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

March 21, 2025 updated by: Soo Wai Yin, University of Malaya

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Petaling Jaya, Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • Universiti Malaya Medical Centre
        • Contact:
        • Contact:
          • Wai Yin Soo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cohort A
Placebo
Dietary supplement: Placebo
Contains full cream dairy milk
Active Comparator: Cohort B
Oral nutrition supplement
Dietary supplement: B-Crobes intake complete nutrition
Contains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins.
Other Names:
  • Oral nutrition supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of phase angle after nutritional intervention
Time Frame: From enrollment to 30 days post operation
To measure the mean difference of phase angle between groups after nutritional intervention
From enrollment to 30 days post operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

B-Crobes Laboratory (M) Sdn Bhd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPENIPA
  • MECID 2024521-13747 (Other Identifier: Universiti Malaya)
  • NMRR ID-24-01805-DNE (Other Identifier: National Medical Research Register (Malaysia))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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