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

NCT ID: NCT02789137

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-22
• Study Completion Date: 2020-10-20

Brief 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.

Detailed 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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

metastatic renal cell carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor 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 a legal representative.
• Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.

Exclusion Criteria

• Patients who are not candidates for first-line treatment with a tyrosine kinase inhibitor.
• 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 cytochrome CYP3A4.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TFS Trial Form Support

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Hospital Arquitecto Marcide de Ferrol

Ferrol, A Coruña, Spain

Hospital Asil de Granollers

Granollers, Barcelona, Spain

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Hospital Galdakano

Usansolo, Bizkaia, Spain

Complejo Hospitalario la Mancha Centro

Alcázar de San Juan, Ciudad REAL, Spain

Hospital Universitari Son Espases

Palma, Mallorca, Spain

Hospital Universitario Sant Joan de Reus / Servicio de Oncología Médica

Reus, Tarragona, Spain

H. Universitario Infanta Cristina

Badajoz, , Spain

Hospital Vall de Hebrón

Barcelona, , Spain

Hospital Universitario Ciudad Real

Ciudad Real, , Spain

H. Reina Sofía de Cordoba

Córdoba, , Spain

ICO Girona (Hospital Dr.Josep Trueta)

Girona, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Complejo Hospitalario de León

León, , Spain

Hospital Universitario La Princesa / Servicio de Oncología Médica

Madrid, , Spain

Complejo Hospitalario Ourense. Hospital Santa María Nai

Ourense, , Spain

Hospital General de Asturias

Oviedo, , Spain

Complejo Hospitalario de Navarra

Pamplona, , Spain

Hospital Universitario Canarias

Santa Cruz de Tenerife, , Spain

Hospital de Sant Pau i Santa Tecla

Tarragona, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

H Clínico Zaragoza

Zaragoza, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A6181218

To obtain contact information for a study center near you, click here.

Other Identifiers

TROYA

Identifier Type: OTHER

Identifier Source: secondary_id

A6181218

Identifier Type: -

Identifier Source: org_study_id