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Recruiting NCT06890221

NCT06890221 Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients

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Clinical Trial Summary
NCT ID NCT06890221
Status Recruiting
Phase
Sponsor University of Malaya
Condition Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Study Type INTERVENTIONAL
Enrollment 114 participants
Start Date 2025-03-07
Primary Completion 2026-10-31

Trial Parameters

Condition Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Sponsor University of Malaya
Study Type INTERVENTIONAL
Phase N/A
Enrollment 114
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-03-07
Completion 2026-10-31
Interventions
B-Crobes intake complete nutritionPlacebo

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Brief Summary

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

Inclusion Criteria: * Female * Histopathologically confirmed operable breast cancer * Aged 18 of years and above * Consented and scheduled for mastectomy Exclusion Criteria: * On enteral supplementation prior to the study * Lactose intolerance * Pregnant or lactating * Previous history of gastrectomy or small bowel resection surgery * Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications

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