Colorectal NeoplasmsNCT06128798
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
A study testing Oral Impact and Nutren Optimum in people with Colorectal Neoplasms, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Oral Impact and Nutren Optimum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Sep 2023to 25 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is at least 18 years old
- All cases posted for Laparoscopic elective colorectal surgery
Who cannot join
- Known allergy to milk, fish, and soy.
- On fluid restriction
- Emergency Surgery
- Minor Age < 18 years old
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Manivaasan Pannirselvam, Dr, +60102258767, manivaasan.p@student.usm.my
Wong Pak Kai ( Michael ), Dr, +609-7676779, michaelpkwong@usm.my
About this study
Official title: A Randomized Controlled Trial on Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.
The main questions it aims to answer are:
Read more
- Does immunonutrition preoperatively facilitate earlier return of Gastrointestinal function?
- Does immunonutrition significantly reduce risk of post-operative surgical site infections?
- Does immunonutrition significantly reduce duration of hospital stay in patients undergoing colorectal surgery?
Immunonutrition can be defined as modulation of either the activity of the immune system, or modulation of the consequences of activation of the immune system, by nutrients or specific food items fed in amounts above those normally encountered in the diet.
Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings.
Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.
Partipicant will be randomised into this two arm and then they will consume the respective arm study material for total of 7 days preoperatively.
Data will be collected in post operative period and will be analysed.
Read the detailed description
Colorectal cancer (CRC) is the commonest cancer in Malaysian men and the second most common cancer in Malaysian women, accounting for age standardized rate of 14.8 and 11.1 incidences per 100,000 population respectively.
Oncological colonic resection is one of mainstay treatment modality for colorectal tumour. Major surgery precipitate release of stress hormones, inflammatory mediators and metabolic changes resulting in significant catabolic phenomena. This sequentially imposed significant dysfunction of the overall host homeostasis, defence mechanism and inflammatory response. Hence, the major setbacks of colorectal surgery are delay return of normal bowel physiology state, post-operative complications and prolonged hospital stay. This affects patients physiologically and psychologically.
Traditionally , patients undergo major abdominal surgery will be kept nil per oral for 6 to 12 hours prior to operation. Post operatively, parenteral or enteral fluids given until bowel function returns to normal. Fortunately, the introduction of the Enhanced Recovery After Surgery (ERAS) programs in last decade has led to enhanced in the recovery of patients postoperatively. The main aspects of substantial improvements in the care of postoperative patients include early initiation of oral intake as soon as possible, integration of nutrition support ,metabolic control and early mobilisation.
As nutritional status plays a significant role to influence the clinical outcomes, nutrition support has been widely used for elective colorectal surgery patients. Literature reported that nutritional risk rate of cancer patients to be 26% to 76 %, higher than of general patients.
Immunonutrition has been used as therapeutic options for peri-operative nutritional management in patients undergoing surgery. The nutrients of immunonutrition formula usually include arginine, omega-3 fatty acids, glutamine and nucleotides.
The current international guidelines recommend that patient's with high risk of malnutrition should be given immunonutrition in perioperative period prior to major oncologic surgeries.These guidelines are based on randomized controlled trials demonstrating a reduction in the rate of post-operative complications.
Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings. It comes in sachet form which mixed with water prior to consumption. Multiple randomised controlled trial supported Oral IMPACT as immunonutrition.
Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.
In nutshell , it is important for proper perioperative nutritional support for patients scheduled for colorectal surgery. It remain as major advantage for successful procedure.
In the light of this guideline investigators aimed to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.
- Conditions
- Colorectal Neoplasms
- Being tested
- Oral Impact, Nutren Optimum
- Keywords
- Immunonutrition, Colorectal Cancer, Oral Impact
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ImpactDietary supplement
A serving of 74 gm (containing 309 kcal ) of oral impact mixed with 250 ml of water. Each participant will receive total of 3 servings daily for 7 days pre operatively .
Nutren OptimumDietary supplement
A serving of 66.8 gm ( containing 304 kcal ) of nutren optimum mixed with 300 ml of water.Each participant will receive total of 3 servings daily for 7 days pre operatively .
| Study group | Role | What they receive |
|---|---|---|
| Oral Impact | Experimental | Immunonutrition enriched with omega-3 fatty acids, arginine, nucleotides, and soluble fibre. Main source of protein is arginine and casein. Receives: Dietary Supplement: Oral Impact |
| Nutren Optimum | Active comparator | A balanced nutritional supplement that enhance body natural defence and support recovery during illness. Receives: Dietary Supplement: Nutren Optimum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiology Return of Bowel Function
To compare the time of the first flatus and first bowel evacuation between Oral Impact® and Nutren Optimum ® when consumed in the preoperative in those undergoing colorectal surgery.
Measured: Through study completion , an average of 1 year
Secondary outcomes (2)
Surgical Site Infection
To associate the difference on post operative surgical site infection in between those consuming Oral Impact® versus Nutren Optimum ® in the preoperative period after colorectal surgery.
Measured: 30 days post operative period
Length of Hospital Stay
To study on the differences on duration of hospital stay after colorectal surgery in those consuming Oral Impact® and Nutren Optimum ®
Measured: From date of admission until patient is discharged back home or date of death from any cause during admission , whichever come first ,accessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start26 Sep 2023
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manivaasan Pannirselvam, Hospital Universiti Sains Malaysia
- Investigators
- Siti Rahmah Binti Hashim Isa Merican, Dr, Study director, Hospital Universiti Sains MalaysiaMuhammad Faeid BIn Othman, Dr, Study director, Hospital Universiti Sains MalaysiaManivaasan Pannirselvam, Dr, Principal investigator, Hospital Universiti Sains MalaysiaNor Syarahani Binti Jusoh, Dr, Study director, Hospital Universiti Sains MalaysiaWong Pak Kai ( Michael), Dr, Study director, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128798
- Sponsor's protocol ID
- USM/JEPeM/KK/23050402
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Shaikh SR, Jolly CA, Chapkin RS. n-3 Polyunsaturated fatty acids exert immunomodulatory effects on lymphocytes by targeting plasma membrane molecular organization. Mol Aspects Med. 2012 Feb;33(1):46-54. doi: 10.1016/j.mam.2011.10.002. Epub 2011 Oct 19.
PubMed 22020145Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
PubMed 15896435Lee SY, Jung MR, Kim CH, Kim YJ, Kim HR. Nutritional risk screening score is an independent predictive factor of anastomotic leakage after rectal cancer surgery. Eur J Clin Nutr. 2018 Apr;72(4):489-495. doi: 10.1038/s41430-018-0112-3. Epub 2018 Feb 19.
PubMed 29459787Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
PubMed 28385477Chang HR, Bistrian B. The role of cytokines in the catabolic consequences of infection and injury. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):156-66. doi: 10.1177/0148607198022003156.
PubMed 9586794Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.
PubMed 24178185Grimble RF. Basics in clinical nutrition: Immunonutrition - Nutrients which influence immunity: Effect and mechanism of action. Vol. 4, e-SPEN. Elsevier BV; 2009.
Xiong L, Teng JL, Botelho MG, Lo RC, Lau SK, Woo PC. Arginine Metabolism in Bacterial Pathogenesis and Cancer Therapy. Int J Mol Sci. 2016 Mar 11;17(3):363. doi: 10.3390/ijms17030363.
PubMed 26978353Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
PubMed 12464864Hess JR, Greenberg NA. The role of nucleotides in the immune and gastrointestinal systems: potential clinical applications. Nutr Clin Pract. 2012 Apr;27(2):281-94. doi: 10.1177/0884533611434933. Epub 2012 Mar 5.
PubMed 22392907Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
PubMed 12352035Cruzat V, Macedo Rogero M, Noel Keane K, Curi R, Newsholme P. Glutamine: Metabolism and Immune Function, Supplementation and Clinical Translation. Nutrients. 2018 Oct 23;10(11):1564. doi: 10.3390/nu10111564.
PubMed 30360490
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT06128798
- Acronym / sponsor ID
- USM/JEPeM/KK/23050402
- Conditions
- Colorectal Neoplasms
- Keywords
- Immunonutrition, Colorectal Cancer, Oral Impact
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 13 Nov 2023 (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.
This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.
The main questions it aims to answer are:
- Does immunonutrition preoperatively facilitate earlier return of Gastrointestinal function?
- Does immunonutrition significantly reduce risk of post-operative surgical site infections?
- Does immunonutrition significantly reduce duration of hospital stay in patients undergoing colorectal surgery?
Immunonutrition can be defined as modulation of either the activity of the immune system, or modulation of the consequences of activation of the immune system, by nutrients or specific food items fed in amounts above those normally encountered in the diet.
Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings.
Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.
Partipicant will be randomised into this two arm and then they will consume the respective arm study material for total of 7 days preoperatively.
Data will be collected in post operative period and will be analysed.
Detailed description
Colorectal cancer (CRC) is the commonest cancer in Malaysian men and the second most common cancer in Malaysian women, accounting for age standardized rate of 14.8 and 11.1 incidences per 100,000 population respectively.
Oncological colonic resection is one of mainstay treatment modality for colorectal tumour. Major surgery precipitate release of stress hormones, inflammatory mediators and metabolic changes resulting in significant catabolic phenomena. This sequentially imposed significant dysfunction of the overall host homeostasis, defence mechanism and inflammatory response. Hence, the major setbacks of colorectal surgery are delay return of normal bowel physiology state, post-operative complications and prolonged hospital stay. This affects patients physiologically and psychologically.
Traditionally , patients undergo major abdominal surgery will be kept nil per oral for 6 to 12 hours prior to operation. Post operatively, parenteral or enteral fluids given until bowel function returns to normal. Fortunately, the introduction of the Enhanced Recovery After Surgery (ERAS) programs in last decade has led to enhanced in the recovery of patients postoperatively. The main aspects of substantial improvements in the care of postoperative patients include early initiation of oral intake as soon as possible, integration of nutrition support ,metabolic control and early mobilisation.
As nutritional status plays a significant role to influence the clinical outcomes, nutrition support has been widely used for elective colorectal surgery patients. Literature reported that nutritional risk rate of cancer patients to be 26% to 76 %, higher than of general patients.
Immunonutrition has been used as therapeutic options for peri-operative nutritional management in patients undergoing surgery. The nutrients of immunonutrition formula usually include arginine, omega-3 fatty acids, glutamine and nucleotides.
The current international guidelines recommend that patient's with high risk of malnutrition should be given immunonutrition in perioperative period prior to major oncologic surgeries.These guidelines are based on randomized controlled trials demonstrating a reduction in the rate of post-operative complications.
Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings. It comes in sachet form which mixed with water prior to consumption. Multiple randomised controlled trial supported Oral IMPACT as immunonutrition.
Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.
In nutshell , it is important for proper perioperative nutritional support for patients scheduled for colorectal surgery. It remain as major advantage for successful procedure.
In the light of this guideline investigators aimed to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Impact | Experimental | Dietary Supplement: Oral ImpactImmunonutrition enriched with omega-3 fatty acids, arginine, nucleotides, and soluble fibre. Main source of protein is arginine and casein. |
| Nutren Optimum | Active comparator | Dietary Supplement: Nutren OptimumA balanced nutritional supplement that enhance body natural defence and support recovery during illness. |
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 is at least 18 years old
- All cases posted for Laparoscopic elective colorectal surgery
Key exclusion criteria (4 listed)
- Known allergy to milk, fish, and soy.
- On fluid restriction
- Emergency Surgery
- Minor Age < 18 years old
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 |
|---|---|---|
| Oral ImpactA serving of 74 gm (containing 309 kcal ) of oral impact mixed with 250 ml of water. Each participant will receive total of 3 servings daily for 7 days pre operatively . | Dietary supplement | Oral Impact |
| Nutren OptimumA serving of 66.8 gm ( containing 304 kcal ) of nutren optimum mixed with 300 ml of water.Each participant will receive total of 3 servings daily for 7 days pre operatively . | Dietary supplement | Nutren Optimum |
Primary outcome
Physiology Return of Bowel Function
Time frame: Through study completion , an average of 1 year
To compare the time of the first flatus and first bowel evacuation between Oral Impact® and Nutren Optimum ® when consumed in the preoperative in those undergoing colorectal surgery.
2 secondary outcomes
Surgical Site Infection
Time frame: 30 days post operative period
Length of Hospital Stay
Time frame: From date of admission until patient is discharged back home or date of death from any cause during admission , whichever come first ,accessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 22020145Shaikh SR, Jolly CA, Chapkin RS. n-3 Polyunsaturated fatty acids exert immunomodulatory effects on lymphocytes by targeting plasma membrane molecular organization. Mol Aspects Med. 2012 Feb;33(1):46-54. doi: 10.1016/j.mam.2011.10.002. Epub 2011 Oct 19.
- Results publication: PubMed 15896435Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
- Results publication: PubMed 29459787Lee SY, Jung MR, Kim CH, Kim YJ, Kim HR. Nutritional risk screening score is an independent predictive factor of anastomotic leakage after rectal cancer surgery. Eur J Clin Nutr. 2018 Apr;72(4):489-495. doi: 10.1038/s41430-018-0112-3. Epub 2018 Feb 19.
- Results publication: PubMed 28385477Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
- Results publication: PubMed 9586794Chang HR, Bistrian B. The role of cytokines in the catabolic consequences of infection and injury. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):156-66. doi: 10.1177/0148607198022003156.
- Results publication: PubMed 24178185Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.
- Results publicationGrimble RF. Basics in clinical nutrition: Immunonutrition - Nutrients which influence immunity: Effect and mechanism of action. Vol. 4, e-SPEN. Elsevier BV; 2009.
- Results publication: PubMed 26978353Xiong L, Teng JL, Botelho MG, Lo RC, Lau SK, Woo PC. Arginine Metabolism in Bacterial Pathogenesis and Cancer Therapy. Int J Mol Sci. 2016 Mar 11;17(3):363. doi: 10.3390/ijms17030363.
- Results publication: PubMed 12464864Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
- Results publication: PubMed 22392907Hess JR, Greenberg NA. The role of nucleotides in the immune and gastrointestinal systems: potential clinical applications. Nutr Clin Pract. 2012 Apr;27(2):281-94. doi: 10.1177/0884533611434933. Epub 2012 Mar 5.
- Results publication: PubMed 12352035Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
- Results publication: PubMed 30360490Cruzat V, Macedo Rogero M, Noel Keane K, Curi R, Newsholme P. Glutamine: Metabolism and Immune Function, Supplementation and Clinical Translation. Nutrients. 2018 Oct 23;10(11):1564. doi: 10.3390/nu10111564.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Siti Rahmah Binti Hashim Isa Merican, Dr study director
Hospital Universiti Sains Malaysia
Muhammad Faeid BIn Othman, Dr study director
Hospital Universiti Sains Malaysia
Manivaasan Pannirselvam, Dr principal investigator
Hospital Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Impact and Nutren Optimum in people with Colorectal Neoplasms, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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 4 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 13 Nov 2023. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manivaasan Pannirselvam, Dr (+60102258767, manivaasan.p@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiology Return of Bowel Function (time frame: Through study completion , an average of 1 year). 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 NCT06128798, which also lists 12 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 13 Nov 2023.