Elective Surgery, Gynecological Cancer
Conditions
Keywords
gynecological cancer, elective surgery
Brief summary
The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are: * is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups? * is there any difference in the post-surgical outcomes between intervention and conventional groups? Participants (intervention) will be provided the immunonutrition supplement before and after operation. Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.
Detailed description
The clinical trial aims to determine the effectiveness of perioperative IMN intervention on postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS) setting. Patients will prescribed with immunonutrition supplement before and after surgery.
Interventions
DIETARY_SUPPLEMENTImmunonutrition oral nutrition supplementation
Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Those who diagnosed with GC 2. Candidates for elective operation treatments
Exclusion criteria
1. Those are involved gastrointestinal tract (complication) 2. Those are diagnosed with GC (metastasis) 3. Allergy to milk/soy/whey protein 4. Participate in other intervention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body composition | 1 month | body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter |
| C-reactive protein | 1 month | Concentration of C-reactive protein |
| postoperative outcomes | 1 months | length of hospitalization |
| daily energy and protein intake | 1 month | 24-hours diet recall |
| immunoglobulin level | 1 month | Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stress level | 1 month | questionnaire 10-item perceived stress scale (PSS-10) form |
| Functional status | 1 month | handgrip strength in kg via Jammar dynamometer |
Countries
Malaysia
Contacts
Primary ContactChiouYi Ho
Backup ContactZulfitri 'Azuan Mat Daud
Outcome results
None listed