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Compares treatment options for Breast Cancer
Official title Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position
ClinicalTrials.gov ID: NCT06915857
What this study is testing
- What it's testing
- Radiotherapy (RT) is common in the treatment of breast cancer, however, 95% of breast cancer patients are at risk of developing acute and chronic skin toxicities known as radiation dermatitis (RD) which includes symptoms such as pruritus, edema, erythema, and moist desquamation (MD). Patients with a larger breast size are especially at risk of developing RD.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years.
- Female.
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes.
- Patients with large breasts [bra size 40 in and/or D cup or greater] and have undergone breast-conserving surgery.
- Patients are scheduled to receive conventionally- (50Gy/25#), hypo-fractionated (40Gy/15#), or extreme hypo-fractionated (26Gy/5#) photon-based...
You likely can't join if
- Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation.
- Prior RT to any portion of the planned treatment site.
- Active rash or pre-existing dermatitis within the treatment field.
- Concomitant cytotoxic chemotherapy.
- Unable to tolerate RT in prone.
- Treatment involves use of tissue equivalent bolus.
See the full eligibility criteria
- Age ≥ 18 years.
- Female.
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes.
- Patients with large breasts [bra size 40 in and/or D cup or greater] and have undergone breast-conserving surgery.
- Patients are scheduled to receive conventionally- (50Gy/25#), hypo-fractionated (40Gy/15#), or extreme hypo-fractionated (26Gy/5#) photon-based radiation to whole or partial breast in prone position.
- Patients treated with or without the addition of a boost.
- Patient speaks English or can be aided by a translator.
- Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation.
- Prior RT to any portion of the planned treatment site.
- Active rash or pre-existing dermatitis within the treatment field.
- Concomitant cytotoxic chemotherapy.
- Unable to tolerate RT in prone.
- Treatment involves use of tissue equivalent bolus.
- Known sensitivity or allergy to betamethasone.
- Known pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.