Odette Cancer Center Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Location status: Recruiting
Location contact
Edward LW Chow, MBBS
CONTACT
Irene Karam, MDCM
CONTACT
NCT Number: NCT06729814
The most common cancer affecting Canadian women is breast cancer, with an estimated 1 in 8 women expected to be diagnosed with breast cancer during their lifetime. Improved screening and treatment have decreased mortality of breast cancer patients, however 14% of cancer-related deaths in Canadian women are still due to breast cancer. Common treatments for breast cancer include surgery, chemotherapy, hormone therapy, and radiation therapy (RT).
Despite recent improvements in treatment and preventative screenings, 20% of breast cancer patients will develop local disease recurrence or another ipsilateral primary breast cancer. . The optimal treatment of recurrent or new primary breast cancers for patients who have undergone prior radiotherapy (RT) is not well-defined. Common treatment approaches consist of mastectomy or a second breast conserving surgery (BCS) with whole or partial breast reirradiation (reRT). In the past, mastectomy has been the preferred treatment for recurrent breast cancer due to concerns over serious acute and late skin toxicities that may result from additional reRT. Many of these late skin toxicities, such as fibrosis, are chronic and can result in patients experiencing pain or other negative impacts to quality of life (QOL).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Toronto, Ontario, M4N 3M5, Canada
Location status: Recruiting
Edward LW Chow, MBBS
CONTACT
Irene Karam, MDCM
CONTACT
Despite recent improvements in treatment and preventative screenings, 20% of breast cancer patients will develop local disease recurrence or another ipsilateral primary breast cancer. The optimal treatment of recurrent or new primary breast cancers for patients who have undergone prior radiotherapy (RT) is not well-defined. Common treatment approaches consist of mastectomy or a second breast conserving surgery (BCS) with whole or partial breast reirradiation (reRT). In the past, mastectomy has been the preferred treatment for recurrent breast cancer due to concerns over serious acute and late skin toxicities that may result from additional reRT. Many of these late skin toxicities, such as fibrosis, are chronic and can result in patients experiencing pain or other negative impacts to quality of life (QOL).
Currently at our centre, the regimen for recurrent breast cancer has been whole or partial (preferred) breast irradiation with a dose fractionation of 45 Gy in 25 fractions. However, there is concern over the treatment burden and skin toxicities that this 5-week long fractionation schedule may cause. Our breast radiation group has been recently allowed to employ 40 Gy in 15 fractions as an acceptable reRT dose fractionation. Therefore, it is vital to investigate dose fractionations for breast cancer patients undergoing retreatment due to being at a high risk of developing severe RD
Furthermore, few previous studies examining breast reRT at any dose for recurrent breast cancer have collected data on patient- and clinician- reported outcomes for QOL and symptoms associated with RD. Therefore, there is a need to conduct further research on the use of hypofractionated reRT for patients with recurrent breast cancer to discover its impact on the severity of acute skin toxicities.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 month f/u
To examine the effects that hypofractionated reRT (40Gy in 15 fractions) has on acute skin toxicity in patients with recurrent ipsilateral breast cancer.
Time frame: 3 month f/u
To evaluate the development of acute skin toxicities and the impact on quality of life due to adverse events caused by using hypofractionated reRT by using the Skindex-16 assessment tool.
Time frame: 3 month f/u
To evaluate the development of acute skin toxicities and the impact on quality of life due to adverse events caused by using hypofractionated reRT by using the RISRAS assessment tool.
Contact information is provided by the study sponsor or research team.
Edward Chow, MBBS
CONTACT
Irene Karam, MDCM
CONTACT
Sunnybrook Health Sciences Centre
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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