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

NCT06890221 | Recruiting

• 3 other identifiers: IPENIPAMECID 2024521-13747NMRR ID-24-01805-DNE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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. 1.Be randomized into either arm
2. 2.Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
3. 3.Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative

Conditions

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

Keywords

bioimpedance phase angle; nutritional intervention; oral nutritional supplement

Outcome Measures

Primary Outcomes (1)

• Mean difference of phase angle after nutritional intervention

  To measure the mean difference of phase angle between groups after nutritional intervention

  From enrollment to 30 days post operation

Secondary Outcomes (4)

• Changes in handgrip strength

  From enrollment to 30 days post operation

• Correlation of phase angle with bioimpedance analysis parameters

  From enrollment to 30 days post operation

• Potential factors associated with postoperative complications

  From enrollment to 30 days post operation

• Cutoff value of phase angle

  From enrollment to 30 days post operation

Study Arms (2)

Cohort A

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Cohort B

ACTIVE COMPARATOR

Oral nutrition supplement

Dietary Supplement: B-Crobes intake complete nutrition

Interventions

B-Crobes intake complete nutrition DIETARY_SUPPLEMENT

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

Also known as: Oral nutrition supplement

Cohort B

Placebo DIETARY_SUPPLEMENT

Contains full cream dairy milk

Cohort A

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Histopathologically confirmed operable breast cancer
• Aged 18 of years and above
• Consented and scheduled for mastectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• B-Crobes Laboratory (M) Sdn Bhd: collaborator

Study Sites (1)

Universiti Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

RECRUITING

Central Study Contacts

Wai Yin Soo, MD

CONTACT

+60 16-365 8711; waiyin@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Double blinded

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

MY (1)