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

NCT06729814 | Recruiting

• 1 other identifier: Prospective Study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Prospective; acute skin toxicities; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  3 month f/u

Secondary Outcomes (2)

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

  3 month f/u

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

  3 month f/u

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent ipsilateral breast cancer who satisfy the eligibility criteria will be approached for the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Center Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Irene Karam, MDCM

CONTACT

416-480-4974; Irene.karam@sunnybrook.ca

Edward Chow, MBBS

CONTACT

416-480-4974; edward.chow@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: December 11, 2024
• Study Start: August 7, 2024
• Primary Completion: August 7, 2025
• Study Completion (Estimated): August 7, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-08

Locations

CA (1)