Clinical trial · 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
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (36)
- measure
- Number of Participants Categorized According to the Napping Habits for All Participants at Baseline
- timeFrame
- Baseline
- description
- In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
- measure
- Number of Participants Categorized According to the Napping Habits for All Participants at Week 12
- timeFrame
- Week 12
- description
- In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
- measure
- Number of Participants Categorized According to the Napping Habits for All Participants at Week 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available