Clinical trial NCT01336231: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer
Official title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Kidney Cancer
Keywords: quality of life
cognitive functions
antiangiogenic agents
kidney cancer
metastatic
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2011-04-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

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


Eligibility criteria: 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

Primary outcomes:
measure: Impact of fatigue, memory problems and attentional
timeFrame: up to 12 months after treatment
Secondary outcomes:
measure: Parameters of quality of life
timeFrame: up to 12 months after treatment
measure: disorders of cognitive functions
timeFrame: up to 12 months after treatment
measure: biological disturbances
timeFrame: up to 9 months after treatment
measure: Impact of anxiety and depression
timeFrame: up to 12 months after treatment
measure: List of symptoms
timeFrame: up to 12 months after treatment
measure: Impact on the sexuality
timeFrame: up to 12 months after treatment
measure: Effects of different antiangiogenic agents
timeFrame: up to 12 months after treatment
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Paris
country: France
facility: Hôpital Georges Pompidou
state: Ile de France
city: Rouen
country: France
facility: Centre Henri Becquerel
state: Seine Maritime
city: Rouen
country: France
facility: CHU
state: Seine Maritime
city: Strasbourg
country: France
facility: CHU
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY-LOBBEDEZ, PD
role: PRINCIPAL_INVESTIGATOR
References: