 Jun 24.
PubMed 34169328
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.
- ClinicalTrials.gov ID
- NCT03618329
- Acronym / sponsor ID
- PRERAS / PRERAS
- Conditions
- Colo-rectal Cancer, Nutrition Disorders
- Keywords
- COLON CANCER, ERAS, NUTRITION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 7 Aug 2018 (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 implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Active comparator | Other: Prehabilitationexercise, nutrition and anxiety reduction in the preoperative period |
| No Prehabilitation | No intervention | –Not: exercise, nutrition and anxiety reduction in the preoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program.
- The subject is ≥ 18 years of age.
- The subject can perform any of the two proposed treatments.
- Preoperative staging TxNxM0.
- The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study.
Key exclusion criteria (8 listed)
- Patients with rectal cancer.
- The study doctor determines that the subject is not eligible to participate.
- The subject can not give informed consent to participate in the study.
- The subject can not perform the pre-habilitation.
- Non-acceptance or impossibility of following rehabilitation protocol multimodal
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 |
|---|---|---|
| Prehabilitationexercise, nutrition and anxiety reduction in the preoperative period | Other | Prehabilitation |
Primary outcome
Effect of prehabilitation on the change from lean mass index
Time frame: preoperative and 1-month postoperative
Effect of prehabilitation on the lean mass index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 37930478Triguero-Canovas D, Lopez-Rodriguez-Arias F, Gomez-Martinez M, Sanchez-Guillen L, Peris-Castello F, Alcaide-Quiros MJ, Morillas-Blasco P, Arroyo A, Ramirez JM. Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. Support Care Cancer. 2023 Nov 6;31(12):673. doi: 10.1007/s00520-023-08140-4.
- Derived from this study: PubMed 34169328Lopez-Rodriguez-Arias F, Sanchez-Guillen L, Aranaz-Ostariz V, Triguero-Canovas D, Lario-Perez S, Barber-Valles X, Lacueva FJ, Ramirez JM, Arroyo A. Effect of home-based prehabilitation in an enhanced recovery after surgery program for patients undergoing colorectal cancer surgery during the COVID-19 pandemic. Support Care Cancer. 2021 Dec;29(12):7785-7791. doi: 10.1007/s00520-021-06343-1. Epub 2021 Jun 24.
Related trials for Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Colo-rectal Cancer and Nutrition Disorders, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
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 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Effect of prehabilitation on the change from lean mass index (time frame: preoperative and 1-month postoperative). 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 NCT03618329, 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 7 Aug 2018.