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| ID | Type | Description | Link |
|---|---|---|---|
| MECID 2024521-13747 | Other Identifier | Universiti Malaya | |
| NMRR ID-24-01805-DNE | Other Identifier | National Medical Research Register (Malaysia) |
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| Name | Class |
|---|---|
| B-Crobes Laboratory (M) Sdn Bhd | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Placebo Comparator | Placebo |
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| Cohort B | Active Comparator | Oral nutrition supplement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-Crobes intake complete nutrition | Dietary Supplement | Contains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in handgrip strength | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wai Yin Soo, MD | Contact | +60 16-365 8711 | waiyin@ummc.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Malaya Medical Centre | Recruiting | Petaling Jaya | Kuala Lumpur | 50603 | Malaysia |
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Double blinded
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| Placebo | Dietary Supplement | Contains full cream dairy milk |
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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 | 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 | To identify the cutoff value of PA in relation to GLIM malnutrition, nutrition risk, and sarcopenia | From enrollment to 30 days post operation |