Topical Agents for Radiation Dermatitis in Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: City of Hope Medical Center
Disqualifiers: Partial breast irradiation, prior radiation, others
No Placebo Group
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.
12345Is 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.
12367How 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.
12358Eligibility 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.
+4 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Arm II (Miaderm)Experimental Treatment3 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 Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients. [2022]Radiation dermatitis occurs frequently during adjuvant radiation therapy for breast cancer. Prevention of radiation dermatitis by applying various creams and ointments has a limited success, and Aqua cream which has urea as one of its active ingredients is used in many institutions as a preventive treatment. The primary goal of this study is to assess the effect of vitamin D (calcipotriol) ointment in prevention of radiodermatitis in breast cancer patients compared to Aqua cream. Twenty-three women with localized breast cancer who underwent breast-conserving surgery and opted to receive adjuvant radiotherapy to breast only were enrolled in this study. A cream containing an active vitamin D analog, calcipotriol (Daivonex), was randomly applied either to the medial or to the lateral half of the irradiated breast, while Aqua cream was applied to the complimentary half of the same breast along the whole treatment days, each day, after the delivery of radiation. Skin reaction was recorded and compared between the two halves of the breast. Vitamin D was well tolerated by patients with no local or systemic allergic reactions. Radiation dermatitis was not significantly different between both treatment arms. Topical vitamin D ointment is not superior to Aqua cream for prevention of radiation-induced dermatitis in women treated with adjuvant radiation for breast cancer.
Damage to sebaceous gland and the efficacy of moisturizer after whole breast radiotherapy: a randomized controlled trial. [2020]We conducted a randomized trial to evaluate the efficacy of heparinoid moisturization for radiation dermatitis. We report the time-course of sebum content after whole breast radiotherapy (WBRT) and the efficacy of heparinoid moisturizer.
Skin reactions during radiotherapy for breast cancer: the use and impact of topical agents and dressings. [2022]Radiation skin reactions occur in the majority of cases of patients undergoing radiotherapy for breast cancer with varying degrees of severity. Guidelines for skin care and for the use of topical agents and dressings have developed over the years of practice but there is little empirical evidence on which to base a decision for best practice. This paper describes the incidence of radiation skin reactions in a sample of 126 women treated for breast cancer post-lumpectomy. The results show that by the end of whole breast irradiation between 4-8% of patients will have no reaction and less than 10% will have moist desquamation as measured by the RTOG acute scoring system. The majority of patients did not require application of a topical agent during the treatment period. Statistical analysis of relationships between the severity of radiation skin reaction and the use of topical agents found no support for additional healing or preventative benefit. However, these topical agents were found to promote comfort. The use of Fixomull as a protector and potential preventive measure for moist desquamation is described.
Efficacy of heparinoid moisturizer as a prophylactic agent for radiation dermatitis following radiotherapy after breast-conserving surgery: a randomized controlled trial. [2022]The application of heparinoid moisturizer for 2 weeks following whole-breast radiotherapy (WBRT) was previously reported to significantly increase skin water content (WC) and help improve skin dryness and desquamation. The prospective open-label, randomized trial included an exploratory arm to investigate the preventive efficacy of heparinoid moisturizer for acute radiation dermatitis (ARD).
Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol. [2022]Dermatitis is a very frequent and distressing side effect of radiation therapy that may necessitate a treatment interruption when evolving towards more severe forms such as moist desquamation (MD). The aim of this study was to compare the efficacy of two topical agents, a dexpanthenol cream vs a hydroactive colloid gel combining absorbing and moisturising properties, in preventing MD in breast cancer patients.
Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. [2020]To evaluate whether topical use of a film-forming silicone gel (StrataXRT®) could reduce radiation dermatitis compared to a moisturizing cream (X-derm®) in patients receiving whole breast radiotherapy.
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]Background: Radiation-induced dermatitis (RID) is a common complication of radiation therapy (RT). Although it has a high prevalence and can even trigger the premature end of conventional cancer therapies, there is no standard management. This study aims to evaluate whether topical use of Jaungo (Shiunko), a traditional herbal ointment mainly composed of Lithospermi radix and Angelica sinensis, could reduce RID compared to the water-in-oil type non-steroidal moisturizer in patients with breast cancer. Methods: This is a prospective, single-blinded, randomized controlled pilot trial that investigates the effect of topical application of Jaungo for the prevention of RID in postoperative breast cancer patients scheduled for RT, in comparison with the non-steroidal moisturizer, with a random distribution of 50 patients across the two groups. RT will be administered for 5-7 weeks with a biological equivalent dose (BED10) of 60 Gy or more, and the interventions will be applied 3 times a day during RT duration. Participants will be assessed a total of nine times, including eight visits during the period of RT and one visit at a 2-week follow-up period after the end of treatment. The incidence and severity of RID, quality of life, skin reaction symptoms, and maximum pain related to RID will be measured. The incidence rate of grade 2 or higher RID using the Radiation Therapy Oncology Group (RTOG) in the two groups will be statistically compared as the primary outcome. The types and frequencies of adverse events will be also collected and evaluated. All assessments will be performed by independent radiology oncologists. Discussion: This trial is currently ongoing and is recruiting. This study will determine the preventive efficacy of Jaungo in RID with postoperative breast cancer patients and provide evidence in traditional Korean medicine clinical practice.
Prevention of cutaneous damages induced by radiotherapy in breast cancer: an institutional experience. [2022]A minimal part of patients treated with radiotherapy on the entire breast may present an acute, subacute or chronic cutaneous damage of the healthy tissues involved in the radiation fields. The aim of this retrospective study was to evaluate the most efficient topical hydrating treatment in the prevention of cutaneous radio-induced acute effects in breast cancer.