Protocol No.UW18101
Principal InvestigatorGast, Katherine
PhaseIII
Age GroupAdult
ClinicalTrials.GovNCT03764943 (Click to jump to clinicaltrials.gov)
Management Group(s) Oncology Outside Research Groups (ORG)

Title
Evaluating the Use of Enhanced Recovery Preoperative Immunonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction

Description
Phase III Study of Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

Objective
The purpose of this research study is to determine whether preoperative immunonutrition supplementation (with Impact Advanced Recovery, a nutritional shake) and carbohydrate loading (with Boost Breeze) can reduce the rate of wound complications and the need for additional unplanned surgeries in patients undergoing immediate breast reconstruction. Additionally, we would like to study the impact of these supplements on the length of your hospital stay following surgery if you are undergoing autologous reconstruction

Treatment The patients will be split into two groups:

Subjects undergoing alloplastic reconstruction will be enrolled into group 1 of the study

Subjects undergoing autologous reconstruction will be enrolled into group 2 of the study

All patients will be provided the nutritional supplements (one case of 15, 200mL Impact Advanced Recovery shakes, one 200mL Boost Breeze drink), as well as a"data collection sheet";"consumption diary"; with the dates that they will be drinking the Impact Advanced Recovery and Boost Breeze with boxes to mark each shake they consumed daily

You will be instructed to drink three Impact Advanced Recovery shakes daily (around morning, mid-day and evening) for 5 days prior to their surgical date. They will then be instructed to drink the Boost Breeze on the day of surgery, 2 hours prior to the scheduled surgery time

Key Eligibility
Age equal to and greater than 18 years.

Medically cleared to undergo oncologic resection and breast reconstructive surgery (including associated anesthesia) at the University of Wisconsin Hospital

Undergoing unilateral or bilateral immediate alloplastic or autologous breast reconstruction by Drs. Afifi, Garland, Gast, Michelotti, Poore, Rao or Siebert

EXCLUSION

Pregnant or breast-feeding women.

Incarcerated women

Males

Individuals unable to give consent due to another condition such as impaired decision-making capacity

Women with intolerance or allergy to any ingredients contained within the Impact Advanced Recovery or Boost Breeze formulas that prevents safe consumption of these products

Impact Advanced Recovery and Boost Breeze formulas are both suitable for lactose intolerance, gluten-free, kosher, and halal diets

We will exclude individuals with galactosemia

Women who are unable to take oral nutritional supplements

Applicable Disease Sites
Breast

Participating Institutions
UW Health University Hospital