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Radiodermatitis clinical trials

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NCT ID: NCT06133218 Completed - Breast Neoplasms Clinical Trials

Patient Reported Outcomes Using Mepitel Film During Radiotherapy

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand randomized controlled trial (RCT) investigated the prophylactic use of safetac-based film, Mepitel Film, on half of the breast during RT compared to cream, resulting in significant differences in skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark toward lower total RT doses, the level of RT-induced skin toxicity could still be of great importance for the patients. The aim of this study is patient-reported symptoms and patient-reported experiences with the prophylactic use of Mepitel Film compared to standard cream treatment.

NCT ID: NCT06001463 Completed - Clinical trials for Radiation Dermatitis

Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).

NCT ID: NCT05810194 Completed - Clinical trials for Radiation Dermatitis

Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

Start date: May 1, 2023
Phase:
Study type: Observational

Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.

NCT ID: NCT05693597 Completed - Clinical trials for Radiation Dermatitis

Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients

Start date: January 24, 2023
Phase: Phase 2
Study type: Interventional

Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. Nigella sativa is an herbal medicine whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Nigella sativa as a prophylactic method against the development of RID.

NCT ID: NCT05557825 Completed - Clinical trials for Head and Neck Cancer

The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients

Start date: January 20, 2023
Phase:
Study type: Observational

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis treated with PBM and/or PDT. This is a case series report and the study data will be extracted from the medical records of four head and neck cancer patients with grade 2 to 4 followed up from 2021 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT therapy. Data with positive or negative results will be reported.

NCT ID: NCT05450848 Completed - Clinical trials for Radiation Dermatitis

StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.

NCT ID: NCT04995328 Completed - Clinical trials for Radiation Dermatitis

Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel

Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The radiotherapy after surgery reduces the risk of recurrence and death is widely used for standard treatment for cancer including breast cancer and head and neck cancer. However, radiation dermatitis is a common side effect and major adverse event of radiotherapy. Radiation induces skin inflammation resulting in redness, itchiness and peeling skin. Radiation dermatitis may be acute or chronic. Acute skin changes occur within 90 days of initiating therapy due to inflammation and DNA damage and chronic skin changes may occur after several weeks or years. Radiation-irritated skin is a treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin structure and causes a variety of symptoms of cuticle thinning, reducing of collagen in subcutaneous, sweat glands damage, sebaceous glands damage and basal membrane damage. These conditions lead patients to lost work productivity, wound care costs, social isolation, altered body image and affect a patient's quality of life and mental health both during and after treatment and even interrupts the treatment schedule. The treatment of radiation dermatitis is an essential component of radiotherapy. The common treatment includes agents and other dressing products, such as corticosteroid cream, hyaluronic acid, aloe and sucralfate, which are used to prevent or reduce severity of dermatitis. But there is no clear therapeutic or nursing guideline supporting continuous treatment of radiation dermatitis by topical agents currently. In this study, Radiation Care® gel which contain Japanese honeysuckle extract will be used in breast and head and neck cancer patients to test the safety and efficacy to prevent radiation dermatitis and alleviate their radiation-irritated skin symptoms. The primary objective of this study is to evaluate the clinical outcomes of "Radiation Care" gel application in breast cancer and head and neck cancer patients who have radiation dermatitis or radiation-irritated skin due to the radiotherapy.

NCT ID: NCT04929808 Completed - Clinical trials for Radiation Dermatitis

Novel Skin Care Product for the Management of Acute Radiodermatitis

RTSkin
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT. Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed. The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

NCT ID: NCT04483856 Completed - Radiodermatitis Clinical Trials

Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.

DRESDA
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion. The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period

NCT ID: NCT04261387 Completed - Clinical trials for Radiation Dermatitis

LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Start date: January 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.