Breast CancerNCT06729814
Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fractions Radiation Therapy
An observational study of Breast Cancer and Radiation Dermatitis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2024to 7 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent ipsilateral breast cancer who satisfy the eligibility criteria will be approached for the study.
Who may be able to join
- Age ≥ 18 years old
- Informed consent
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes
- Previous history of ipsilateral breast cancer treated with RT
- Patients are planned to receive hypofractionated (40Gy/15) RT to the whole or partial breast or chest wall
- Patients treated with or without the addition of a planned boost or bolus
- Patients receiving local or locoregional radiation treatment
- Can communicate in English or be aided by a translator
Who cannot join
- Patients scheduled to receive conventionally fractionated (50Gy/25 or 45Gy/25) or extreme hypofractionation (26Gy/5)
- Patients planned to receive brachytherapy
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion
- Concomitant cytotoxic chemotherapy
- Scleroderma
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Odette Cancer Center Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Irene Karam, MDCM, 416-480-4974, Irene.karam@sunnybrook.ca
Edward LW Chow, MBBS, 416-480-4974, Edward.chow@sunnybrook.ca
About this study
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).
Read the detailed description
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.
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- Prospective, acute skin toxicities, Quality of Life
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of hypofractionated reRT (40Gy in 15 fractions) on acute skin toxicity
To examine the effects that hypofractionated reRT (40Gy in 15 fractions) has on acute skin toxicity in patients with recurrent ipsilateral breast cancer.
Measured: 3 month f/u
Secondary outcomes (2)
Impact of QOL due to hypofractionated reRT for breast cancer measured via Skindex 16
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.
Measured: 3 month f/u
Impact of QOL due to hypofractionated reRT for breast cancer measured via RISRAS
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.
Measured: 3 month f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start7 Aug 2024
- Primary completion7 Aug 2025 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Irene Karam, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729814
- Sponsor's protocol ID
- Prospective Study
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fractions Radiation Therapy
- ClinicalTrials.gov ID
- NCT06729814
- Acronym / sponsor ID
- Prospective Study
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- Prospective, acute skin toxicities, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 7 Aug 2025 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent ipsilateral breast cancer who satisfy the eligibility criteria will be approached for the study.
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- Informed consent
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes
- Previous history of ipsilateral breast cancer treated with RT
- Patients are planned to receive hypofractionated (40Gy/15) RT to the whole or partial breast or chest wall
Key exclusion criteria (5 listed)
- Patients scheduled to receive conventionally fractionated (50Gy/25 or 45Gy/25) or extreme hypofractionation (26Gy/5)
- Patients planned to receive brachytherapy
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion
- Concomitant cytotoxic chemotherapy
- Scleroderma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of hypofractionated reRT (40Gy in 15 fractions) on acute skin toxicity
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.
2 secondary outcomes
Impact of QOL due to hypofractionated reRT for breast cancer measured via Skindex 16
Time frame: 3 month f/u
Impact of QOL due to hypofractionated reRT for breast cancer measured via RISRAS
Time frame: 3 month f/u
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Dermatitis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Karam, MDCM (416-480-4974, Irene.karam@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of hypofractionated reRT (40Gy in 15 fractions) on acute skin toxicity (time frame: 3 month f/u). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.