No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
260 (estimated)
Sponsor
University of Nebraska · Other
Who this trial is looking for
This trial is looking for adults who have breast cancer and are planning to have a specific type of surgery to remove the cancer. Participants will be assigned to receive either a new recovery plan or standard care after their surgery to see which one helps them recover better.
Are You a Good Fit for This Trial?
Must not be takingOpioid pain medications
Rules you outAdvanced breast cancerMetastatic diseaseSubstance use disorder
You may be able to join if
I am 19 years old or older
I can give consent to participate
I have confirmed breast cancer from a biopsy
I have a specific stage of breast cancer
I am undergoing a lumpectomy and sentinel lymph node biopsy
I have not had previous treatment for my breast cancer
I can swallow and retain oral drinks and medications
You may not be able to join if
I am pregnant
I cannot follow the ERAS protocol safely
I am having a different kind of surgery
I have advanced breast cancer or other severe conditions
I have metastatic breast cancer
I am currently taking opioid pain medications for other reasons
I have a history of substance use disorder
I have a condition that could make ERAS unsafe for me
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Males or females 19 years of age or older
* Able to provide study-specific informed consent
* Histologic confirmation of breast cancer on core needle biopsy
* Clinical or radiographic cT1-T3 N0 disease
* Undergoing breast conserving surgery with lumpectomy \& sentinel lymph no…
Inclusion Criteria:
* Males or females 19 years of age or older
* Able to provide study-specific informed consent
* Histologic confirmation of breast cancer on core needle biopsy
* Clinical or radiographic cT1-T3 N0 disease
* Undergoing breast conserving surgery with lumpectomy \& sentinel lymph node biopsy
* No prior definitive treatment or intervention
* Able to swallow and retain oral carbohydrate drinks and medication
Exclusion Criteria:
* Pregnant
* Contraindications to ERAS protocol components
* Undergoing lumpectomy without sentinel lymph node biopsy, mastectomy, or other specified procedures
* Diagnosed with cT4 or N1-3 disease
* Metastatic disease at presentation
* Taking opioid pain medications for other indications
* History of substance use disorder
* Any condition where ERAS could compromise safety
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