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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants Categorized According to the Napping Habits for All Participants at Baseline
Timeframe: Baseline
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12
Timeframe: Week 12
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24
Timeframe: Week 24
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36
Timeframe: Week 36
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline
Timeframe: Baseline
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12
Timeframe: Week 12
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24
Timeframe: Week 24
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36
Timeframe: Week 36
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline
Timeframe: Baseline
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6
Timeframe: Week 6
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Timeframe: Week 12
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18
Timeframe: Week 18
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
Timeframe: Week 24
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30
Timeframe: Week 30
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36
Timeframe: Week 36
Number of Participants Classified According to Time of Taking Treatment at Week 1
Timeframe: Week 1
Number of Participants Classified According to Time of Taking Treatment at Week 6
Timeframe: Week 6
Number of Participants Classified According to Time of Taking Treatment at Week 12
Timeframe: Week 12
Number of Participants Classified According to Time of Taking Treatment at Week 18
Timeframe: Week 18
Number of Participants Classified According to Time of Taking Treatment at Week 24
Timeframe: Week 24
Number of Participants Classified According to Time of Taking Treatment at Week 30
Timeframe: Week 30
Number of Participants Classified According to Time of Taking Treatment at Week 36
Timeframe: Week 36
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up
Timeframe: During 9 months
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
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)
Mean Duration of Treatment
Timeframe: From start of treatment till end of treatment (approximately maximum up to 3.8 years)
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)
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)
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)
Objective Response Rate (ORR)
Timeframe: From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years)
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)
Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeframe: During 9 months
Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeframe: During 9 months
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12
Timeframe: Week 12
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24
Timeframe: Week 24
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36
Timeframe: Week 36