Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer

Terminated

• Conditions: Metastatic Kidney Cancer

• Registration Number: NCT01336231
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patient (e) Age (e) over 18 years
• Kidney cancer metastatic or locally advanced
• Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
• Proposed treatment in first line or second line
• Brain imaging not finding brain metastases
• Having signed the informed consent of study participation
• The patient may have received prior anti-angiogenic

Exclusion Criteria

• Cancer of the kidney other than primitive
• Previous history of cancer other than kidney cancer in complete remission for less than 5 years
• Patients under 18 years
• Patients whose treatment is associated with chemotherapy
• disorders of cognitive functions to existing treatment delivery
• Pathology psychiatric evolutionary
• Refusal of participation
• Patient unable to respond to cognitive tests
• Drug use
• Heavy drinking (WHO criteria)
• History of stroke
• History of head trauma
• Brain metastases known
• MMS below normal compared to existing standards for age and socio-cultural

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of fatigue, memory problems and attentional	up to 12 months after treatment	Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.

Secondary Outcome Measures

Name	Time	Method
Impact of anxiety and depression	up to 12 months after treatment	Assessing the impact of anxiety and depression at the waning of treatment
Effects of different antiangiogenic agents	up to 12 months after treatment	Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used
List of symptoms	up to 12 months after treatment	Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.
Impact on the sexuality	up to 12 months after treatment	sess the impact on the sexuality of patients with the waning of treatment
Parameters of quality of life	up to 12 months after treatment	Studying the different parameters of quality of life and their evolution over time.
disorders of cognitive functions	up to 12 months after treatment	Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.
biological disturbances	up to 9 months after treatment	Search for biological disturbances may be related to fatigue and cognitive disorders.

Trial Locations

Locations (5)

Hôpital Georges Pompidou; 🇫🇷 Paris, Ile de France, France

CHU; 🇫🇷 Strasbourg, France

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Henri Becquerel; 🇫🇷 Rouen, Seine Maritime, France