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Radiodermatitis clinical trials

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NCT ID: NCT05284487 Recruiting - Clinical trials for Radiation-induced Dermatitis

Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.

JALOSOME-01
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Primary objective - To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT. Secondary objectives: - To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo. - To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life. - To investigate safety and tolerability of Jalosome®. - To investigate patient's compliance to Jalosome® treatment. - To investigate patient's global satisfaction with Jalosome® treatment.

NCT ID: NCT05269160 Recruiting - Breast Cancer Clinical Trials

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ)

Start date: April 24, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Radiotherapy is a mainstay of treatment in head and neck cancer and breast cancer treatment, typically following surgery and/or chemotherapy. Radiation dermatitis, which involves redness, dryness, and/or peeling of the skin, occurs in up to 95% of patients receiving radiation therapy. There is currently no standard therapy for this treatment-related adverse effect. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream ( termed "Dermaprazole") in patients who require radiation for either breast cancer in the postmastectomy setting or head and neck cancer in the definitive or adjuvant setting.

NCT ID: NCT05190770 Recruiting - Breast Cancer Clinical Trials

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.

NCT ID: NCT05114226 Not yet recruiting - Clinical trials for Radiation-Induced Dermatitis

A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury

Start date: March 1, 2022
Phase: Phase 1
Study type: Interventional

This study was a single-center prospective phase I clinical study to evaluate the effectiveness and safety of BH4 in the treatment of radiation-induced skin injury during vulvar cancer radiotherapy.

NCT ID: NCT05079763 Recruiting - Clinical trials for Acute Radiation Dermatitis

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.

NCT ID: NCT05073172 Withdrawn - Breast Carcinoma Clinical Trials

StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.

NCT ID: NCT05032768 Recruiting - Breast Cancer Clinical Trials

The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients

Start date: January 1, 2021
Phase:
Study type: Observational

The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of 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: NCT04992650 Enrolling by invitation - Clinical trials for Breast Reconstruction

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).

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.