Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
NCT ID: NCT04400552
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
91 participants
INTERVENTIONAL
2018-12-26
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery
NCT04347772
Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery
NCT03315195
Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery
NCT06825221
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
NCT06128798
Fast Track Recovery Surgery Among Gynecologic Oncology Patients
NCT03667755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The specific objectives are:
1. To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status
4. To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay
Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.
Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ONS Pre-op + ONS Post-op
Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital
ONS Pre-op + ONS Post-op
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
ONS Pre-op + ONS Post-op + ONS Post-op 3 months
Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months
ONS Pre-op + ONS Post-op + ONS Post-op 3 months
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
Usual intake Pre-op + ONS Post-op
Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital
Usual intake Pre-op + ONS Post-op
Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ONS Pre-op + ONS Post-op
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
ONS Pre-op + ONS Post-op + ONS Post-op 3 months
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
Usual intake Pre-op + ONS Post-op
Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 25 to 65 years
* BMI not less than 18.0 kg/m²
* Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
* Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.
Exclusion Criteria
* Pregnant or lactating
* On chemotherapy or radiotherapy
* Total gastrectomy or ileostomy
* Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
* On regular steroids prescription
25 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kotra Pharma (M) Sdn Bhd
UNKNOWN
IMU University, Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Winnie Chee
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Winnie SS Chee, PhD
Role: PRINCIPAL_INVESTIGATOR
IMU University, Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
International Medical University
Kuala Lumpur, , Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wong TX, Chen ST, Ong SH, Shyam S, Kandasami P, Chee WSS. Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMU R204/2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.