RECRUITING

ERAS Protocols in Breast Conserving Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Enhanced Recovery After Surgery (ERAS) protocols have been of increasing interest in the surgical community for decades. The emphasis has been development of protocols to maximize pain control post-operatively without the use of opioids. While this approach has been studied extensively in the oncology surgery literature, little data exists on the utility of ERAS protocols in the setting of breast conserving surgery (BCS), which is a type of surgery to remove breast cancer while saving as much of the breast as possible. The purpose of this study is to determine the utility of implementing ERAS protocols in breast cancer patients undergoing breast conserving surgery. Study participants will be randomized to either ERAS protocol or standard peri-operative care without ERAS. The study will assess the how many opioid prescriptions are given in the first week after surgery and how much pain participants report right after surgery. Investigators will also look at how long participants stay in the recovery room and if medicine for nausea is needed.

Official Title

The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial

Quick Facts

Study Start:2025-07-11
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06938581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females 19 years of age or older
  2. * Able to provide study-specific informed consent
  3. * Histologic confirmation of breast cancer on core needle biopsy
  4. * Clinical or radiographic cT1-T3 N0 disease
  5. * Undergoing breast conserving surgery with lumpectomy \& sentinel lymph node biopsy
  6. * No prior definitive treatment or intervention
  7. * Able to swallow and retain oral carbohydrate drinks and medication
  1. * Pregnant
  2. * Contraindications to ERAS protocol components
  3. * Undergoing lumpectomy without sentinel lymph node biopsy, mastectomy, or other specified procedures
  4. * Diagnosed with cT4 or N1-3 disease
  5. * Metastatic disease at presentation
  6. * Taking opioid pain medications for other indications
  7. * History of substance use disorder
  8. * Any condition where ERAS could compromise safety

Contacts and Locations

Study Contact

Juan A Santamaria, MD
CONTACT
402-559-7272
juan.santamaria@unmc.edu
Rubayat I Khan, PhD
CONTACT
402-559-2983
rubayat.khan@unmc.edu

Principal Investigator

Juan A Santamaria, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Juan A Santamaria, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11
Study Completion Date2029-02

Study Record Updates

Study Start Date2025-07-11
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Eras
  • Opioid Use
  • Pain Management
  • Breast Conserving Surgery
  • Sentinel Lymph Node Biopsy
  • Perioperative Care

Additional Relevant MeSH Terms

  • Breast Cancer
  • Postoperative Recovery