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Study on the Effects of Ketorolac and Pregabalin in Patients Undergoing Surgery for Early Estrogen Receptor-Positive Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of surgery and certain medications in patients with estrogen receptor-positive early breast cancer. The medications being studied are ketorolac and pregabalin. Ketorolac is a medication that helps reduce inflammation, while pregabalin is used to block certain neurotransmitters, which are chemicals in the brain that help transmit signals.

The purpose of the study is to understand how these medications, when used around the time of surgery, affect inflammation and neurotransmitter levels in the body. Participants will receive either ketorolac, pregabalin, or a placebo before their surgery. The study will monitor changes in inflammation and neurotransmitter levels in the blood, as well as other factors related to the cancer and the body's response to surgery.

Throughout the study, participants will have their blood tested at various times to measure changes in specific substances. The study will also look at how these medications might affect anxiety and pain levels after surgery. The goal is to gather information that could help improve treatment strategies for breast cancer patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and medical history.
A negative pregnancy test is required for women of childbearing potential.
Consent is obtained for participation and for providing tissue and blood samples for research purposes.
Step 2
Preoperative phase
Before surgery, the use of ketorolac and pregabalin is initiated. These medications are taken orally.
Ketorolac is used to assess its effect on inflammation, while pregabalin is used to evaluate its impact on neurotransmitters.
The exact dosage and frequency of these medications are determined by the study protocol.
Step 3
Surgery
Primary breast cancer surgery is performed as scheduled.
During surgery, samples are collected for further analysis to assess the effects of the medications.
Step 4
Postoperative phase
After surgery, the effects of the medications on inflammation and neurotransmitters are monitored.
Blood samples are taken at various time points to measure changes in specific markers.
Step 5
Follow-up
Follow-up assessments are conducted to monitor recovery and any potential side effects.
The study continues to collect data on the impact of the medications on inflammation and neurotransmitter levels.

Who can join the trial?

15 criteria

Age between 18 and 70 years old.
Willing to provide a sample from a recent biopsy of the tumor for testing.
Willing to take **omeprazole** (a medication that reduces stomach acid) and has no medical reasons preventing its use.
Have a **HEMSTOP score** less than 2 and normal blood clotting test results. This means your blood clots normally.
Women who can have children must agree to use a highly effective birth control method before, during, and for at least one month after the study.
Negative pregnancy test for women who can have children, done within 30 days before starting treatment.
Willing and able to sign a consent form to participate in the trial.
Must be female.
Weigh at least 35 kg (about 77 pounds).
Have a diagnosis of **invasive breast adenocarcinoma** that is **estrogen receptor-positive**. This means the breast cancer cells grow in response to the hormone estrogen.
Tumor size must be at least 1.5 cm, as measured by ultrasound or MRI/CT scan.
Have Stage I, II, or III breast cancer, which means the cancer has not spread to other parts of the body.
If there are multiple tumors in one or both breasts, all must be estrogen receptor-positive.
Scheduled for primary breast cancer surgery.
Willing to provide blood and tumor samples for research purposes.

Who cannot join the trial?

3 criteria

Patients who do not have estrogen receptor-positive early breast cancer cannot participate. This means the cancer must be sensitive to the hormone estrogen.
Only female patients are eligible. Male patients cannot participate.
Patients who are considered part of a vulnerable population are excluded. This typically refers to groups who may have additional risks or need special protection in research.

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Investigated drugs

Ketorolac
is a medication used in this trial to block certain enzymes in the body that cause inflammation. The goal is to see if taking ketorolac before surgery can reduce inflammation in patients with primary breast cancer.
Pregabalin
is another medication used in the trial to block certain neurotransmitters in the nervous system. The aim is to determine if pregabalin, when taken before surgery, can provide benefits by reducing nerve-related symptoms in patients with primary breast cancer.

What is already known about the treatment

Ketorolac
Ketorolac is administered orally or through injection and is currently being studied for its effects in breast cancer surgery. It is primarily used for its anti-inflammatory properties, particularly in managing pain and inflammation. The medication works by blocking the enzyme cyclooxygenase (COX), which is involved in the production of substances that cause inflammation and pain. Ketorolac is classified as a nonsteroidal anti-inflammatory drug (NSAID).
Pregabalin
Pregabalin is taken orally and is being evaluated for its potential benefits in breast cancer surgery. It is mainly used to manage nerve pain and seizures. Pregabalin functions by binding to certain calcium channels in the nervous system, reducing the release of neurotransmitters that can cause pain. It is classified as an anticonvulsant and neuropathic pain agent.

Investigated diseases

Estrogen Receptor-Positive Early Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells. These receptors allow the cancer cells to use estrogen to grow and multiply. In its early stages, the cancer is typically confined to the breast tissue and has not spread to other parts of the body. The progression of the disease can vary, but it often involves the growth of the tumor within the breast. Over time, if not managed, it may spread to nearby lymph nodes or other areas. The presence of estrogen receptors often influences the approach to treatment and management of the disease.