N/A
N=111
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
Metastatic Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02789137 ↗Enrolled (actual)
111
Serious AEs
25.2%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Categorized According to the Napping Habits for All Participants at Baseline — 22; 33; 31 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized According to the Napping Habits for All Participants at Baseline |
22; 33; 31 | — |
| PRIMARY Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 |
18; 24; 21 | — |
| PRIMARY Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 |
18; 15; 12 | — |
| PRIMARY Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 |
16; 16; 9 | — |
| PRIMARY Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline |
10; 0; 7; 34; 14; 22 | — |
| PRIMARY Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 |
14; 6; 10; 9; 12; 11 | — |
| PRIMARY Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 |
13; 5; 7; 10; 5; 7 | — |
| PRIMARY Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 |
4; 1; 3; 19; 5; 9 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline |
40.0 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6 |
34.7 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 |
36.4 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18 |
35.3 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 |
36.3 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30 |
34.9 | — |
| PRIMARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36 |
35.5 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 1 |
39; 31; 15; 1 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 6 |
19; 13; 7; 43 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 12 |
21; 10; 10; 22 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 18 |
19; 9; 6; 24 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 24 |
12; 8; 12; 13 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 30 |
12; 9; 10; 14 | — |
| PRIMARY Number of Participants Classified According to Time of Taking Treatment at Week 36 |
10; 8; 7; 16 | — |
| PRIMARY Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up |
82; 19; 0; 69; 25; 0 | — |
| PRIMARY Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up |
76; 25; 0; 0; 0; 73 | — |
| PRIMARY Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) |
0; 42; 29; 28; 12 | — |
| PRIMARY Mean Duration of Treatment |
8.9 | — |
| PRIMARY Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy |
6.9 | — |
| PRIMARY Number of Participants Categorized According to Number of Treatment Cycles Received |
2; 10; 21; 8; 12; 3 | — |
| PRIMARY Progression-Free Survival (PFS) |
9.3 | — |
| PRIMARY Objective Response Rate (ORR) |
37.8 | — |
| PRIMARY Duration of Response (DOR) |
11.8 | — |
| PRIMARY Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
6; 0 | — |
| PRIMARY Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
30; 2 | — |
| PRIMARY Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 |
11; 7; 1 | — |
| PRIMARY Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 |
11; 2; 1 | — |
| PRIMARY Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 |
8; 1; 1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02789137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.