Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Dermatitis

Breast Neoplasms

Radiodermatitis

Skin Diseases

Radiation Injuries

Receives institutional skin care protocol

Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy

Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful

Low-Level Laser Therapy

Jeroen Mebis, MD, PhD

Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.

LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.

Laser Therapy for the Management of Radiation Dermatitis

Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients

objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC).

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

evaluation of pain using a visual analogue scale

Health-related quality of life measure specific to skin diseases (Skindex-16)

Self-report on the impact of radiation dermatitis on daily activities

Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis

Hasselt University

MD, PhD

Behaviors and Mental Disorders

Exanthema

Quality of Life

All Drugs and Chemicals

Micronutrients

Mitogens

Provitamins

Vitamins

Trace Elements

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

dexpanthenol 5% cream

Cetomacrogol cream

Christine Boers-Doets, MSc

Mario Lacouture, MD

Johan Nortier, PhD

Objective:

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period. The adherence to the study creams will also be studied.

Rationale:

Dermatological side effects, such as papulopustular eruption, xerosis, pruritus, periungual inflammation, mucosal-, and hair abnormalities, and edema occur in up to 90% of patients during treatment with epidermal growth factor receptor inhibitors (EGFRI). Patients are hindered in their daily activities and cannot maintain privacy about their illness because of the prominent side effects. The aesthetic discomfort, which is frequently associated with itching or painful skin or nails can lead to a decreased health related quality of life (HRQoL) and to dose reduction or discontinuation of anticancer treatment.

Patients with dermatological side effects have also an increased risk for cutaneous infections (at least 38%) which can complicate dermatological side effects.

At present, evidence of the effectiveness of the management options for dermatological side effects is lacking, and the effect of the dermatological side effects on HRQoL and adherence remains poorly understood.

Dexpanthenol cream (Bepanthen®, Bayer) has been used extensively to ameliorate acute radiation induced skin toxicity, diaper dermatitis, irritant hand dermatitis, graft-donor site wound healing and burn patients. The hypothesis is that its skin healing possibilities decreases this kind of side effects.

Study design:

Multicenter, two-arm randomized, double blind, prospective parallel group design, phase III study

Study population:

Each patient starting for the first time with EGFRI anticancer therapy which can cause papulopustular eruption (cetuximab, panitumumab, erlotinib, gefitinib, lapatinib, or other), will be included.

Intervention:

80 patients will receive for the first 6 weeks of treatment Bepanthen cream, 80 patients Cetomacrogol cream to apply twice daily. Using FACT-EGFRI, a dermatology-specific questionnaire, this study examines the effect of these side effects on three domains of HRQoL - symptoms, emotions, and functioning. Severity of dermatological side effects will be assessed using the NCI-CTCAE v4.0. Correlation of dermatology HRQoL scores with NCI-CTCAE grade, sex, age, type of EGFRI, and cancer type will be conducted.

Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular Eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

The incidence of grade ≥ 2 papulopustular eruption during the 6 week skin treatment within Bepanthen and Cetomacrogol, as measured by the CTCAE v4.0 and DERETT-H, an dermatologic specific healthcare provider questionnaire for Dermatological Reactions Targeted Therapy.

Assess the impact of papulopustular eruptions on HRQoL as measured by the Functional Assessment of Cancer Therapy Questionnaire - EGFRI (FACT-EGFRI) and newly developed symptom experience diary Dermatological Reactions Targeted Therapy - Patients (DERETT-P).

Determine the patient tolerability and satisfaction of Bepanthen®/ Cetomacrogol cream as measured by DERETT-P.

Determine the effectiveness of Bepanthen® cream versus Cetomacrogol cream on the adherence to anticancer agents as measured by FACT-EGFRI and DERETT-P.

Assessments during the 6-week skin treatment period of the incidence and time to onset of other dermatological side effects which can appear together with papulopustular eruptions as measured by DERETT-H.

CB Boers ORG

Memorial Sloan Kettering Cancer Center

Leiden University Medical Center

Bayer

Impaqtt Foundation

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Immunomodulating Agents

Dimenhydrinate

Diphenhydramine

Promethazine

Emollients

All patients will receive the experimental emollients during 3 weeks.

Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Hydrating emollient + body lotion for immunotherapy-related side effects

Jolien Robijns, 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 immunomodulatory agents. The immunotherapy-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 ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed.

The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.

Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events

Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities

Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life

Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities

Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

Evaluation of Novel Skin Care Products for the Management of Immunotherapy- 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, dosing etc).

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients

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) 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.

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 using a numerical rating scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laser Therapy for the Management of Radiation Dermatitis	NCT01932073	Radiation Derma...	Low-Level Laser...	-	Hasselt University
Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)	NCT01136005	Cancer Skin Rash	dexpanthenol 5%... Cetomacrogol cr...	18 Years -	Impaqtt Foundation
Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities	NCT04929834	Skin Toxicity Immunotoxicity	Hydrating emoll...	18 Years -	Jessa Hospital

Spots Global Cancer Trial Database for skin reactions