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NCT Number: NCT06890221

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

Location status: Recruiting

Location contact

Wai Yin Soo, MD

CONTACT

[email protected]

+60 16-3658711

Wai Yin Soo, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-Crobes intake complete nutrition

Dietary Supplement

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

Other names: Oral nutrition supplement

Placebo

Dietary Supplement

Contains full cream dairy milk

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wai Yin Soo, MD

CONTACT

[email protected]

+60 16-365 8711

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • B-Crobes Laboratory (M) Sdn Bhd

Registry information

Official study title

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

Acronym: IPENIPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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