Topical Dermaprazole for Radiation Skin Damage in Cancer Patients
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen ByMichelle S Ludwig, MD, MPH, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Michelle S Ludwig
Stay on your current meds
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a cream called Dermaprazole to prevent skin problems in patients receiving radiation therapy for head and neck or breast cancer. Patients will apply the cream throughout their radiation treatment. The study will check if the cream is safe and effective in reducing skin damage caused by radiation.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, specifically clopidogrel, St. John's Wort, rifampin, or methotrexate. If you are on any of these, you will need to discontinue them to participate.
What data supports the effectiveness of the drug Dermaprazole for radiation skin damage in cancer patients?
Research shows that Dermaprazole, a topical form of esomeprazole, effectively reduces skin inflammation and fibrosis (thickening and scarring) caused by radiation. It helps improve the appearance and healing of irradiated skin by reducing inflammation and scarring in both lab and animal studies.
12345Is Dermaprazole safe for use in humans?
Research on Dermaprazole, a topical form of the FDA-approved drug esomeprazole, shows it is effective in reducing skin inflammation and fibrosis caused by radiation, with no reported safety concerns in the studies conducted.
14678How does the drug Dermaprazole differ from other treatments for radiation skin damage?
Dermaprazole is unique because it is a topical formulation of esomeprazole, a drug typically used for other conditions, and it works by reducing inflammation and fibrosis (thickening and scarring of tissue) in the skin. It activates specific protective pathways in the skin, which helps heal radiation-induced skin damage more effectively than current options.
13469Eligibility Criteria
The TOPAZ trial is for adults with head and neck cancer or breast cancer who are undergoing radiation therapy. Eligible participants include those with specific types of these cancers, confirmed within the last 2 years, and planned to receive a certain dose of radiation. They must be in good enough health to participate as judged by their ECOG status. People can't join if they have had prior radiotherapy in the same area, are pregnant or breastfeeding, have certain medical conditions like active infections or collagen vascular diseases, allergies to proton pump inhibitors, or use specific medications.Inclusion Criteria
I am scheduled for chest wall radiation of at least 40Gy.
I am scheduled for chemoradiation with a high-dose plan.
I am 18 years old or older.
I am a woman who had breast cancer and underwent a type of mastectomy.
I am 18 years old or older.
I can care for myself and am up and about more than 50% of my waking hours.
Exclusion Criteria
My biopsy shows cancer on the skin or at the edge of the surgery area.
I do not have any serious conditions that would make the study drug unsafe for me.
I do not have any serious health issues that would make it unsafe for me to take the study drug.
I have had radiotherapy to the chest before.
I have had radiotherapy for head or neck cancer before.
I am not currently receiving chemotherapy.
I am currently taking clopidogrel, St. John's Wort, rifampin, or methotrexate.
I have an active collagen vascular disease like lupus, scleroderma, or dermatomyositis.
I have an open wound at the time of my treatment planning.
I have an open wound from surgery that hasn't healed for more than 8 weeks.
I have a condition like lupus, scleroderma, or dermatomyositis.
I am currently taking clopidogrel, St. John's Wort, rifampin, or methotrexate.
I am currently receiving chemotherapy.
Participant Groups
This study tests Dermaprazole cream at two different strengths (1% and 2%) for preventing skin damage caused by radiation therapy in patients with breast cancer post-mastectomy or head and neck cancer. The trial aims to assess how safe and tolerable this treatment is (Phase I) as well as its initial effectiveness (Phase II).
4Treatment groups
Experimental Treatment
Group I: Dermaprazole 2% (Arm B: Breast)Experimental Treatment1 Intervention
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Group II: Dermaprazole 2% (Arm A: Head and neck)Experimental Treatment1 Intervention
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Group III: Dermaprazole 1% (ArmB: Breast)Experimental Treatment1 Intervention
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Group IV: Dermaprazole 1% (Arm A:Head and neck)Experimental Treatment1 Intervention
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Harris Health System - Smith ClinicHouston, TX
Baylor College of Medicine Medical Center - McNair CampusHouston, TX
Baylor St. Luke's Medical CenterHouston, TX
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Who is running the clinical trial?
Michelle S LudwigLead Sponsor
References
Non-Invasive Physical Plasma for Preventing Radiation Dermatitis in Breast Cancer: A First-In-Human Feasibility Study. [2022]Radiation dermatitis (RD) is the most common acute side effect of breast irradiation. More than a century following the therapeutic utilisation of X-rays, potent preventative and therapeutic options are still lacking. Non-invasive physical plasma (NIPP) is an emerging approach towards treatment of various dermatological disorders. In this study, we sought to determine the safety and feasibility of a NIPP device on RD. Thirty patients undergoing hypofractionated whole-breast irradiation were included. Parallel to radiation treatment, the irradiated breast was treated with NIPP with different application regimens. RD was assessed during and after NIPP/radiation, using clinician- and patient-reported outcomes. Additionally, safety and feasibility features were recorded. None of the patients was prescribed topical corticosteroids and none considered the treatment to be unpleasant. RD was less frequent and milder in comparison with standard skin care. Neither NIPP-related adverse events nor side effects were reported. This proven safety and feasibility profile of a topical NIPP device in the prevention and treatment of RD will be used as the framework for a larger intrapatient-randomised double-blind placebo-controlled trial, using objective and patient-reported outcome measures as an endpoint.
Prevention and management of radiation-induced dermatitis, mucositis, and xerostomia. [2019]Current strategies for preventing and managing radiation-induced dermatitis, mucositis, and xerostomia are reviewed, with an emphasis on pharmacologic interventions.
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.
Topical Esomeprazole Mitigates Radiation-Induced Dermal Inflammation and Fibrosis. [2020]Radiation therapy is a mainstream strategy in the treatment of several cancer types that are surgically unresectable. Unfortunately, cancer patients often suffer from unintended consequences of radiotherapy, including the development of skin inflammation (dermatitis), which may progress to fibrosis. These morbid complications often require interruption of radiotherapy and threaten the relapse of underlying cancer. Current treatment options for radiation dermatitis are suboptimal and compel the need to develop safer, more effective therapies. In this study, we assessed the biophysical properties of topically-formulated esomeprazole (here referred to as dermaprazole) and performed proof-of-concept studies to evaluate its efficacy in vitro and in vivo. We found that dermaprazole induced nuclear translocation of erythroid 2-related factor 2 (Nrf2) and significantly upregulated heme oxygenase 1 (HO1) gene and protein expression in a 3D human skin model. Our animal study demonstrated that dermaprazole improved macroscopic appearance of the irradiated skin and accelerated healing of the wounds. Histopathology data corroborated the photographic evidence and confirmed that both prophylactically and therapeutically administered dermaprazole conferred potent anti-inflammatory and antifibrotic effects. Gene expression data showed that dermaprazole downregulated several pro-oxidant, pro-inflammatory and profibrotic genes. In conclusion, topical formulation of the FDA-approved drug esomeprazole is highly effective in attenuating dermal inflammation and fibrosis.
Management of acute radiation dermatitis: A review of the literature and proposal for treatment algorithm. [2019]Radiation dermatitis is a common sequela of radiation therapy; up to 95% of patients will develop moderate-to-severe skin reactions. No criterion standard currently exists for the treatment of acute radiation-induced skin toxicity. It is therefore imperative to develop a greater understanding of management options available to allow clinicians to make informed decisions when managing radiation oncology patients. This literature review discusses the topical agents that have been studied for the treatment of acute radiation dermatitis, reviews their mechanisms of action, and presents a treatment algorithm for clinicians managing patients experiencing radiation dermatitis.
Radiation recall dermatitis after docetaxel chemotherapy. Treatment by antioxidant ointment. [2021]Radiation recall dermatitis (RRD) is an acute skin toxicity caused by different anticancer or antibiotic drugs within a former completely healed irradiation field. Predictive factors for RRD are not known and its mechanisms are not completely understood. A case of RRD induced by docetaxel and successfully treated by an antioxidant ointment (Mapisal(®)) is presented here. Such an ointment might be useful not only in RRD therapy, but also in the treatment of high-grade dermatitis induced by radiotherapy and thus may contribute to the improvement of patients' quality of life and to the scheduled completion of cancer therapies.
Normal tissue reactions in mice after combined treatment with metoclopramide and ionizing radiation. [2019]We have previously shown that metoclopramide potentiates the effect of ionizing radiation and cisplatin treatment of human squamous cell carcinomas from the head and neck region xenografted to nude mice. In the present tumor study, the dose scheduling of metoclopramide in combination with radiation was evaluated, and metoclopramide was shown to be most effective in potentiating the cytotoxic effect of radiation when administered one hour before radiation. The effect of radiation in combination with metoclopramide on normal tissue was also studied in two well-established models. Acute skin reactions to radiation exposure were studied in 129-type mice, and metoclopramide did not enhance the acute skin reaction in this in vivo model. Survival after whole body irradiation was studied in heterozygote Balb/c nu/+ mice as a measure of bone marrow toxicity. Metoclopramide was not found to affect the LD50/30 in this in vivo model. The absence of potentiation of radiation damage to normal tissue in these animal studies, makes metoclopramide an interesting possibility for future clinical evaluation.
Effect of cancer chemotherapeutic drugs on the radiation-induced skin reactions in mouse feet. [2006]The interactions of seven cancer chemotherapeutic drugs and radiation in normal skin were studied using the mouse foot skin scoring system. Single drug doses were administered 15 min before graded single doses of irradiation or at different intervals before and after a fixed radiation dose. Adriamycin (ADM), bleomycin (BLM), methotrexate (MTX), mitomycin-C (MM-C), and cis-platinum (cis-DDP) all significantly enhanced the radiation-induced skin reactions. The dose-effect factors (DEF) for these drugs ranged from 1.07 to 1.11. Cyclophosphamide (CTX) had a radioprotective effect (DEF 0.90), whereas 5-fluorouracil (5-FU) had no effect (DEF 1.00). The effect of ADM was present at administration from 6 h before to 2 min after irradiation, and the effect of BLM from 24 h before to 4 h after irradiation. The radioprotective effect of CTX and the enhanced effect of MM-C were only present on administration 15 min before and 2 min after irradiation. MTX and cis-DDP enhanced the skin reactions only when given before irradiation.
Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial. [2020]Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis.