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
CompletedResults postedLast updated 5 November 2021
What this trial tests
trial in Metastatic Renal Cell Carcinoma in 111 participants. Completed in 20 October 2020.
18 and older, any sex, with Metastatic Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Categorized According to the Napping Habits for All Participants at BaselinePrimary· Baseline
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.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
22
Tyrosine Kinase Inhibitor
33
Tyrosine Kinase Inhibitor
31
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12Primary· Week 12
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.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
18
Tyrosine Kinase Inhibitor
24
Tyrosine Kinase Inhibitor
21
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24Primary· Week 24
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.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
18
Tyrosine Kinase Inhibitor
15
Tyrosine Kinase Inhibitor
12
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36Primary· Week 36
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.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
16
Tyrosine Kinase Inhibitor
16
Tyrosine Kinase Inhibitor
9
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at BaselinePrimary· Baseline
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Fatigue: Yes
Group
Value
95% CI
Tyrosine Kinase Inhibitor
10
Tyrosine Kinase Inhibitor
0
Tyrosine Kinase Inhibitor
7
Fatigue: No
Group
Value
95% CI
Tyrosine Kinase Inhibitor
34
Tyrosine Kinase Inhibitor
14
Tyrosine Kinase Inhibitor
22
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12Primary· Week 12
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Fatigue: Yes
Group
Value
95% CI
Tyrosine Kinase Inhibitor
14
Tyrosine Kinase Inhibitor
6
Tyrosine Kinase Inhibitor
10
Fatigue: No
Group
Value
95% CI
Tyrosine Kinase Inhibitor
9
Tyrosine Kinase Inhibitor
12
Tyrosine Kinase Inhibitor
11
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24Primary· Week 24
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Fatigue: Yes
Group
Value
95% CI
Tyrosine Kinase Inhibitor
13
Tyrosine Kinase Inhibitor
5
Tyrosine Kinase Inhibitor
7
Fatigue: No
Group
Value
95% CI
Tyrosine Kinase Inhibitor
10
Tyrosine Kinase Inhibitor
5
Tyrosine Kinase Inhibitor
7
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36Primary· Week 36
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Fatigue: Yes
Group
Value
95% CI
Tyrosine Kinase Inhibitor
4
Tyrosine Kinase Inhibitor
1
Tyrosine Kinase Inhibitor
3
Fatigue: No
Group
Value
95% CI
Tyrosine Kinase Inhibitor
19
Tyrosine Kinase Inhibitor
5
Tyrosine Kinase Inhibitor
9
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at BaselinePrimary· Baseline
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
40.0
± 9.6
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6Primary· Week 6
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
34.7
± 11.4
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12Primary· Week 12
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
36.4
± 10.6
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18Primary· Week 18
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Group
Value
95% CI
Tyrosine Kinase Inhibitor
35.3
± 11.5
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of treatment till end of treatment (approximately maximum up to 3.8 years).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 5 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02789137.