Topical Betamethasone for Prevention of Radiation Induced Dermatitis

Overseen By Edward LW Chow, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Brachytherapy, Bilateral radiation, Active rash, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3-5 weeks

276 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called betamethasone to determine its effectiveness in preventing skin problems caused by radiation therapy in breast cancer patients. The focus is on large-breasted women, who are more prone to these skin issues, including itching, swelling, and redness. Participants will either use the betamethasone cream or follow standard skin care routines during their treatment. Women with a bra size of 40 inches or D cup or larger, who are receiving radiation therapy on their breast, may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on cytotoxic chemotherapy, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that betamethasone cream is generally safe for use. Studies have found that this cream can reduce skin damage from radiation therapy with minimal side effects. Betamethasone lowers inflammation, helping to prevent or lessen skin irritation caused by radiation. Patients in past studies handled it well, with few reports of negative reactions. Thus, betamethasone is considered effective and well-tolerated for managing skin problems related to radiation treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Betamethasone cream for preventing radiation-induced dermatitis because it offers a proactive approach to managing skin damage during radiotherapy. Unlike standard treatments, which typically address symptoms after they appear, Betamethasone cream may help prevent the irritation and peeling from the start. Betamethasone is a potent corticosteroid that reduces inflammation and can be applied topically, potentially making it more effective and convenient than some current options like gentle skin moisturizers or aloe-based creams. This could mean less discomfort and better quality of life for patients undergoing radiation therapy.

What evidence suggests that betamethasone might be an effective treatment for radiation dermatitis?

Research has shown that topical betamethasone effectively reduces skin damage caused by radiation, known as radiation dermatitis. In this trial, participants in the Betamethasone arm will receive the cream during their radiation treatment. Studies have found that betamethasone can decrease the severity of skin problems by half when applied while lying on one's back. Betamethasone reduces inflammation and is well absorbed by the skin, resulting in fewer side effects. It is also more affordable than some other treatments. This suggests that betamethasone could greatly benefit patients undergoing radiation therapy by lowering the risk of serious skin issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Edward LW Chow, MBBS

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for breast cancer patients with large breasts (band size ≥ 40 or cup size ≥ D) who will receive radiation therapy while lying on their stomach. Participants must be willing to apply a cream daily during and up to two weeks after treatment. Those receiving various types of radiation schedules are included, but the study excludes certain skin types and those needing specific boosts.

Inclusion Criteria

I am female.

My breast cancer diagnosis has been confirmed by tissue examination.

I have large breasts and had surgery to remove part of one breast.

Exclusion Criteria

Known sensitivity or allergy to betamethasone

Known pregnancy

I have a rash or skin condition in the area to be treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 0.1% betamethasone cream or standard of care during radiation treatment

3-5 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 weeks post-RT in-person, 6 weekly assessments, and a 3-month telephone follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Betamethasone

Trial Overview The trial tests if betamethasone cream can better prevent skin irritation from radiation compared to standard care in large-breasted women treated face down. It's randomized, meaning patients are put into groups by chance, with more getting betamethasone than standard care.

How Is the Trial Designed?

Group I: Experimental Betamethasone cream Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study of 191 breast cancer patients, three topical agents (Curcumin, HPR Plus™, and a placebo) were tested for their effectiveness in preventing radiation dermatitis, but no significant differences in skin reaction severity were found among the groups overall.

However, in patients with a high breast field separation (≥ 25 cm), curcumin showed potential benefits in reducing skin reactions and pain, suggesting it may be particularly helpful for those at greater risk of severe dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial. Ryan Wolf, J., Gewandter, JS., Bautista, J., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915857

Topical Betamethasone Versus Moisturizer in Preventing ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40973558/

Efficacy of Topical Betamethasone Valerate and Olive Oil ... Aim: The purpose of this study is to compare topical betamethasone-17-valerate and olive oil cream in preventing radiation-induced dermatitis ( ...

3. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(25)00235-6/abstract

Efficacy of Topical Betamethasone Valerate and Olive Oil ... The purpose of this study is to compare topical betamethasone-17-valerate and olive oil cream in preventing radiation-induced dermatitis ...

4. ijdvl.com ijdvl.com/topical-betamethasone-for-prevention-of-radiation-dermatitis/

Topical betamethasone for prevention of radiation dermatitis We also found that petrolatum has no effect on the prevention of radiation-induced acute dermatitis. We acknowledge the possible drawbacks of this study. Chest ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002356

Efficacy of Topical Betamethasone Valerate and Olive Oil ... The purpose of this study is to compare topical betamethasone-17-valerate and olive oil cream in preventing radiation-induced dermatitis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6306060/

Radiation-induced skin reactions: mechanism and treatment A randomized study with betamethasone and two moisturizing creams showed that the control of acute radiation dermatitis with betamethasone cream for breast ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00063-9/fulltext

MASCC clinical practice guidelines for the prevention and ... Anti-inflammatory cream reduces skin damage induced by ionizing radiation ... betamethasone cream for those at high risk of radiation dermatitis.