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

Not Applicable

Recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); Mastectomy Patient

• Registration Number: NCT06890221
• Lead Sponsor: University of Malaya

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-07
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean difference of phase angle after nutritional intervention	From enrollment to 30 days post operation	To measure the mean difference of phase angle between groups after nutritional intervention

Secondary Outcome Measures

Name	Time	Method
Changes in handgrip strength	From enrollment to 30 days post operation	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.
Correlation of phase angle with bioimpedance analysis parameters	From enrollment to 30 days post operation	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).
Potential factors associated with postoperative complications	From enrollment to 30 days post operation	To identify the potential factors associated with complications and readmission in 30-days post-mastectomy participants.
Cutoff value of phase angle	From enrollment to 30 days post operation	To identify the cutoff value of PA in relation to GLIM malnutrition, nutrition risk, and sarcopenia

Trial Locations

Locations (1)

Universiti Malaya Medical Centre; 🇲🇾 Petaling Jaya, Kuala Lumpur, Malaysia