Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position

NCT06915857 | Recruiting Phase 3

• 1 other identifier: Betamethasone RCT
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

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. The severity of RD can impact patient's quality of life (QOL) and their ability to complete treatment. Skin care guidelines for patients receiving RT vary and include barrier films and dressings, antibiotics, topical corticosteroids, and moisturizers. A study conducted at the Sunnybrook Odette Cancer Centre investigated the effectiveness of the prone treatment position during RT compared to the supine position. The results indicated that the prone position reduced the incidence of MD from 39.6% in supine to 26.9% in prone. However, 1 in 4 patients in the prone position still develop MD. Another study conducted at Sunnybrook Odette Cancer Centre found that Mepitel Film (MF), a barrier film, is more effective than the standard of care in preventing grade 2 or 3 RD, reducing the incidence of grade 2 or 3 RD from 45% to 15%. Despite its effectiveness, MF cannot be used for patients in the prone position and is costly. The topical corticosteroid betamethasone can prevent skin toxicity through its anti-inflammatory properties and is absorbed by the skin with minimal side effects. Betamethasone is cost-efficient and studies have found that it is effective in reducing the severity of RD in the supine position by half. Moreover, betamethasone can be applied in patients positioned in both prone and supine. The investigators hypothesize that adding betamethasone in large-breasted patients treated in prone during RT will further reduce RD. This randomized control trial is the first of its kind to aim at investigating the effectiveness of betamethasone when compared with the standard of care in reducing the severity of RD in large-breasted patients being treated in the prone position during RT. The investigators will enroll 276 breast cancer patients with band size ≥ 40 or ≥ D cup to be randomized to receive 0.1% betamethasone cream or the standard of care in a 2:1 ratio (alpha = 5% and power = 80% with the hypothesis that the addition of betamethasone to prone reduces the severity of RD from 30% to 15%). Upon enrolment, stratification factors will be recorded, and patients will be randomized into trial arms using procedures that balance stratification factors. All eligible patients will be stratified according to the following factors: patients receiving conventional RT (50Gy/25#) versus hypofractionated RT (40Gy/15#) versus extreme-hypofractionated RT (26Gy/5#), whole or partial breast radiation, patients with Fitzpatrick skin type VI versus patients with Fitzpatrick skin type I-V, patients receiving a planned boost versus patients without planned boost. The CRA will be responsible for collection of assessments and photos from patients. Patients will use the assigned cream daily during RT treatment and up until 2 weeks after RT. The primary endpoint of this study is acute grade 2 or 3 toxicities as defined by the Common Terminology Criteria for Adverse Events v5.0. Secondary endpoints will include patient- and clinician-reported outcomes as assessed by the Skin Symptom Assessment and the Radiation-Induced Skin Reaction Assessment Scale. Moreover, the investigators will also employ a QOL tool, the Skindex-16, and a Patient Satisfaction Questionnaire. Patients will complete assessments weekly during RT and 2 weeks post-RT in person, followed by 6 weekly assessments and a 3-month telephone follow-up post-RT. Clinicians will assess patients weekly during RT and at the 2-week follow-up appointment.

Conditions

Breast Cancer; Radiation Dermatitis

Keywords

Topical; Betamethasone; Prone position

Outcome Measures

Primary Outcomes (1)

• Acute grade 2 or 3 toxicities as defined by the CTCAE v5.0 assessed by HCP

  The efficacy of the steroid, 0.1% betamethasone cream, versus the institutional standard of care in reducing acute grade 2 or 3 toxicities in patients undergoing whole or partial breast RT based on the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 assessed by HCPs, comparing changes in the treated versus non-treated breast or chest wall from baseline to weekly during radiation treatment and 2 weeks post radiation treatment. CTCAE Dermatitis Grade (higher scores mean worse outcome): 0 No symptoms, 1 Faint erythema or dry desquamation, 2 Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin fold and creases; moderate edema, 3 Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion, 4 Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated, 5 Death

  Within 3 months following radiation

Secondary Outcomes (5)

• Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)

  Within 3 months following radiation

• Clinician-assessed skin-related symptoms using the Skin Symptom Assessment (SSA)

  Within 3 months following radiation

• Photographs of treated and non-treated breast/chest wall for blind and unbiased assessment of the skin by HCPs

  Within 3 months following radiation

• Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient

  Within 3 months following radiation

• Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by HCP

  Within 3 months following radiation

Study Arms (2)

Experimental Betamethasone cream

EXPERIMENTAL

Patients randomized to the Betamethasone arm will receive the cream for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy. Patients randomized to this arm should not apply any standard of care treatments unless directed the treating radiation oncologist or nurse.

Device: Topical Betamethasone

Standard of Care Arm

NO INTERVENTION

Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy.

Interventions

Topical Betamethasone DEVICE

Betamethasone a TC, reduces RD by promoting the synthesis of anti-inflammatory proteins while also preventing other inflammatory proteins from being synthesized

Experimental Betamethasone cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
• Known sensitivity or allergy to betamethasone.
• Known pregnancy.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, 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

Study Officials

• Edward LW Chow, MBBS

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward LW Chow, MBBS

CONTACT

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

Irene karam, MDCM

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator with Dr. Danny Vesprini [dvesprini] and Dr. Irene Karam [ikaram]

Model Details: Patients receiving whole or partial adjuvant breast radiation (RT) for invasive, in situ carcinoma of the breast or phyllodes who are at increased risk of developing moderate or severe radiation dermatitis (patients with large breasts \[bra size 40 in and/or D cup or greater\] and scheduled to be treated in the prone position receiving conventionally- (50Gy/25#), hypo-fractionated (40Gy/15#), or extreme hypo-fractionated (26Gy/5#) RT will be randomized in a 2:1 ratio to receive either 0.1% betamethasone cream or moisturizer.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 8, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): December 6, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)