EGFR-Is (Epidermal Growth Factor Inhibitors) such as cetuximab, panitimumab and RTK (Receptor Tyrosine Kinase) such as erlotinib, regorafenib are “Targeted Therapies” with a selective capacity. However their use causes new side effects, such as the skin toxicity, the most prevalent of which is the maculo-papular rash. Several studies emphasize that education and prevention can reduce this toxicity which, if not treated promptly, may compromise the ongoing chemotherapy treatment and have a negative impact on the patient's QoL.
This is a randomized mono center, two-treatment arms and interventional study. 178 patients, enrolled in approximately 2 years, will be randomized 1:1 to receive intravenous treatment (Cetuximab or Panitumumab) or oral treatment (Erlotinib or Regorafenib). All patients, in Arm A (experimental group) and in Arm B (control group), will complete a HOC Questionnaire Created composed by 14 items and Dermatology Life Quality Index (DLQI). Furthermore, it will be created a HOC brochure by nurses containing advice and information about the skin toxicities and their management. Questionnaires, brochure and interviews will be administered as shown in the table. Note: a and b only Arm ATable: CN52
|Study period||Screening phase (-14 to -1)||Every 4 weeks (until at first tumor assessment)|
|Informed Consent Form||X|
|HOC Questionnaire Created||X|
|Interview with nurseb||X||X|
The sample size will be hypothetical that the incidence of cutaneous toxicity in the Arm A group, will be lower than that of the Arm B group as per CTCAE 5.0. It will be considered clinically relevant to observe a better QoL and a 20% reduction in the incidence of cutaneous toxicity in the Arm A and a redistribution of toxicity levels such as to produce an effect size of 0.068.
Allowing patients to be more involved in their treatment and toxicity management of toxicities related, oncology nurses can help them to maintain their QoL and to promote adherence to treatment. The project hopes to confirm the hypothesis of cutaneous toxicity reduction 20% in Arm A and a better QoL compared to Arm B (control group).
Clinical trial identification
Legal entity responsible for the study
Istituto Oncologico Veneto.
Has not received any funding.
All authors have declared no conflicts of interest.