SarcopeniaNCT05491434
Sarcopenia in Colorectal Cancer Patients, Intervention Study
A study testing Protein supplement in people with Sarcopenia and Postoperative Complications, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia, Postoperative Complications, Infection;Post Surg Procedure
- What is being tested?
- Protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 31 Jan 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years old,
- Colon adenocarcinoma without synchronous metàstasis,
- No urgent surgery,
- ECOG performance status ≤ 2,
- no pregnancy or lactation,
- signature of the informed consent,
- ability to comply with the study indications.
Who cannot join
- rectal càncer,
- Concomitant neoplastic disease in the last 5 years
- medical or mental condition of the patient that compromises the authorization of informed consent,
- Concomitant uncontrolled or stable medical condition,
- Clinically significant heart disease (congestive heart failure, symptomatic coronary disease)
- Refusal to participate in the study.
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 Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08709
Ricardo Frago, Ph D, +34932607485, rfrago@bellvitgehospital.cat
About this study
Official title: Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia
The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases.
The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.
Read the detailed description
CONCEPTUAL HYPOTHESIS Improving functional status through physical exercise and nutritional supplementation of sarcopenic colon cancer patients at diagnosis can reduce the rate of infectious complications after surgery.
OPERATIONAL HYPOTHESIS Active preoperative preparation of sarcopenic colon cancer patients reduces post-surgical infectious complications by at least 11%, reaching a rate similar to patients without initial sarcopenia.
Inclusion criteria: - Age ≥ 70 years old; - Colon adenocarcinoma without synchronous metastases; - No urgent surgery; - ECOG performance status ≤ 2 .; - no pregnancy or lactation .; - signature of the informed consent; - ability to comply with the study indications. Exclusion criteria: - rectal cancer; - Concomitant neoplastic disease in the last 5 years - medical or mental condition of the patient that compromises the authorization of informed consent; - Concomitant uncontrolled or stable medical condition; - Clinically significant heart disease (congestive heart failure, symptomatic coronary disease) - Refusal to participate in the study.
Study variable (categorization of patients): Evaluation of Sarcopenia: it will be performed by CT, identifying the image of L3 (3rd lumbar vertebra). Main outcome variable: Cumulative incidence of post-surgical complications due to infection at 30 days.
Secondary variables: Frailty, Immune status, Quality of life (QoL) C30 and CR29 INTRVENTION (study groups)
- ARM A (Control: No sarcopenia): the usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity.
- ARM B (Experimental: Sarcopenia): in addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks.
- Being tested
- Protein supplement
- Keywords
- Sarcopenia, Colon cancer, Postoperative complications, Inmunologic status, L3 CT image
- Medical subject headings
- Sarcopenia, Postoperative Complications, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementDietary supplement
Also called 10gr protein/100 ml. Every liquid brick have 200 ml
One líquid brick every day during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity |
| Experimental | Experimental | In addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks. Receives: Dietary Supplement: Protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients
Evaluate the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise in the latter group
Measured: 30 days
Secondary outcomes (3)
To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients
All complications, not just infectious
Measured: 30 days
Overall survival at one year
To study survival one year after surgery in patients considered preoperatively as having sarcopenia.
Measured: One year
Quality of life of surgical patients
Evaluate the quality of life according the QLQ EORTC QlQ C-30 y ClQ CR29
Measured: At 3 months, 6 months and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Dec 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Frago Montanuy, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491434
- Sponsor's protocol ID
- PR137/19
- Status last verified
- May 2025
- First submitted
- 4 Aug 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia
- ClinicalTrials.gov ID
- NCT05491434
- Acronym / sponsor ID
- PR137/19
- Keywords
- Sarcopenia, Colon cancer, Postoperative complications, Inmunologic status, L3 CT image
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases.
The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.
Detailed description
CONCEPTUAL HYPOTHESIS Improving functional status through physical exercise and nutritional supplementation of sarcopenic colon cancer patients at diagnosis can reduce the rate of infectious complications after surgery.
OPERATIONAL HYPOTHESIS Active preoperative preparation of sarcopenic colon cancer patients reduces post-surgical infectious complications by at least 11%, reaching a rate similar to patients without initial sarcopenia.
Inclusion criteria: - Age ≥ 70 years old; - Colon adenocarcinoma without synchronous metastases; - No urgent surgery; - ECOG performance status ≤ 2 .; - no pregnancy or lactation .; - signature of the informed consent; - ability to comply with the study indications. Exclusion criteria: - rectal cancer; - Concomitant neoplastic disease in the last 5 years - medical or mental condition of the patient that compromises the authorization of informed consent; - Concomitant uncontrolled or stable medical condition; - Clinically significant heart disease (congestive heart failure, symptomatic coronary disease) - Refusal to participate in the study.
Study variable (categorization of patients): Evaluation of Sarcopenia: it will be performed by CT, identifying the image of L3 (3rd lumbar vertebra). Main outcome variable: Cumulative incidence of post-surgical complications due to infection at 30 days.
Secondary variables: Frailty, Immune status, Quality of life (QoL) C30 and CR29 INTRVENTION (study groups)
- ARM A (Control: No sarcopenia): the usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity.
- ARM B (Experimental: Sarcopenia): in addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity |
| Experimental | Experimental | Dietary Supplement: Protein supplementIn addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 70 years old,
- Colon adenocarcinoma without synchronous metàstasis,
- No urgent surgery,
- ECOG performance status ≤ 2,
- no pregnancy or lactation,
Key exclusion criteria (6 listed)
- rectal càncer,
- Concomitant neoplastic disease in the last 5 years
- medical or mental condition of the patient that compromises the authorization of informed consent,
- Concomitant uncontrolled or stable medical condition,
- Clinically significant heart disease (congestive heart failure, symptomatic coronary 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 |
|---|---|---|
| Protein supplementAlso: 10gr protein/100 ml. Every liquid brick have 200 mlOne líquid brick every day during 3 weeks | Dietary supplement | Experimental |
Primary outcome
to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients
Time frame: 30 days
Evaluate the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise in the latter group
3 secondary outcomes
To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients
Time frame: 30 days
Overall survival at one year
Time frame: One year
Quality of life of surgical patients
Time frame: At 3 months, 6 months and one year 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 20 May 2025.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplement in people with Sarcopenia and Postoperative Complications, run by Hospital Universitari de Bellvitge 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 7 inclusion and 6 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 20 May 2025. 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 Ricardo Frago, Ph D (+34932607485, rfrago@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients (time frame: 30 days). 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 20 May 2025.