Health TrialsbyHealthPanel

Perioperative Immunonutrition Under Enhanced Recovery After Surgery

ConditionsGynecological CancerElective Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorUniversiti Putra Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those who diagnosed with GC

Candidates for elective operation treatments

Disqualifiers

Those are involved gastrointestinal tract (complication)

Those are diagnosed with GC (metastasis)

Allergy to milk/soy/whey protein

Participate in other intervention study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunonutrition oral nutrition supplementation

    Dietary supplement

    Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: conventionalNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

daily energy and protein intake

24-hours diet recall

Time frame
1 month
2

body composition

body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter

Time frame
1 month
3

immunoglobulin level

Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M

Time frame
1 month
4

C-reactive protein

Concentration of C-reactive protein

Time frame
1 month

Secondary outcomes

1

Functional status

handgrip strength in kg via Jammar dynamometer

Time frame
1 month
2

stress level

questionnaire 10-item perceived stress scale (PSS-10) form

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Putra Malaysia

Lead sponsor

Source ClinicalTrials.gov
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