Gabapentin for Breast Cancer Surgery

Recruiting at 6 trial locations

Overseen By Andrew Vickers, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Peri-operative period

1896 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether gabapentin, a medicine typically used to treat nerve pain, should become a regular part of pain management for patients undergoing breast removal surgery (mastectomy). The study compares usual pain control methods with and without gabapentin to determine its impact on recovery. Individuals scheduled for a mastectomy at the Josie Robertson Surgical Center who meet the criteria may qualify for this study. As a Phase 4 trial, this research aims to understand how gabapentin, an FDA-approved and effective treatment, can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for gabapentin?

Research shows that gabapentin is generally safe for people, but it can have some side effects. Studies have found that gabapentin can help reduce pain and lessen the need for opioids after surgery. However, it might also cause some unwanted effects. For example, one study noted a slight increase in confusion and the need for new antipsychotic medications in patients taking gabapentin during surgery. While the FDA has approved gabapentin for treating nerve pain and seizures, these findings emphasize the need to monitor its effects when used for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Gabapentin is unique because it offers a different approach to managing pain associated with breast cancer surgery. Unlike the standard pain management options, which typically include opioids and NSAIDs, gabapentin targets nerve-related pain by modulating neurotransmitter release in the nervous system. Researchers are excited about gabapentin because it could potentially reduce the reliance on opioids, which are known for their side effects and addiction risks. This could lead to better pain management with fewer complications for patients post-surgery.

What is the effectiveness track record for gabapentin in peri-operative pain control for mastectomy patients?

Research has shown that gabapentin can reduce pain for people undergoing breast cancer surgery. Studies have found that gabapentin lowers both short-term and long-term pain after these surgeries. One study showed that patients taking gabapentin used 50% less opioids (strong painkillers) from days 2 to 10 after surgery compared to those who didn't take it. Gabapentin also provided better pain relief than other methods, such as the stellate ganglion block, another pain management technique. In this trial, participants in the intervention arm will have gabapentin removed from their pre-operative order set, while the control arm will follow the standard of care. These findings suggest that gabapentin could be a helpful part of pain management plans for breast cancer surgery patients. ^{1 2 3 5 6}

Who Is on the Research Team?

James Flory, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

The GABS-DART study is for individuals aged 18 to 65 who are scheduled for a type of breast removal surgery called an ambulatory extended recovery mastectomy at the Josie Robertson Surgical Center. It's not specified who can't join, but typically those with health conditions affecting study participation or medication use would be excluded.

Inclusion Criteria

I am between 18 and 65 years old.

I am scheduled for a mastectomy with extended recovery at JSRC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or a modified pre-operative order set without gabapentin

Peri-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 46 months

What Are the Treatments Tested in This Trial?

Interventions

• Gabapentin

Trial Overview

This trial is testing if adding gabapentin, a pain control medication, to the pre-surgery routine improves patient outcomes after mastectomy surgeries at Memorial Sloan Kettering Cancer Center. The focus is on whether it should become a standard part of care before these operations.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

The study intervention will consist of modification to the pre-operative order set to remove gabapentin.

Group II: Control Arm Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6160249/

The efficacy of gabapentin in reducing pain intensity and ...

Results from current meta-analysis indicated that gabapentin can decrease acute and chronic pain after breast cancer surgery. Results showed ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00982800

Does Postoperative Gabapentin Reduce Pain, Opioid ...

Opioid consumption was reduced by 50% in the Gabapentin and Mexiletine groups vs. the placebo group on days 2-10. Only the Gabapentin group had decreased pain ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1748681517302322

Review Preoperative pregabalin or gabapentin for acute ...

Our findings suggest that gabapentin may reduce acute postoperative pain and opioid consumption within the first 24 h after breast cancer surgery. Pregabalin ...

4.

journals.lww.com

journals.lww.com/plasreconsurg/fulltext/2015/10001/preoperative_pregabalin_or_gabapentin_for.236.aspx

Preoperative Pregabalin or Gabapentin for Postoperative...

There was no effect of gabapentin on chronic mastectomy pain. Pregabalin decreased morphine consumption in recovery compared to placebo (MD= -4.8 mg, 95% CI - ...

5.

dovepress.com

dovepress.com/a-review-on-the-management-of-peripheral-neuropathic-pain-following-br-peer-reviewed-fulltext-article-BCTT

Neuropathic pain management after breast cancer | BCTT

Furthermore, gabapentin was also observed to produce improved pain relief compared to stellate ganglion block (SGB).

6.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2796501

Perioperative Gabapentin Use and In-Hospital Adverse ...

In this cohort study, we found that perioperative gabapentin use was associated with modestly increased risk of delirium, new antipsychotic use, ...