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)

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).

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma

Detailed Description

Prospective, multicentre, observational study in patients with metastatic renal cell carcinoma (mRCC) receiving a tyrosine kinase inhibitor as first-line treatment according to routine clinical practice, designed to evaluate the incidence of fatigue and hand-foot syndrome in order to determine how these affect the baseline characteristics of the patient and his/her disease (age, gender, baseline status, tumour histology, etc.) and the patient's lifestyle as such side effects develop.

An exploratory analysis will be performed of measures that clinicians may adopt to improve patients' quality of life with regards to daytime naps, medication administration time, off-treatment periods, dose reductions and treatment breaks.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06006
    • H. Universitario Infanta Cristina
  • Barcelona, Spain, 08035
    • Hospital Vall de Hebron
  • Ciudad Real, Spain, 13005
    • Hospital Universitario Ciudad Real
  • Córdoba, Spain, 14004
    • H. Reina Sofía de Cordoba
  • Girona, Spain, 17007
    • ICO Girona (Hospital Dr.Josep Trueta)
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • León, Spain, 24071
    • Complejo Hospitalario de León
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa / Servicio de Oncología Médica
  • Ourense, Spain, 32005
    • Complejo Hospitalario Ourense. Hospital Santa María Nai
  • Oviedo, Spain, 33011
    • Hospital General De Asturias
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Santa Cruz de Tenerife, Spain, 38320
    • Hospital Universitario Canarias
  • Tarragona, Spain, 43003
    • Hospital de Sant Pau i Santa Tecla
  • Toledo, Spain, 45071
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46011
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • H Clínico Zaragoza
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Hospital Arquitecto Marcide de Ferrol
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Hospital Asil de Granollers
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli
  • Bizkaia
    • Usansolo, Bizkaia, Spain, 48960
      • Hospital Galdakano
  • Ciudad REAL
    • Alcazar de San Juan, Ciudad REAL, Spain, 13600
      • Complejo Hospitalario La Mancha Centro
  • Mallorca
    • Palma, Mallorca, Spain, 07120
      • Hospital Universitari Son Espases
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitario Sant Joan de Reus / Servicio de Oncología Médica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A population of 100 patients aged 18 years or over and diagnosed with metastatic renal cell carcinoma who are to start first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice is to be studied

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Categorized According to the Napping Habits for All Participants at 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.	Baseline
Number of Participants Categorized According to the Napping Habits for All Participants at 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.	Week 12
Number of Participants Categorized According to the Napping Habits for All Participants at 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.	Week 24
Number of Participants Categorized According to the Napping Habits for All Participants at 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.	Week 36
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at 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.	Baseline
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at 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.	Week 12
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at 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.	Week 24
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at 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.	Week 36
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.	Baseline
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.	Week 6
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.	Week 12
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.	Week 18
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24	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.	Week 24
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30	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.	Week 30
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36	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.	Week 36
Number of Participants Classified According to Time of Taking Treatment at Week 1	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 1
Number of Participants Classified According to Time of Taking Treatment at Week 6	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 6
Number of Participants Classified According to Time of Taking Treatment at Week 12	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 12
Number of Participants Classified According to Time of Taking Treatment at Week 18	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 18
Number of Participants Classified According to Time of Taking Treatment at Week 24	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 24
Number of Participants Classified According to Time of Taking Treatment at Week 30	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 30
Number of Participants Classified According to Time of Taking Treatment at Week 36	In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.	Week 36
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up	In this outcome measure, number of participants were classified according to the number of changes to dose that is (i.e). 0, 1 or 2 occurred per treatment cycle during 9 months of follow-up.	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	In this outcome measure, number of participants were classified according to the number of interruptions to dose i.e. 0, 1, 2, 3 or 4 occurred in each treatment cycle during 9 months follow-up.	During 9 months
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1)	Best response was recorded from start of treatment with TKI until best complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) was achieved. RECIST v1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions [TLs]) or non-target lesions (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; c) DP: >=20% increase in sum of diameter of all TLs, taking as reference the smallest sum on study (including baseline measurement), sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion; d) SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for PD referring smallest sum diameter. Participant whose best response was not determined were classified as "Undetermined".	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	In this outcome measure, the mean duration of treatment was calculated and reported below.	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	TTF was defined as the time from the start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause. Participants who did not had the event were censored on the date of their final follow-up. Per RECIST 1.1, tumour progression: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of >=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.	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	In this outcome measure, number of participants were classified according to number of treatment cycles received.	From start of treatment till end of treatment (approximately maximum up to 3.8 years)
Progression-Free Survival (PFS)	PFS was defined as the time from the start of treatment with a TKI to tumour progression or death for any reason. Participants who, did not had the event were censored on the date of their final follow-up. Per RECIST v1.1, tumour progression: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of >=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.	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)	ORR was defined as the percentage of participants who achieved CR or PR. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.	From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years)
Duration of Response (DOR)	In participants who achieved CR or PR, DOR was defined as the duration from the documentation date of CR or PR to the first day when DP was observed. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions must have reduction in short axis to <10 mm; normalization of tumor marker level for non-target lesions; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) DP: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement), sum must also demonstrate an absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion.	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	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with fatigue event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.	During 9 months
Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with hand foot syndrome event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.	During 9 months
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 12 are reported.	Week 12
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 24 are reported.	Week 24
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 36 are reported.	Week 36

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: TFS Trial Form Support

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2016
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: metastatic renal cell carcinoma
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Carcinoma, Renal Cell; Carcinoma; Hand-Foot Syndrome
• Other Study ID Numbers: A6181218; TROYA (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.