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EONS Poster diplay

5777 - EONS Poster - Pilot Study – Nurses' Role in Management of Cutaneous Toxicity in Patients with Targeted Therapies Anti EGFR-Is' Treatment.

Date

22 Oct 2018

Session

EONS Poster diplay

Topics

Supportive Care and Symptom Management

Tumour Site

Presenters

Orejeta Diamanti

Citation

Annals of Oncology (2018) 29 (suppl_8): viii695-viii697. 10.1093/annonc/mdy277

Authors

O. Diamanti1, T.M. Zacheo2, C. Lando1, C. Magro1, G. Pauletti1, E. Zemella1, C. Fano1, F. Bonadies1, E. Sarno1, A. Venturi1, P. De Vecchi1, S. Menuzzo1, S. Gallimberti1, D. Grosso1

Author affiliations

  • 1 Centro Coordinamento "infermieri Di Ricerca", Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 2 Direzione Professioni Sanitarie, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
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Resources

Abstract 5777

Background

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.

Methods

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 periodScreening phase (-14 to -1)Every 4 weeks (until at first tumor assessment)
Informed Consent FormX
Inclusion/Exclusion CriteriaX
HOC Questionnaire CreatedX
DLQI QuestionnaireXX
BrochureaX
Interview with nursebXX

Results

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.

Conclusions

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.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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