Nutrition intervention's effect on breast cancer patients' bioimpedance phase angle
Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients: A Double-Blinded Randomized Controlled Trial
NA · University of Malaya · NCT06890221
This study is testing if giving special nutritional supplements to women with early-stage breast cancer before and after surgery can help them recover better and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Malaya (other) |
| Locations | 1 site (Petaling Jaya, Kuala Lumpur) |
| Trial ID | NCT06890221 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of perioperative nutritional interventions on the bioimpedance phase angle in patients with early-stage breast cancer undergoing mastectomy. Participants will be randomly assigned to receive either an oral nutritional supplement or a placebo for a period of 7 days before surgery and 30 days after. The study will measure various parameters, including phase angle, handgrip strength, and other bioimpedance metrics, to determine the effectiveness of the nutritional intervention in improving surgical outcomes. The goal is to assess whether improved nutrition can lead to better recovery and health metrics post-surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and above with operable early-stage breast cancer scheduled for mastectomy.
Not a fit: Patients with advanced breast cancer, those on enteral supplementation, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance recovery and overall health outcomes for breast cancer patients undergoing surgery.
How similar studies have performed: While this specific approach is novel, similar studies have shown that nutritional interventions can positively impact recovery in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Petaling Jaya, Kuala Lumpur
- Universiti Malaya Medical Centre — Petaling Jaya, Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Study coordinator: Wai Yin Soo, MD
- Email: waiyin@ummc.edu.my
- Phone: +60 16-365 8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Early Stage Breast Cancer, Mastectomy Patient, bioimpedance phase angle, nutritional intervention, oral nutritional supplement