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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 on August 16, 2018

FOR MORE INFORMATION
Study Location
Hospital Arquitecto Marcide de Ferrol
Ferrol, A Coruña, 15405 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02789137
Pfizer
Recruiting
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

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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
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).
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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
9 Months
Not Provided
Non-Probability Sample
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
Metastatic Renal Cell Carcinoma
Not Provided
Not Provided
Not Provided
 
Recruiting
100
October 30, 2018
October 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Spain
 
 
NCT02789137
A6181218
TROYA ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
TFS Trial Form Support
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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