SarcopeniaNCT04306562
Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients
A study testing enteral nutrition supplement in people with Sarcopenia and Cancer, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Sarcopenia is a condition of reduced skeletal muscle associated with aging. It leads to poor outcome and increased risk of postoperative complications. Achieving protein and energy requirements is crucial point in sarcopenia treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Cancer
- What is being tested?
- enteral nutrition supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2019to 28 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age of equal or more than 65 years.
- Diagnosed cancer of gastrointestinal tract, hepatopancreaticobiliary tract, urology, head and neck, ear-nose-throat or gynecological cancer.
- Scheduled for elective surgery with the duration more than 2 hours will be enrolled in this study.
Who cannot join
- Unable to walk, stand up, perform hand grip test, communicate and follow commands.
- Having factors affect bioimpedance (BIA) analysis such as pacemaker, alcohol drinking or heavy exercise within 12 hours prior to analysis or take medication, herb or hormone that affect muscle mass and strength such as estrogen, testosterone, thyroxine, steroid.
- Patients diagnosed with no sarcopenia or probable sarcopenia or have a contraindication for enteral nutrition will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients: A Randomized Controlled Trial
Sarcopenia is a condition of reduced skeletal muscle associated with aging. It leads to poor outcome and increased risk of postoperative complications. Achieving protein and energy requirements is crucial point in sarcopenia treatment. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis.
The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.
Read the detailed description
Sarcopenia is a condition of reduced skeletal muscle mass associated with aging process leading to decrease muscle strength and function. International Working Group on Sarcopenia defines Sarcopenia as an age-associated loss of skeletal muscle mass and function, and the European Working Group on Sarcopenia in Older People (EWGSOP) defines sarcopenia as a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. The prevalence of sarcopenia is higher in population older than 65 years and leading to poor outcomes such as mobility disorders, disability, poor quality of life and death. Sarcopenia is also associated with an increased risk of postoperative complications such as overgrowth of bacteria in the gastrointestinal tract, postoperative infections, sepsis, delayed wound healing prolonged inpatient rehabilitation, mortality and consequently a longer length of hospital stay, even without nutritional risk.
Sarcopenia contains multifactorial etiology, such as age-related, inadequate energy and/or protein intake, sedentary activity such as bed rest, and coexisting disease such as organ failure, inflammatory disease or endocrine disease. One important goal of developing treatment strategies in sarcopenic patients is to achieve protein and energy requirements. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis. Perioperative oral protein supplements have been demonstrated to increase serum albumin and total protein, improve postoperative functional walking capacity and decrease postoperative infection in elderly or critically ill patients. However, there have been no studies on the benefit of preoperative protein supplement in cancerous patients.
The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.
- Conditions
- Sarcopenia, Cancer
- Being tested
- enteral nutrition supplement
- Keywords
- Protein supplementation, Perioperative
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition supplementDietary supplement
enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day for at least 14 days from a preanesthetic clinic visit to a day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in an intervention group will be ask about a history of food consumption in the past seven days to analyze a nutritive value of food consumption with a program (INMUCAL-Nutrients V.4.0, Institute of Nutrition, Mahidol University) and estimate an enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day with nutritional counseling by researchers. Special enteral formula will be selected if patients have specific conditions including renal failure, hyperglycemia/diabetes and liver failure, acute and chronic pulmonary disease and immunocompromised states. Otherwise, standard formula will be provided. Duration of enteral protein supplementation is at least 14 days from a preanesthetic clinic visit to a day of surgery. Receives: Dietary Supplement: enteral nutrition supplement |
| Control group | No intervention | Patients in a control group will be sent to assess and improve nutritional status by primary doctor as a conventional care pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
postoperative complications within 30 days after operation which will be recorded and classify into surgical or non-surgical complications. All complication will be graded using Dindo-Clavien classification into 5 grades; Grade I is any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II is complication which requiring pharmacological treatment with drugs (other than such allowed for grade I), blood transfusions or total parenteral nutrition are also included; Grade III requires surgical, endoscopic or radiological intervention; Grade IV is life-threatening complication (including CNS complications) requiring ICU management; Grade V means death of a patient.
Measured: 30 days after operation
Secondary outcomes (2)
mortality rate
number of patient death within 90 days after operation of elective surgery
Measured: 90 days after operation
duration of hospital admission
duration of hospital admission record in days.
Measured: through patients discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Oct 2019
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Why it stopped: The clinical study was terminated prior to completion due to challenges in enrolling a sufficient number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients who were diagnosed with sarcopenia or severe sarcopenia, will be randomly assigned following stratified randomization procedures (computerized random numbers) to one of two groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306562
- Sponsor's protocol ID
- IRB632
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2020
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.
PubMed 21527165Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
PubMed 31081853Cruz-Jentoft AJ, Landi F, Topinkova E, Michel JP. Understanding sarcopenia as a geriatric syndrome. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):1-7. doi: 10.1097/MCO.0b013e328333c1c1.
PubMed 19915458Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.
PubMed 29373365Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.
PubMed 24651133Kuwada K, Kuroda S, Kikuchi S, Yoshida R, Nishizaki M, Kagawa S, Fujiwara T. Sarcopenia and Comorbidity in Gastric Cancer Surgery as a Useful Combined Factor to Predict Eventual Death from Other Causes. Ann Surg Oncol. 2018 May;25(5):1160-1166. doi: 10.1245/s10434-018-6354-4. Epub 2018 Feb 5.
PubMed 29404820Friedman J, Lussiez A, Sullivan J, Wang S, Englesbe M. Implications of sarcopenia in major surgery. Nutr Clin Pract. 2015 Apr;30(2):175-9. doi: 10.1177/0884533615569888. Epub 2015 Feb 13.
PubMed 25681482Ma BW, Chen XY, Fan SD, Zhang FM, Huang DD, Li B, Shen X, Zhuang CL, Yu Z. Impact of sarcopenia on clinical outcomes after radical gastrectomy for patients without nutritional risk. Nutrition. 2019 May;61:61-66. doi: 10.1016/j.nut.2018.10.025. Epub 2018 Oct 24.
PubMed 30703570Lieffers JR, Bathe OF, Fassbender K, Winget M, Baracos VE. Sarcopenia is associated with postoperative infection and delayed recovery from colorectal cancer resection surgery. Br J Cancer. 2012 Sep 4;107(6):931-6. doi: 10.1038/bjc.2012.350. Epub 2012 Aug 7.
PubMed 22871883
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04306562
- Acronym / sponsor ID
- IRB632
- Conditions
- Sarcopenia, Cancer
- Keywords
- Protein supplementation, Perioperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study was terminated prior to completion due to challenges in enrolling a sufficient number of participants.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 13 Mar 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.
Sarcopenia is a condition of reduced skeletal muscle associated with aging. It leads to poor outcome and increased risk of postoperative complications. Achieving protein and energy requirements is crucial point in sarcopenia treatment. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis.
The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.
Detailed description
Sarcopenia is a condition of reduced skeletal muscle mass associated with aging process leading to decrease muscle strength and function. International Working Group on Sarcopenia defines Sarcopenia as an age-associated loss of skeletal muscle mass and function, and the European Working Group on Sarcopenia in Older People (EWGSOP) defines sarcopenia as a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. The prevalence of sarcopenia is higher in population older than 65 years and leading to poor outcomes such as mobility disorders, disability, poor quality of life and death. Sarcopenia is also associated with an increased risk of postoperative complications such as overgrowth of bacteria in the gastrointestinal tract, postoperative infections, sepsis, delayed wound healing prolonged inpatient rehabilitation, mortality and consequently a longer length of hospital stay, even without nutritional risk.
Sarcopenia contains multifactorial etiology, such as age-related, inadequate energy and/or protein intake, sedentary activity such as bed rest, and coexisting disease such as organ failure, inflammatory disease or endocrine disease. One important goal of developing treatment strategies in sarcopenic patients is to achieve protein and energy requirements. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis. Perioperative oral protein supplements have been demonstrated to increase serum albumin and total protein, improve postoperative functional walking capacity and decrease postoperative infection in elderly or critically ill patients. However, there have been no studies on the benefit of preoperative protein supplement in cancerous patients.
The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who were diagnosed with sarcopenia or severe sarcopenia, will be randomly assigned following stratified randomization procedures (computerized random numbers) to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: enteral nutrition supplementPatients in an intervention group will be ask about a history of food consumption in the past seven days to analyze a nutritive value of food consumption with a program (INMUCAL-Nutrients V.4.0, Institute of Nutrition, Mahidol University) and estimate an enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day with nutritional counseling by researchers. Special enteral formula will be selected if patients have specific conditions including renal failure, hyperglycemia/diabetes and liver failure, acute and chronic pulmonary disease and immunocompromised states. Otherwise, standard formula will be provided. Duration of enteral protein supplementation is at least 14 days from a preanesthetic clinic visit to a day of surgery. |
| Control group | No intervention | –Patients in a control group will be sent to assess and improve nutritional status by primary doctor as a conventional care pathway. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age of equal or more than 65 years.
- Diagnosed cancer of gastrointestinal tract, hepatopancreaticobiliary tract, urology, head and neck, ear-nose-throat or gynecological cancer.
- Scheduled for elective surgery with the duration more than 2 hours will be enrolled in this study.
Key exclusion criteria (3 listed)
- Unable to walk, stand up, perform hand grip test, communicate and follow commands.
- Having factors affect bioimpedance (BIA) analysis such as pacemaker, alcohol drinking or heavy exercise within 12 hours prior to analysis or take medication, herb or hormone that affect muscle mass and strength such as estrogen, testosterone, thyroxine, steroid.
- Patients diagnosed with no sarcopenia or probable sarcopenia or have a contraindication for enteral nutrition will be excluded from this study.
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 |
|---|---|---|
| enteral nutrition supplemententeral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day for at least 14 days from a preanesthetic clinic visit to a day of surgery. | Dietary supplement | Intervention group |
Primary outcome
Postoperative complications
Time frame: 30 days after operation
postoperative complications within 30 days after operation which will be recorded and classify into surgical or non-surgical complications. All complication will be graded using Dindo-Clavien classification into 5 grades; Grade I is any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II is complication which requiring pharmacological treatment with drugs (other than such allowed for grade I), blood transfusions or total parenteral nutrition are also included; Grade III requires surgical, endoscopic or radiological intervention; Grade IV is life-threatening complication (including CNS complications) requiring ICU management; Grade V means death of a patient.
2 secondary outcomes
mortality rate
Time frame: 90 days after operation
duration of hospital admission
Time frame: through patients discharge, an average of 1 week
Results and safety
The study was stopped early (reason given: The clinical study was terminated prior to completion due to challenges in enrolling a sufficient number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 21527165Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.
- Background: PubMed 31081853Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
- Background: PubMed 19915458Cruz-Jentoft AJ, Landi F, Topinkova E, Michel JP. Understanding sarcopenia as a geriatric syndrome. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):1-7. doi: 10.1097/MCO.0b013e328333c1c1.
- Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
- Background: PubMed 29373365Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.
- Background: PubMed 24651133Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.
- Background: PubMed 29404820Kuwada K, Kuroda S, Kikuchi S, Yoshida R, Nishizaki M, Kagawa S, Fujiwara T. Sarcopenia and Comorbidity in Gastric Cancer Surgery as a Useful Combined Factor to Predict Eventual Death from Other Causes. Ann Surg Oncol. 2018 May;25(5):1160-1166. doi: 10.1245/s10434-018-6354-4. Epub 2018 Feb 5.
- Background: PubMed 25681482Friedman J, Lussiez A, Sullivan J, Wang S, Englesbe M. Implications of sarcopenia in major surgery. Nutr Clin Pract. 2015 Apr;30(2):175-9. doi: 10.1177/0884533615569888. Epub 2015 Feb 13.
- Background: PubMed 30703570Ma BW, Chen XY, Fan SD, Zhang FM, Huang DD, Li B, Shen X, Zhuang CL, Yu Z. Impact of sarcopenia on clinical outcomes after radical gastrectomy for patients without nutritional risk. Nutrition. 2019 May;61:61-66. doi: 10.1016/j.nut.2018.10.025. Epub 2018 Oct 24.
- Background: PubMed 22871883Lieffers JR, Bathe OF, Fassbender K, Winget M, Baracos VE. Sarcopenia is associated with postoperative infection and delayed recovery from colorectal cancer resection surgery. Br J Cancer. 2012 Sep 4;107(6):931-6. doi: 10.1038/bjc.2012.350. Epub 2012 Aug 7.
- 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. This study is not recruiting at the moment.
Mingkwan Wongyingsinn principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition supplement in people with Sarcopenia and Cancer, run by Siriraj Hospital at 1 site in Thailand.
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 3 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: stopped early, as of the sponsor's last update on 29 Mar 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 Thailand. 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 was stopped early (reason given: The clinical study was terminated prior to completion due to challenges in enrolling a sufficient number of participants.). 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?
Postoperative complications (time frame: 30 days after operation). 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 NCT04306562, which also lists 10 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 Mar 2024.