Topical Agents for Radiation Dermatitis in Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Disqualifiers: Partial breast irradiation, prior radiation, others

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

Compensation: Varies

Number of Visits: 7

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which cream better treats skin irritation caused by radiation therapy in breast cancer patients. It compares two creams: Aquaphor, a petrolatum-based ointment for dry skin, and Miaderm, a water-based cream with soothing ingredients like aloe vera. The goal is to determine which cream more effectively reduces itching, swelling, and discomfort. Breast cancer patients undergoing external beam radiation therapy after surgery may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on comparing two topical agents for skin reactions during radiation therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Aquaphor and Miaderm are generally safe for skin use. Aquaphor, a popular ointment, helps soothe and protect dry skin. It is widely used and usually safe, though some people might experience allergic reactions.

Studies have found that using creams like Aquaphor before radiation therapy is safe. This is important because radiation can cause skin problems, and Aquaphor helps reduce these effects.

Research suggests that Miaderm is not harmful. It contains ingredients like calendula and aloe vera, which often calm irritated skin. While some people might have mild allergic reactions, serious side effects are rare.

Both products are already used by people undergoing radiation therapy, which supports their safety. However, individual reactions can differ, so monitoring for any skin changes while using them is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Aquaphor and Miaderm as treatments for radiation dermatitis in breast cancer patients because they offer potentially soothing alternatives to standard care options like corticosteroid creams or aloe vera. Aquaphor is a well-known healing ointment that provides a protective barrier to the skin, which can help retain moisture and promote healing. Miaderm, on the other hand, is specifically formulated for radiation dermatitis and includes ingredients like aloe vera, calendula, and hyaluronic acid, which may offer additional anti-inflammatory and moisturizing benefits. By focusing on skin protection and hydration, these treatments aim to reduce the discomfort and skin damage often experienced during radiation therapy.

What evidence suggests that this trial's treatments could be effective for radiation dermatitis?

This trial will compare the effectiveness of Aquaphor and Miaderm in managing skin irritation in breast cancer patients undergoing radiation therapy. Studies have shown that patients use both Aquaphor, a petroleum-based ointment, and Miaderm, which contains calendula, hyaluronate, and aloe vera, to manage skin irritation from treatment. However, research does not strongly support Aquaphor's effectiveness in preventing skin problems specifically caused by radiation. Some studies suggest that creams like Miaderm might reduce skin damage and pain, but the evidence remains weak. More research is needed to determine which, if either, is more effective for this condition. Participants in this trial will be assigned to either the Aquaphor arm or the Miaderm arm to evaluate their effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Scott M. Glaser

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with breast cancer who've had surgery and are now getting standard radiation therapy. It's not for those with inflammatory breast cancer, skin involvement, plans to use other topical products during the study, or a history of diseases that make them extra sensitive to radiation.

Inclusion Criteria

I am receiving radiation therapy to the breast or chest wall after surgery for breast cancer.

I am older than 18 years.

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I am receiving care focused on relieving symptoms.

I have received radiation therapy to part of my breast.

I have inflammatory breast cancer with skin involvement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo external beam radiation therapy (EBRT) and apply either Aquaphor or Miaderm twice daily to the irradiated field

5-8 weeks

5-8 visits (in-person)

Post-Treatment

Participants continue applying the topical agent for 2 weeks following completion of EBRT

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for acute radiation dermatitis and quality of life

90-120 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aquaphor
• Miaderm

Trial Overview The trial compares Aquaphor (a petrolatum-based ointment) and Miaderm (a water-based cream with calendula, hyaluronate, and aloe vera) in treating acute radiation dermatitis in patients undergoing radiation therapy after breast cancer surgery.

How Is the Trial Designed?

Group I: Arm II (Miaderm) Experimental Treatment 3 Interventions

Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.

Group II: Arm I (Aquaphor) Experimental Treatment 3 Interventions

Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 23 women undergoing adjuvant radiation therapy for breast cancer, the application of vitamin D ointment (calcipotriol) did not show a significant advantage over Aqua cream in preventing radiation dermatitis.

Both treatments were well tolerated, with no allergic reactions reported, but ultimately, vitamin D ointment was not more effective than Aqua cream in reducing skin reactions during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients. Nasser, NJ., Fenig, S., Ravid, A., et al.[2022]

In a study of 126 women undergoing whole breast irradiation for breast cancer, only 4-8% experienced no skin reactions, while less than 10% developed moist desquamation, indicating that most patients had mild reactions.

The use of topical agents during treatment did not show significant benefits in healing or preventing skin reactions, but they did help improve patient comfort, with Fixomull suggested as a protective measure against moist desquamation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin reactions during radiotherapy for breast cancer: the use and impact of topical agents and dressings. Porock, D., Kristjanson, L.[2022]

In a study of 483 breast cancer patients undergoing radiotherapy, the use of a hydroactive colloid gel significantly reduced the incidence of moist desquamation (MD) to 16%, compared to 32% in those using a dexpanthenol cream.

Patients using the hydroactive colloid gel also experienced a delayed onset of MD, indicating that this treatment may be more effective in managing radiation-induced dermatitis during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol. Censabella, S., Claes, S., Orlandini, M., et al.[2022]

In a study of 100 breast cancer patients undergoing radiotherapy, those using specific hydrating creams (betaglucan, sodium hyaluronate, and Vitis vinifera) experienced significantly lower rates of cutaneous toxicity, with 80% showing mild (G0-G1) toxicity.

The study found that the type of topical treatment used was correlated with the level of skin toxicity, suggesting that certain hydrating treatments can effectively reduce the risk of skin damage during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of cutaneous damages induced by radiotherapy in breast cancer: an institutional experience. Ravo, V., Calvanese, MG., Di Franco, R., et al.[2022]

In a randomized trial involving patients receiving whole-breast radiotherapy, the preventive use of heparinoid moisturizer significantly increased skin water content and reduced dryness and desquamation compared to no moisturizer.

Patients who used the moisturizer experienced less severe pain and dryness during and after treatment, indicating that it may be an effective strategy for managing acute radiation dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of heparinoid moisturizer as a prophylactic agent for radiation dermatitis following radiotherapy after breast-conserving surgery: a randomized controlled trial. Sekiguchi, K., Akahane, K., Ogita, M., et al.[2022]

In a study of 56 breast cancer patients undergoing whole breast radiotherapy, the film-forming silicone gel StrataXRT® significantly reduced the severity of radiation dermatitis compared to the moisturizing cream X-derm®, as measured by skin parameters like the erythema and melanin indices.

The results indicate that StrataXRT® is effective in managing radiation-induced skin damage, suggesting its potential for further investigation in larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. Ahn, S., Sung, K., Kim, HJ., et al.[2020]

In a study of 76 breast cancer patients undergoing whole breast radiotherapy, it was found that radiotherapy significantly reduced sebum content in both the irradiated and non-irradiated breasts, indicating damage to the sebaceous glands.

The use of a heparinoid moisturizer after radiotherapy effectively restored sebum levels to pre-treatment amounts, suggesting it can help mitigate skin damage and water loss caused by radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Damage to sebaceous gland and the efficacy of moisturizer after whole breast radiotherapy: a randomized controlled trial. Ogita, M., Sekiguchi, K., Akahane, K., et al.[2020]

This ongoing pilot trial is evaluating the effectiveness of Jaungo, a traditional herbal ointment, in preventing radiation-induced dermatitis (RID) in 50 postoperative breast cancer patients undergoing radiation therapy, compared to a standard non-steroidal moisturizer.

The study aims to measure the incidence and severity of RID, as well as quality of life and pain related to RID, with assessments conducted by independent oncologists, providing valuable insights into the potential benefits of traditional herbal treatments in modern cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Jaungo, A Traditional Herbal Ointment, and the Water-in-Oil Type Non-Steroidal Moisturizer for Radiation-Induced Dermatitis in Patients With Breast Cancer: A Study Protocol for a Prospective, Randomized, Single-Blinded, Pilot Study. Kim, EH., Yoon, JH., Park, SB., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3935608/

Topical Hyaluronic acid vs. Standard of Care for the ... We found no benefit from use of a topical hyaluronic acid-based gel for reducing the development of grade ≥2 dermatitis after adjuvant RT for breast cancer.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01957

Comparing Supplemental Topical Agents for the Treatment ... This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05340673

Comparing Supplemental Topical Agents for the Treatment ... This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast ...

4. withpower.com withpower.com/trial/phase-1-carcinoma-intraductal-noninfiltrating-4-2022-3e4e8

Topical Agents for Radiation Dermatitis in Breast Cancer The research does not provide direct evidence supporting the effectiveness of Aquaphor, Aquaphor Healing Ointment, Petrolatum-based ointment, Miaderm, or ...

5. redjournal.org redjournal.org/article/S0360-3016(06)01684-1/fulltext

2044 The study results found that Remedy™ Skin Care products performed 14.4% better than Natural Care® Gel and Aquaphor® Healing Ointment. Furthermore, the incidence ...

6. ewg.org ewg.org/skindeep/products/920992-Aquaphor_Healing_Ointment/

EWG Skin Deep® | Aquaphor Healing Ointment Rating Ingredient concerns ; LOW. Cancer ; HIGH. Allergies & Immunotoxicity ; LOW. Developmental and Reproductive Toxicity ; HIGH. Use Restrictions ...

7. medicine.washu.edu medicine.washu.edu/news/its-safe-to-use-skin-creams-before-radiation-therapy/

It's safe to use skin creams before radiation therapy A new study demonstrates that patients can safely use skin creams before undergoing radiation therapy. This contradicts common advice from radiation ...

8. mdanderson.org mdanderson.org/content/dam/mdanderson/documents/for-physicians/algorithms/clinical-management/clin-management-skin-management-radiation-therapy-web-algorithm.pdf

Skin Management - Radiation Therapy ○ Topical steroids2 – may be applied within 1 week prior to radiation treatment, during, and 2 weeks after radiation. Do not apply to open skin.