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

University of Malaya

Status: Enrolling

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: B-Crobes intake complete nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06890221

IPENIPA

NMRR ID-24-01805-DNE (Other Identifier)

MECID 2024521-13747 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 114 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

114 participants in 2 patient groups, including a placebo group

Cohort A

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

Cohort B

Active Comparator group

Description:

Oral nutrition supplement

Treatment:

Dietary Supplement: B-Crobes intake complete nutrition