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NCT Number: NCT06729814

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Impact of QOL due to hypofractionated reRT for breast cancer measured via Skindex 16

    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.

  2. Impact of QOL due to hypofractionated reRT for breast cancer measured via RISRAS

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edward Chow, MBBS

CONTACT

[email protected]

416-480-4974

Irene Karam, MDCM

CONTACT

[email protected]

416-480-4974

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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