Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment

Last updated: October 6, 2021
Sponsor: Pfizer
Overall Status: Completed

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT02789137
A6181218
TROYA
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or cure such side effects that affect patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator'sopinion, are candidates for starting first-line treatment with a tyrosine kinaseinhibitor according to routine clinical practice.
  • Patients who have no contraindications to the treatment.
  • Baseline ECOG ≤ 2.
  • Patients who are able to give informed consent on their own without the need for alegal representative.
  • Committed patients who are able to complete the quality of life questionnaires andpatient diary on their own without the need for a legal representative.

Exclusion

Exclusion Criteria:

  • Patients who are not candidates for first-line treatment with a tyrosine kinaseinhibitor.
  • Patients who are receiving the treatment as second-line or subsequent therapy.
  • Untreated hypothyroidism.
  • Untreated severe anaemia.
  • Pregnancy or breast-feeding.
  • Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months.
  • Severe hepatic impairment.
  • Concomitant use of potent inhibitors or inducers that interact with hepatic cytochromeCYP3A4.

Study Design

Total Participants: 111
Study Start date:
December 22, 2016
Estimated Completion Date:
October 20, 2020

Study Description

Prospective, multicentre, observational study in patients with metastatic renal cell carcinoma (mRCC) receiving a tyrosine kinase inhibitor as first-line treatment according to routine clinical practice, designed to evaluate the incidence of fatigue and hand-foot syndrome in order to determine how these affect the baseline characteristics of the patient and his/her disease (age, gender, baseline status, tumour histology, etc.) and the patient's lifestyle as such side effects develop.

An exploratory analysis will be performed of measures that clinicians may adopt to improve patients' quality of life with regards to daytime naps, medication administration time, off-treatment periods, dose reductions and treatment breaks.

Connect with a study center

  • Hospital Arquitecto Marcide de Ferrol

    Ferrol, A Coruña 15405
    Spain

    Site Not Available

  • Hospital Asil de Granollers

    Granollers, Barcelona 08402
    Spain

    Site Not Available

  • Hospital Parc Taulí

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Galdakano

    Usansolo, Bizkaia 48960
    Spain

    Site Not Available

  • Complejo Hospitalario la Mancha Centro

    Alcazar de San Juan, Ciudad REAL 13600
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma, Mallorca 07120
    Spain

    Site Not Available

  • Hospital Universitario Sant Joan de Reus / Servicio de Oncología Médica

    Reus, Tarragona 43204
    Spain

    Site Not Available

  • H. Universitario Infanta Cristina

    Badajoz, 06006
    Spain

    Site Not Available

  • Hospital Vall de Hebrón

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Ciudad Real

    Ciudad Real, 13005
    Spain

    Site Not Available

  • H. Reina Sofía de Cordoba

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital de Cabueñes

    Gijón, 33394
    Spain

    Site Not Available

  • ICO Girona (Hospital Dr.Josep Trueta)

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Complejo Hospitalario de León

    León, 24071
    Spain

    Site Not Available

  • Hospital Universitario La Princesa / Servicio de Oncología Médica

    Madrid, 28006
    Spain

    Site Not Available

  • Complejo Hospitalario Ourense. Hospital Santa María Nai

    Ourense, 32005
    Spain

    Site Not Available

  • Hospital General de Asturias

    Oviedo, 33011
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario Canarias

    Santa Cruz de Tenerife, 38320
    Spain

    Site Not Available

  • Hospital de Sant Pau i Santa Tecla

    Tarragona, 43003
    Spain

    Site Not Available

  • Hospital Virgen de la Salud

    Toledo, 45071
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46011
    Spain

    Site Not Available

  • H Clínico Zaragoza

    Zaragoza, 50009
    Spain

    Site Not Available

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