RecruitingNot ApplicableNCT06890221

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

Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients: A Double-Blinded Randomized Controlled Trial

Sponsor

University of Malaya

Enrollment

114 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Mastectomy Patient

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving nutritional support (special protein supplements) around the time of mastectomy (breast removal surgery) improves body composition — specifically maintaining or building muscle — in women with breast cancer. A device called a bioimpedance analyzer tracks muscle and fat changes. **You may be eligible if...** - You are a female patient - You have been confirmed to have operable breast cancer by a biopsy - You are 18 or older - You are scheduled to have a mastectomy **You may NOT be eligible if...** - You are already on nutritional supplements - You have lactose intolerance - You are pregnant or breastfeeding - You have had prior stomach or small bowel surgery - You have advanced (metastatic) breast cancer, a pacemaker, severe liver or kidney disease, uncontrolled diabetes, or are on steroid therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTB-Crobes intake complete nutrition

Contains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins.

DIETARY_SUPPLEMENTPlacebo

Contains full cream dairy milk

Locations(1)

Universiti Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, Malaysia

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NCT06890221

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