Breast Cancer Early Stage Breast Cancer (Stage 1-3), Mastectomy Patient
Conditions
Keywords
bioimpedance phase angle, nutritional intervention, oral nutritional supplement
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
Interventions
DIETARY_SUPPLEMENTB-Crobes intake complete nutrition
Contains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins.
DIETARY_SUPPLEMENTPlacebo
Contains full cream dairy milk
Sponsors
B-Crobes Laboratory (M) Sdn Bhd
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Double blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Malaysia
Contacts
Primary ContactWai Yin Soo, MD
Outcome results
None listed