RecruitingOBSERVATIONAL

Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fractions Radiation Therapy

This study is for women who have had breast cancer treatment with radiation before, and whose cancer has either come back or they've developed a new breast cancer. When breast cancer returns, doctors often consider a mastectomy or further surgery along with more radiation therapy. However, repeat radiation can sometimes cause skin problems, like redness or pain. This study is testing a shorter course of repeat radiation, given over three weeks instead of five. The main goal is to see if this new, shorter treatment causes fewer or less severe skin problems and helps improve patients' overall quality of life. By finding better ways to deliver repeat radiation, doctors hope to offer effective treatment with fewer side effects.

At a glance

Status

Recruiting

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

07 Aug 2024

Estimated completion

07 Aug 2026

Breast Cancer Radiation Dermatitis

What is this study about?

Breast cancer is a common illness that affects many women. While screening and treatments have really improved over the years, sometimes breast cancer can come back in the same breast or a new cancer can develop. If this happens, doctors need to decide on the best way to treat it, especially if you've already had radiation therapy in that area.

Historically, to avoid potential skin reactions from more radiation, some doctors chose to remove the breast (mastectomy). However, other options include further surgery to remove the cancer, combined with more radiation treatment. One concern with this repeat radiation is that it can sometimes lead to skin issues, both straight away and later on. These problems can include redness, soreness, and long-term changes to the skin like hardening, which can sometimes be painful and affect how you feel day-to-day.

This study is looking into a slightly different way of giving this second course of radiation. Instead of the usual five-week treatment, they are trying a shorter, three-week schedule. The main aim is to see if this shorter treatment is just as effective at treating the cancer but causes fewer or less severe skin side effects. Researchers will be carefully checking how patients' skin reacts and will also ask about their overall well-being and any symptoms they might experience. This research is important because it could help improve treatment options and reduce side effects for women who need repeat radiation for breast cancer, ultimately enhancing their quality of life.

Key takeaways

This study is for women who need repeat radiation for breast cancer.
It tests a shorter, three-week radiation treatment to see if it reduces skin side effects.
Researchers will monitor skin reactions and ask about patients' comfort and well-being.
The aim is to find better ways to treat recurrent breast cancer with fewer side effects.
Improvements in treatment could mean a better quality of life for patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to give your informed consent. You must have been diagnosed with breast cancer that has been confirmed by a doctor, and you should have already received radiation therapy to that breast in the past. The study is specifically for patients who are planned to receive a new, shorter course of radiation therapy, delivered as 40 Gy in 15 sessions (which is about three weeks of treatment) to part or all of your breast or chest wall. You can also be taking part if you're receiving additional boosts or bolus treatments, and you must be able to communicate in English or have help from a translator.

However, you cannot join the study if you are scheduled to receive other types of radiation therapy, such as the standard five-week course, very short (one-week) radiation, or internal radiation (brachytherapy). You also can't participate if you have an active rash or existing skin problems in the treatment area that might make it hard to check your skin for the study. Additionally, if you are currently having certain types of chemotherapy or have a condition called scleroderma, you will not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you previously had radiation therapy for breast cancer?
Are you scheduled to have a new course of radiation therapy over about three weeks (40 Gy in 15 sessions)?
Do you not have an active rash or other skin condition in the treatment area that would make monitoring difficult?
Are you currently not receiving specific types of chemotherapy or diagnosed with scleroderma?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be receiving a specific type of radiation therapy for your breast cancer. During your treatment, doctors and nurses will closely monitor your skin for any reactions or side effects. They will likely ask you questions about how you are feeling and any symptoms you might have. You may need to fill out questionnaires about your quality of life. The total duration of your active treatment will be around three weeks, and there will be follow-up assessments to see how your skin heals and how you are doing in the weeks and months after treatment. The exact number of visits for assessment after your radiation will be explained to you by the study team.

Potential risks and benefits

Taking part in this study may offer the potential benefit of receiving a new, potentially less intense radiation treatment that could lead to fewer skin side effects, though this is what the study aims to find out. There are also potential risks involved, mainly related to the radiation therapy itself, such as skin redness, soreness, or long-term changes to the skin. The study will carefully monitor these effects. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Odette Cancer Center Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 're-irradiation'?

It means having radiation therapy again in an area that has already been treated with radiation in the past.

What are 'skin toxicities'?

This refers to side effects that affect the skin, like redness, soreness, dryness, or peeling, that can happen during or after radiation treatment.

Why is a shorter radiation schedule being tested?

Doctors want to see if giving radiation in fewer, slightly stronger doses over a shorter time (like three weeks instead of five) can be just as effective while causing fewer skin problems.

Will taking part affect my regular cancer care?

No, your participation is voluntary and you can leave the study at any time, and this will not affect the quality of your regular medical care.

What does 'quality of life' mean in this study?

This means how your daily life is affected by your health and treatment – for example, your comfort, pain levels, and general well-being.

How to find out more

Irene Karam, MDCM

irene.karam@sunnybrook.ca 416-480-4974 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.