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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special recovery protocol called ERAS can reduce the need for opioids in people recovering from breast cancer surgery. ERAS, which stands for Enhanced Recovery After Surgery, includes steps like special drinks and medications before and after surgery. The trial compares patients using ERAS with those receiving standard care to assess who reports less pain and requires fewer opioid prescriptions in the first week. It is open to individuals diagnosed with certain stages of breast cancer who are scheduled for breast-conserving surgery, which removes the cancer but preserves most of the breast. Participants must be able to swallow the drinks and pills used in the ERAS protocol. As an unphased trial, this study offers an opportunity to contribute to innovative recovery strategies that could enhance post-surgery experiences for future patients.

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 prior data suggests that the ERAS protocol is safe for breast cancer patients undergoing breast conserving surgery?

Research has shown that Enhanced Recovery After Surgery (ERAS) plans are generally easy for patients to manage. In one study, patients who followed ERAS guidelines spent less time in the hospital and experienced fewer complications. Another study found that ERAS reduced pain and nausea after surgery, leading to a decreased need for painkillers, which indicates improved safety. The ERAS plan typically includes medications such as Acetaminophen (a common pain reliever) and Celecoxib (an anti-inflammatory), which are generally safe when used as directed. Overall, the ERAS approach appears to facilitate faster recovery with fewer issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ERAS protocol for breast cancer surgery because it aims to improve recovery times and reduce complications by enhancing peri-operative care. Unlike standard care, which typically doesn't include pre-surgery carbohydrate drinks or specific medications like Celecoxib, the ERAS protocol introduces these to help optimize the body’s response before and after surgery. This approach could potentially lead to quicker recoveries and less postoperative pain, making the surgical experience smoother for patients. By comparing these two approaches, researchers hope to find out if the ERAS protocol can set a new standard for surgical care in breast cancer treatment.

What evidence suggests that the ERAS protocol is effective for breast cancer surgery?

Studies have shown that Enhanced Recovery After Surgery (ERAS) protocols help patients recover faster and with less pain. For instance, patients often spend less time in the hospital and experience reduced pain with ERAS. In this trial, participants in the ERAS Protocol Arm will receive specific interventions that have also reduced nausea and vomiting after surgeries like breast reconstruction. These benefits make ERAS appealing for breast-conserving surgeries, where the goal is to remove cancer while preserving most of the breast. Overall, research suggests that ERAS can improve recovery experiences through simple methods, such as specific medications and pre-surgery drinks. ^{2 3 4 5 6}

Who Is on the Research Team?

Juan A Santamaria, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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

Able to provide study-specific informed consent

Histologic confirmation of breast cancer on core needle biopsy

I am under 19 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8406354/

Positive effects of the enhanced recovery after surgery ...

After implementing the postoperative ERAS protocol, hospital length of stay decreased from 6 to 5 days, a significant lower average pain score was recorded and ...

2.

abs.amegroups.org

abs.amegroups.org/article/view/8345/html

Enhanced recovery after surgery for breast reconstruction—a ...

Conclusions: The implementation of ERAS protocols in breast reconstruction surgery significantly reduces LOS in patients undergoing autologous reconstructions ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06938581

ERAS Protocols in Breast Conserving Surgery

Improved analgesia and reduced post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) pathway for total mastectomy ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2820097

Enhanced Recovery After Surgery Guidelines and Hospital ...

Conclusions and Relevance In this meta-analysis, ERAS guidelines were associated with decreased hospital length of stay and complications.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2468784723000673

Implementation of enhanced recovery after surgery ...

Our study was conducted to investigate the effects of implementing an ERAS pathway for mastectomies, including the length of hospital stay, postoperative ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38488251/

Enhanced recovery after surgery for oncological breast ...

Results: 104 patients were identified. In the post-ERAS group, 74.4% were discharged within 24 h compared to 23.1% in the pre-ERAS group. Length of stay was ...