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Trial record 144 of 159 for:    Recruiting, Not yet recruiting, Available Studies | "Adverse Drug Events" OR "Adverse Drug Reactions" OR "Drug Related Side Effects"

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)

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ClinicalTrials.gov Identifier: NCT02789137
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease
Metastatic Renal Cell Carcinoma

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
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).
Actual Study Start Date : December 22, 2016
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Foot Health




Primary Outcome Measures :
  1. Fatigue-related quality of life with validated 13-item FACIT-Fatigue scale for patients with metastatic renal cancer in Spanish [ Time Frame: 9 months ]
    Fatigue-related quality of life of patients receiving a tyrosine kinase inhibitor evaluated using the validated 13-item FACIT-Fatigue scale for patients with metastatic renal cancer in Spanish


Secondary Outcome Measures :
  1. Quality of life in patients with palmar-plantar erythrodysaesthesia according to version 4 of the CTCAE [ Time Frame: 9 months ]
    Quality of life in patients with palmar-plantar erythrodysaesthesia

  2. Assessment of adverse effects according to version 4 of the CTCAE [ Time Frame: 9 months ]
    To assess the following adverse effects according to version 4 of the CTCAE (Common Terminology Criteria for Adverse Events): any grade of fatigue and hand-foot syndrome (HFS).

  3. Time to Treatment Failure (TTF) [ Time Frame: 9 months ]
    Time to Treatment Failure (TTF), defined as the time from the start of treatment with a tyrosine kinase inhibitor to tumour progression, treatment discontinuation for any reason or death from any cause.

  4. Progression-Free Survival (PFS) (median) [ Time Frame: 9 months ]
    Progression-Free Survival (PFS) (median): time from the start of treatment with a tyrosine kinase inhibitor to tumour progression or death from any cause.

  5. Objective Response Rate according to RECIST version 1.1. [ Time Frame: 9 months ]
    Objective Response Rate according to RECIST version 1.1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789137


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Spain
Hospital Arquitecto Marcide de Ferrol Recruiting
Ferrol, A Coruña, Spain, 15405
Hospital Asil de Granollers Recruiting
Granollers, Barcelona, Spain, 08402
Hospital Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Hospital Galdakano Recruiting
Usansolo, Bizkaia, Spain, 48960
Complejo Hospitalario la Mancha Centro Recruiting
Alcazar de San Juan, Ciudad REAL, Spain, 13600
Hospital Universitari Son Espases Recruiting
Palma, Mallorca, Spain, 07120
H. Universitario Infanta Cristina Recruiting
Badajoz, Spain, 06006
Hospital Vall de Hebrón Recruiting
Barcelona, Spain, 08035
Hospital Universitario Ciudad Real Recruiting
Ciudad Real, Spain, 13005
H. Reina Sofía de Cordoba Recruiting
Córdoba, Spain, 14004
Hospital de Cabueñes Not yet recruiting
Gijón, Spain, 33394
ICO Girona (Hospital Dr.Josep Trueta) Recruiting
Girona, Spain, 17007
Hospital Universitario de Guadalajara Not yet recruiting
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaén Recruiting
Jaén, Spain, 23007
Complejo Hospitalario de León Recruiting
León, Spain, 24071
Complejo Hospitalario Ourense. Hospital Santa María Nai Recruiting
Ourense, Spain, 32005
Hospital General de Asturias Not yet recruiting
Oviedo, Spain, 33011
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain, 31008
Hospital Universitario Canarias Not yet recruiting
Santa Cruz de Tenerife, Spain, 38320
Hospital de Sant Pau i Santa Tecla Recruiting
Tarragona, Spain, 43003
Hospital Virgen de la Salud Recruiting
Toledo, Spain, 45071
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46011
H Clínico Zaragoza Recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Pfizer
TFS Trial Form Support
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02789137     History of Changes
Other Study ID Numbers: A6181218
TROYA ( Other Identifier: Alias Study Number )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Pfizer:
metastatic renal cell carcinoma

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Carcinoma
Fatigue
Carcinoma, Renal Cell
Hand-Foot Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Chemically-Induced Disorders