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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and general discomfort. Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations. Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis. Both are commonly recommended and used by breast cancer patients undergoing external beam radiation therapy (EBRT). However, it is not known whether one is better than the other in treating or preventing radiation dermatitis.

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.

What data supports the effectiveness of the treatment Aquaphor, Aquaphor Healing Ointment, Petrolatum-based ointment, Miaderm, Miaderm Radiation Relief Lotion for radiation dermatitis in breast cancer patients?

The research does not provide direct evidence supporting the effectiveness of Aquaphor, Aquaphor Healing Ointment, Petrolatum-based ointment, Miaderm, or Miaderm Radiation Relief Lotion for radiation dermatitis in breast cancer patients. However, it mentions that topical agents can promote comfort during treatment, even if they do not significantly prevent or heal radiation skin reactions. ^{1 2 3 4 5}

Is it safe to use topical agents like Aquaphor for radiation dermatitis in breast cancer patients?

The research does not provide specific safety data for Aquaphor or similar topical agents like Miaderm, but it suggests that these types of products are generally used to promote comfort during radiation therapy without significant adverse effects. ^{1 2 3 6 7}

How does the topical treatment for radiation dermatitis in breast cancer differ from other treatments?

The topical treatment using vitamin D ointment (calcipotriol) for radiation dermatitis in breast cancer is unique because it involves an active vitamin D analog, which is not commonly used in standard treatments. However, studies show it is not more effective than Aqua cream, which contains urea, in preventing radiation-induced skin damage. ^{1 2 3 5 8}

Research Team

Scott M. Glaser

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Damage to sebaceous gland and the efficacy of moisturizer after whole breast radiotherapy: a randomized controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

5. Scotland 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. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. [2020]

7. Switzerland 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of cutaneous damages induced by radiotherapy in breast cancer: an institutional experience. [2022]