Clinical trial NCT02789137: 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
Official title: PROSPECTIVE, MULTICENTRE, OBSERVATIONAL 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 (TROYA STUDY).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: metastatic renal cell carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: TFS Trial Form Support
First posted: 2016-06-02
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of 100 patients aged 18 years or over and diagnosed with metastatic renal cell carcinoma who are to start first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice is to be studied

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.

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.

Primary outcomes:
measure: Number of Participants Categorized According to the Napping Habits for All Participants at Baseline
timeFrame: Baseline
measure: Number of Participants Categorized According to the Napping Habits for All Participants at Week 12
timeFrame: Week 12
measure: Number of Participants Categorized According to the Napping Habits for All Participants at Week 24
timeFrame: Week 24
measure: Number of Participants Categorized According to the Napping Habits for All Participants at Week 36
timeFrame: Week 36
measure: Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline
timeFrame: Baseline
measure: Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12
timeFrame: Week 12
measure: Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24
timeFrame: Week 24
measure: Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36
timeFrame: Week 36
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline
timeFrame: Baseline
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6
timeFrame: Week 6
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
timeFrame: Week 12
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18
timeFrame: Week 18
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
timeFrame: Week 24
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30
timeFrame: Week 30
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36
timeFrame: Week 36
measure: Number of Participants Classified According to Time of Taking Treatment at Week 1
timeFrame: Week 1
measure: Number of Participants Classified According to Time of Taking Treatment at Week 6
timeFrame: Week 6
measure: Number of Participants Classified According to Time of Taking Treatment at Week 12
timeFrame: Week 12
measure: Number of Participants Classified According to Time of Taking Treatment at Week 18
timeFrame: Week 18
measure: Number of Participants Classified According to Time of Taking Treatment at Week 24
timeFrame: Week 24
measure: Number of Participants Classified According to Time of Taking Treatment at Week 30
timeFrame: Week 30
measure: Number of Participants Classified According to Time of Taking Treatment at Week 36
timeFrame: Week 36
measure: Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up
timeFrame: During 9 months
measure: Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up
timeFrame: During 9 months
measure: Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1)
timeFrame: From start of treatment with TKI until first documented best response of CR, PR, SD or DP (approximately maximum up to 3.8 years)
measure: Mean Duration of Treatment
timeFrame: From start of treatment till end of treatment (approximately maximum up to 3.8 years)
measure: Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy
timeFrame: From start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause or till follow-up in case of no event (approximately maximum up to 3.8 years)
measure: Number of Participants Categorized According to Number of Treatment Cycles Received
timeFrame: From start of treatment till end of treatment (approximately maximum up to 3.8 years)
measure: Progression-Free Survival (PFS)
timeFrame: From start of treatment with a TKI to tumour progression or death for any reason or till follow-up in case of no event (approximately maximum up to 3.8 years)
measure: Objective Response Rate (ORR)
timeFrame: From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years)
measure: Duration of Response (DOR)
timeFrame: From day of documented CR or PR to the first day that DP was observed (approximately maximum up to 3.8 years)
measure: Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: During 9 months
measure: Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: During 9 months
measure: Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12
timeFrame: Week 12
measure: Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24
timeFrame: Week 24
measure: Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36
timeFrame: Week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide de Ferrol
state: A Coruña
city: Granollers
country: Spain
facility: Hospital Asil de Granollers
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Usansolo
country: Spain
facility: Hospital Galdakano
state: Bizkaia
city: Alcazar de San Juan
country: Spain
facility: Complejo Hospitalario la Mancha Centro
state: Ciudad REAL
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Mallorca
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus / Servicio de Oncología Médica
state: Tarragona
city: Badajoz
country: Spain
facility: H. Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Vall de Hebrón
city: Ciudad Real
country: Spain
facility: Hospital Universitario Ciudad Real
city: Córdoba
country: Spain
facility: H. Reina Sofía de Cordoba
city: Girona
country: Spain
facility: ICO Girona (Hospital Dr.Josep Trueta)
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Complejo Hospitalario de León
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa / Servicio de Oncología Médica
city: Ourense
country: Spain
facility: Complejo Hospitalario Ourense. Hospital Santa María Nai
city: Oviedo
country: Spain
facility: Hospital General de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Canarias
city: Tarragona
country: Spain
facility: Hospital de Sant Pau i Santa Tecla
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Zaragoza
country: Spain
facility: H Clínico Zaragoza
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: