Abstract
Objective: Immunotherapy can be accompanied by cutaneous adverse events that negatively impact the patient's quality of life (QoL). This trial aimed to evaluate the efficacy of two novel skin care products in preventing and managing cutaneous adverse events associated with immunotherapy. Methods: An interventional, open-label, single-group, pretest-posttest study was conducted at the Jessa Hospital (Belgium) involving cancer patients receiving immunotherapy (n=75). Patients applied the skin care products daily for three weeks. A researcher evaluated skin toxicity using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. Questionnaires assessed the frequency and severity of their symptoms (Numeric Rating Scale, NRS), the patient's QoL (Dermatology Life Quality Index, DLQI, and Skindex-29), the Patient Benefit Index, and patient satisfaction (NRS). Results: The CTCAE and NRS showed that pruritus and xerosis were the most frequently observed skin toxicities. According to the NCI-CTCAE, an improvement was detected in the grade of pruritus and xerosis after applying the novel emollients (P<0.001). All patient-reported symptoms decreased significantly in frequency. Both the Skindex-29 total score (P<0.001) and DLQI (P=0.038) improved over time. Moreover, 42.7% of the patients experienced at least one patient-relevant benefit of the treatment. Lastly, 70.7% of the patients were satisfied with the products, and 74.6% would recommend them to other patients. Conclusion: This trial demonstrates that the two novel emollients effectively alleviate immunotherapy-related dermatological toxicities. As a result, an improvement in the patient's QoL was observed, accompanied by high satisfaction and a strong likelihood of recommendation. Future research with a control group is necessary to draw firm conclusions.