Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Malaya
About this trial
The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:
1\. Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?
Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.
Participants will:
1. Be randomized into either arm 2. Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively 3. Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Histopathologically confirmed operable breast cancer
Aged 18 of years and above
Consented and scheduled for mastectomy
Disqualifiers
On enteral supplementation prior to the study
Lactose intolerance
Pregnant or lactating
Previous history of gastrectomy or small bowel resection surgery
Trial design
Design model
Parallel
Treatments tested in this trial
B-Crobes intake complete nutrition
Dietary supplementContains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins.
Placebo
Dietary supplementContains full cream dairy milk
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Cohort APlacebo comparator 1 intervention
Group B: Cohort BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean difference of phase angle after nutritional intervention
To measure the mean difference of phase angle between groups after nutritional intervention
Time frame
From enrollment to 30 days post operationSecondary outcomes
1
Changes in handgrip strength
To study the changes on handgrip strength, body composition by bioimpedance analysis (skeletal muscle mass, skeletal muscle mass index, fat free mass and fat mass) after nutritional interventions.
Time frame
From enrollment to 30 days post operation2
Correlation of phase angle with bioimpedance analysis parameters
To describe the correlation of phase angle with nutritional status, handgrip strength, and body compositions by bioimpedance analysis (Skeletal muscle mass, skeletal muscle mass index, fat free mass, and fat mass).
Time frame
From enrollment to 30 days post operation3
Potential factors associated with postoperative complications
To identify the potential factors associated with complications and readmission in 30-days post-mastectomy participants.
Time frame
From enrollment to 30 days post operation4
Cutoff value of phase angle
To identify the cutoff value of PA in relation to GLIM malnutrition, nutrition risk, and sarcopenia
Time frame
From enrollment to 30 days post operationLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Universiti Malaya Medical CentreRecruiting50603, Petaling Jaya, Kuala Lumpur
Malaysia
MalaysiaSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Malaya
Lead sponsor
B-Crobes Laboratory (M) Sdn Bhd
Collaborator
Source ClinicalTrials.gov