CompletedNot Applicable

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

Spain111 participantsStarted 2016-12-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT02789137

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-10-20

Results submitted2021-10-06

View on ClinicalTrials.gov More Metastatic Renal Cell Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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