Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Dimenhydrinate

Antioxidants

Emollients

All patients will receive the experimental emollient during 3 weeks.

The emollient is hypo-allergenic, free of perfume and has very high hydrating capacities together with antioxidants.

Self-prepared emollient

Jeroen Mebis, MD, PhD

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 chemotherapeutic agents. The chemotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival.

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 ChemoSkin project, a novel emollient to tackle the cutaneous adverse events of chemotherapy has been developed.

The ChemoSkin project general aim is to evaluate the efficacy of a novel skincare product to manage chemotherapy-related cutaneous toxicities.

Primary objective Evaluate the efficacy of a novel emollient for the management of chemotherapy-related cutaneous adverse events

Secondary objective 1 Evaluate patient-relevant treatment benefit of the novel emollient for chemotherapy-associated cutaneous toxicities

Secondary objective 2 Evaluate the influence of the novel emollient for chemotherapy- associated cutaneous toxicities on the patient's quality of life

Secondary objective 3 Evaluate the safety of the novel emollient for chemotherapy- associated cutaneous toxicities

Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities

Evaluation of a Novel Skin Care Product for the Management of Chemotherapy- Related Dermatologic Toxicities

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regimen).

The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

The Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:

1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective.
2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.

The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products by using a numerical rating scale.

Hasselt University

Jessa Hospital

Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Rare Diseases

Dermatitis

Breast Neoplasms

Radiodermatitis

Skin Diseases

Radiation Injuries

Acute Graft Versus Host Disease

Histamine Antagonists

Will receive the standard institutional skin care for acute radiodermatitis

Will receive the novel, self-prepared skin care product

The emollient has a calming effect, and hydrating and anti-oxidative properties.

An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Hydrating emollient for acute radiodermatitis

The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Standard institutional skin care

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.

Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients

Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Novel Skin Care Product for the Management of Acute Radiodermatitis

Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.

The patients skin reactions will be evaluated by the modified version of the RTOG criteria

The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).

The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities	NCT04929847	Skin Toxicity	Self-prepared e...	18 Years -	Jessa Hospital
Novel Skin Care Product for the Management of Acute Radiodermatitis	NCT04929808	Radiodermatitis... Radiation Derma...	Hydrating emoll... Standard instit...	18 Years -	Jessa Hospital

Spots Global Cancer Trial Database for emollient

Every month we try and update this database with for emollient cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for emollient

Every month we try and update this database with for emollient cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for emollient cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.