Recruiting

Radiation Therapy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06729814

Conditions

Breast Cancer

Radiation Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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 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).

Conditions

Breast Cancer

Radiation Dermatitis

Study ID

NCT06729814

Start date

Aug 7, 2024

Status verified date

Aug, 2024

Completion date

Aug 7, 2026

Anticipated

Primary completion date

Aug 7, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Effects of hypofractionated reRT (40Gy in 15 fractions) on acute skin toxicity [ Time Frame: 3 month f/u ]

Central Contacts and Locations

Locations

Odette Cancer Center Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 11, 2024

Last verified

Aug, 2024

Keywords

  • Prospective
  • acute skin toxicities
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-12-11.