Peri-operative oral immunonutrition in malnourished ovarian cancer patients assessed by the nutritional risk screening.
Linda Hertlein, Christine Zeder-Göß, Sophie Fürst...
https://pubmed.ncbi.nlm.nih.gov/29623417Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
FEMALE
ID06039306
Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
Led by Universiti Putra Malaysia · Updated on 2025-08-19
106
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on women with gynecological cancer who are undergoing elective surgery. The study aims to compare the effects of perioperative immunonutrition supplements on nutritional, functional, and postoperative outcomes under an Enhanced Recovery After Surgery (ERAS) program. Researchers seek to determine if this supplement can improve recovery compared to conventional care. Participants in the intervention group will receive two servings of immunonutrition supplements daily for five days before surgery and continue for seven days after surgery alongside the ERAS protocol. The conventional group will follow the usual diet before surgery and receive a polymeric formula only if unable to consume 75% of their hospital diet postoperatively. During the study, participants' energy and protein intake, body composition, immunoglobulin levels, C-reactive protein, postoperative outcomes, functional status, and stress levels will be monitored for one month. The trial is randomized and open-label, with follow-up assessments to evaluate the impact of immunonutrition on recovery after surgery.
CONDITIONS
Brief Title
Perioperative Immunonutrition Under Enhanced Recovery After Surgery
Who Can Participate
Age: 18Years - 80Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Diagnosed with gynecological cancer
- Scheduled for elective surgery
You will not qualify if you...
- Have gastrointestinal tract complications
- Have metastatic gynecological cancer
- Allergy to milk, soy, or whey protein
- Currently participating in another intervention study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 days
Participants take immunonutrition supplements starting 5 days before surgery and continuing for 7 days after surgery as part of the Enhanced Recovery After Surgery protocol.
1 baseline visit before surgery and daily intake for 12 days
Follow-up
Duration - 1 month
Participants are monitored for postoperative outcomes and recovery for up to 1 month after surgery.
Approximately 4 weekly visits
Trial Site Locations
Total: 1 location
1
Institut Kanser Negara
Putrajaya, Putrajaya, Malaysia, 62250
Actively Recruiting
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Research Team
C
ChiouYi Ho
Z
Zulfitri 'Azuan Mat Daud
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Enhanced recovery after surgery: Current research insights and future direction.
Aliza Abeles, Richard Mark Kwasnicki, Ara Darzi
https://pubmed.ncbi.nlm.nih.gov/28289508ESPEN guidelines on nutrition in cancer patients.
Jann Arends, Patrick Bachmann, Vickie Baracos...
https://pubmed.ncbi.nlm.nih.gov/27637832Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial.
Chiou Yi Ho, Zuriati Ibrahim, Zalina Abu Zaid...
https://pubmed.ncbi.nlm.nih.gov/35011097Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial.
Ho Chiou Yi, Zuriati Ibrahim, Zalina Abu Zaid...
https://pubmed.ncbi.nlm.nih.gov/31968595Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer.
L A Mudge, D I Watson, B M Smithers...
https://pubmed.ncbi.nlm.nih.gov/29999517Immunonutrients involved in the regulation of the inflammatory and oxidative processes: implication for gamete competence.
Laura Di Renzo, Antonino De Lorenzo, Marco Fontanari...
https://pubmed.ncbi.nlm.nih.gov/35353297Perioperative immunonutrition intervention on postoperative outcomes among gynaecological cancer patients under enhanced recovery after surgery setting.
Chiou Yi Ho, Zulfitri Azuan Mat Daud, Barakatun Nisak Mohd Yusof...
https://pubmed.ncbi.nlm.nih.gov/41842985Perioperative immunonutrition intervention on postoperative outcomes among gynecological cancer patients under enhanced recovery after surgery setting: A study protocol of explanatory mixed method study.
ChiouYi Ho, Zulfitri Azuan Mat Daud, Barakatun Nisak Mohd Yusof...
https://pubmed.ncbi.nlm.nih.gov/39739975