Study on Aspirin’s Effect on Recurrence and Survival in Patients with Non-Metastatic Breast, Colon, Rectal, Stomach, Esophageal, and Prostate Cancer

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What is this study about?

This clinical trial is focused on studying the effects of regular use of aspirin on the recurrence and survival of patients who have undergone primary treatment for common non-metastatic solid tumors. The diseases being studied include breast cancer, colon cancer, rectal cancer, stomach cancer, oesophageal cancer, and prostate cancer. The treatment involves taking aspirin in the form of gastro-resistant tablets, which are designed to dissolve in the intestine rather than the stomach, to help prevent irritation. The study will also use a placebo, which is a tablet that looks like the aspirin tablet but does not contain the active ingredient.

The purpose of the study is to determine if taking aspirin regularly after standard cancer treatment can help prevent the cancer from coming back and improve the chances of survival. Participants in the study will be randomly assigned to receive either the aspirin or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the aspirin and who is receiving the placebo. This helps ensure that the results are not influenced by expectations or bias.

Participants will take the study medication for a period of up to 60 months. Throughout the study, participants will be monitored for any side effects and for signs of cancer recurrence. The study will also look at other health outcomes, such as overall survival, adherence to the medication, and any serious health events that may occur. The goal is to gather information that could lead to better treatment strategies for preventing cancer recurrence and improving survival rates in patients with these types of cancers.

1 joining the study

Upon joining the study, participants are randomly assigned to receive either aspirin or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

The study involves taking a daily dose of either 100 mg or 300 mg of aspirin, or a matching placebo, in the form of a gastro-resistant tablet. The tablets are taken orally.

2 treatment phase

Participants will continue taking the assigned tablet daily for the duration of the study, which is expected to last until August 2028.

Regular follow-up appointments will be scheduled to monitor health status, adherence to the medication, and any side effects experienced.

3 monitoring and assessments

Throughout the study, participants will undergo various assessments to evaluate overall survival, disease-free survival, and any recurrence of the disease.

Additional assessments may include monitoring for serious side effects such as bleeding, vascular events, and other health conditions like diabetes or cognitive changes.

4 completion of the study

At the end of the study period, participants will have a final assessment to determine the long-term effects of the treatment.

The results will contribute to understanding whether regular aspirin use can prevent disease recurrence and improve survival rates in individuals with non-metastatic solid tumors.

Who Can Join the Study?

Participants must have one of the following types of cancer: breast, colon, rectal, stomach, oesophageal, or prostate cancer.
Participants should have completed standard therapy for their cancer and have no signs of the disease spreading to other parts of the body.
Participants must be able to perform daily activities with little or no assistance, as indicated by a WHO performance status of 0, 1, or 2. This means they are fully active, able to carry out light work, or capable of self-care but unable to work.
Participants must provide written informed consent, which means they agree to participate in the study after being informed about its details.
Participants may be receiving or have received certain treatments like neo-adjuvant (before main treatment) or adjuvant (after main treatment) therapy, which are additional treatments to help prevent cancer from returning.
Participants with breast cancer must have specific characteristics, such as having undergone surgery to remove the tumor and having certain test results, like HER2 and ER status, which are markers found in some breast cancer cells.
Participants with colorectal cancer must have had surgery to remove the cancer with clear margins, meaning no cancer cells are left at the edges of the removed tissue.
Participants with gastro-oesophageal cancer must have had treatment aimed at curing the cancer, such as surgery or a combination of chemotherapy and radiation.
Participants with prostate cancer must have had treatment to remove or target the cancer, such as surgery or radiation, and meet specific criteria based on their cancer’s characteristics.
Participants may be involved in other treatment trials, but this must be agreed upon with the relevant trial teams.

Who Cannot Join the Study?

Patients with metastatic cancer cannot participate. This means the cancer has spread to other parts of the body.
Patients who are unable to take aspirin due to allergies or other medical reasons are excluded. Aspirin is a common medication used to relieve pain and reduce fever or inflammation.
Patients who have not completed their standard therapy for cancer are not eligible. Standard therapy refers to the usual treatment given for a particular type of cancer.
Patients with other serious health conditions that might interfere with the study are not allowed to join. This includes conditions that could make it unsafe for them to take part.
Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
Patients who are participating in another clinical trial at the same time are excluded to avoid interference with the study results.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
University Hospital Limerick	Limerick	Ireland
Bon Secours Hospital Cork	Cork	Ireland
University Hospital Waterford	Waterford	Ireland
St Vincent’s University Hospital	Dublin	Ireland
Beaumont Hospital	Dublin	Ireland
Saint Luke’s Radiation Oncology Network	Dublin	Ireland
Cfvh Uuweqzmvpl Hdlbymvv	Cork	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	04.09.2018

Trial locations

Investigated drugs:

Acetylsalicylic Acid

Aspirin is being studied in this trial to see if taking it regularly after standard cancer treatment can help prevent the cancer from coming back and improve survival in patients with common types of non-metastatic solid tumors.

Investigated diseases:

Breast Cancer – A disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules and can spread to other parts of the body. The progression can vary, with some tumors growing slowly and others more rapidly. Hormonal, genetic, and environmental factors can influence its development. Symptoms may include changes in breast shape, lumps, or skin changes.

Colon Cancer – This cancer starts in the colon or large intestine, often beginning as small, benign clumps of cells called polyps. Over time, some polyps can become cancerous. It may cause changes in bowel habits, blood in the stool, or abdominal discomfort. The disease can spread to other parts of the body if not detected early. Risk factors include age, diet, and family history.

Rectal Cancer – Similar to colon cancer, this type begins in the rectum, the last several inches of the large intestine. It often starts as a polyp that can become cancerous over time. Symptoms may include rectal bleeding, changes in bowel habits, and discomfort. The disease can progress to affect nearby organs and tissues. Lifestyle factors and genetics can play a role in its development.

Stomach Cancer – Also known as gastric cancer, it begins in the stomach lining and can grow to invade other parts of the stomach and nearby organs. Symptoms might include indigestion, stomach pain, nausea, and weight loss. The progression can be slow, with symptoms often appearing in advanced stages. Risk factors include diet, smoking, and certain infections.

Oesophageal Cancer – This cancer occurs in the esophagus, the tube that carries food from the throat to the stomach. It can start in the cells lining the esophagus and may cause difficulty swallowing, chest pain, or weight loss. The disease can spread to nearby tissues and organs. Risk factors include smoking, alcohol use, and certain medical conditions.

Prostate Cancer – A common cancer in men, it begins in the prostate gland, which produces seminal fluid. It often grows slowly and may not cause symptoms initially. As it progresses, it can lead to urinary difficulties, pelvic pain, or erectile dysfunction. The disease can spread to bones and other organs if not managed. Age, family history, and race are significant risk factors.

Trial ID:

2024-511306-23-00

Protocol code:

AA01

NCT ID:

NCT02804815

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Aspirin’s Effect on Recurrence and Survival in Patients with Non-Metastatic Breast, Colon, Rectal, Stomach, Esophageal, and Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?