ERAS Protocol for Breast Cancer

(ERAS Trial)

Overseen By Rubayat I Khan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Opioid pain medications

Disqualifiers: Pregnant, Metastatic disease, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

260 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking opioid pain medications for other reasons, you cannot participate in the trial.

What data supports the effectiveness of the ERAS Protocol treatment for breast cancer?

The ERAS Protocol, which stands for Enhanced Recovery After Surgery, has been shown to help patients recover faster after surgeries for various conditions, including colorectal cancer and gynecological surgeries. It involves a combination of best practices that reduce stress from surgery and improve recovery times, suggesting it could be beneficial for breast cancer surgery as well. ^{1 2 3 4 5}

Is the ERAS Protocol for Breast Cancer safe for humans?

The safety of anticancer treatments, including those similar to the ERAS Protocol, is often evaluated through specific safety studies. These studies help predict potential adverse events (unwanted side effects) that might occur in patients, ensuring that new treatments are safe for human use. ^{6 7 8 9 10}

How does the ERAS Protocol treatment for breast cancer differ from other treatments?

The ERAS Protocol for breast cancer is unique because it focuses on enhancing recovery after surgery by using a combination of strategies to reduce stress and improve outcomes, unlike traditional treatments that primarily focus on surgery, chemotherapy, or radiotherapy alone. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Juan A Santamaria, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals undergoing breast conserving surgery to remove breast cancer. It's designed to see if a special recovery plan (ERAS) can reduce the need for opioid painkillers and improve post-surgery pain management compared to usual care.

Inclusion Criteria

I am under 19 years old.

Able to provide study-specific informed consent

Histologic confirmation of breast cancer on core needle biopsy

Exclusion Criteria

I am having a lumpectomy, mastectomy, or similar procedure without checking the sentinel lymph node.

My cancer is advanced but has not spread to distant organs.

Any condition where ERAS could compromise safety

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Preparation

Participants receive oral carbohydrate drinks and medications such as acetaminophen and celecoxib as part of the ERAS protocol

1 day

1 visit (in-person)

Surgery and Immediate Recovery

Participants undergo breast conserving surgery and are monitored in the post-anesthesia care unit (PACU) for pain and anti-emetic medication use

1-2 days

Inpatient stay

Follow-up

Participants are monitored for opioid prescriptions and pain levels within 7 days post-surgery

1 week

Treatment Details

Interventions

• ERAS Protocol

Trial Overview The study compares two approaches: ERAS, which involves pre-surgery medications and drinks aimed at easing pain and aiding recovery, versus standard perioperative care. Participants are randomly placed in one of these two groups to measure differences in opioid use and pain levels after surgery.

Participant Groups

Group I: Standard Care Arm Experimental Treatment 1 Intervention

Participants will receive standard peri-operative care without the Enhanced Recovery After Surgery (ERAS) protocol. This includes routine preoperative instructions and omission of the ERAS-specific interventions (oral carbohydrate drink, Celecoxib, and preoperative Acetaminophen). Perioperative medications such as Acetaminophen, Scopolamine, Dexamethasone, and Ondansetron may be given as needed at the discretion of the surgery and anesthesia teams.

Group II: ERAS Protocol Arm Active Control 1 Intervention

Participants will receive the Enhanced Recovery After Surgery (ERAS) protocol as part of peri-operative care. The ERAS protocol includes: (day before surgery) oral carbohydrate drink in the evening, Acetaminophen 1000mg in the evening, Celecoxib 200mg in the morning and evening and (morning of surgery) oral carbohydrate drink 2-4 hours before surgery, Celecoxib 200mg, Acetaminophen 1000mg. Additionally, peri-operative medications such as Acetaminophen, Scopolamine, Dexamethasone, and Ondansetron may be given as needed at the discretion of the surgery and anesthesia teams.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

The ERAS protocol aims to enhance recovery after colorectal cancer surgery and is being tested in a large multicenter trial involving 2200 patients across 28 surgical centers in Piemonte, Italy, to assess its impact on hospital stay length and postoperative outcomes.

The study will compare standard care with the ERAS protocol, monitoring adherence and outcomes like recovery time and patient satisfaction, with a high statistical power of 98% to detect meaningful changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project. Pagano, E., Pellegrino, L., Rinaldi, F., et al.[2021]

The ERAS protocol implemented in gynecological surgery showed no significant difference in length of stay (LOS) between patients undergoing hysterectomy for malignant (2 days) versus benign (2 days) conditions, indicating its effectiveness for both groups.

Patients with malignant and benign conditions had similar rates of complications, reoperations, and readmissions, suggesting that the ERAS protocol is safe and beneficial for enhancing recovery regardless of the nature of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Wijk, L., Franzén, K., Ljungqvist, O., et al.[2018]

In a study of 224 hospitalized oncology patients in Switzerland, 42% experienced at least one adverse event (AE) related to care, with pain and constipation being the most common issues identified.

Among the AEs, 61% were deemed not preventable, highlighting the need for improved safety measures in oncology care to reduce the occurrence of these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Describing adverse events in Swiss hospitalized oncology patients using the Global Trigger Tool. Gerber, A., Da Silva Lopes, A., Szüts, N., et al.[2022]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

In a study of 457 breast cancer patients treated with a combination of neoadjuvant chemotherapy, hormonotherapy, and radiotherapy, 91% of patients in the first protocol and 94% in the second protocol experienced significant tumor regression, with 30% and 40% achieving complete clinical remission, respectively.

The treatment resulted in a high 5-year breast preservation rate of 94% and a local relapse rate of 15%, with disease-free and overall survival rates that are favorable compared to existing literature, indicating the effectiveness of this combined treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary chemotherapy in the treatment of breast cancer]. Auclerc, G., Borel, C., Khayat, D., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

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3. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. [2018]

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Enhanced Recovery After Surgery (ERAS) for Cranial Tumor Resection: A Review. [2022]

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Describing adverse events in Swiss hospitalized oncology patients using the Global Trigger Tool. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. [2022]

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