NCT01336231
Terminated
Not Applicable
Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study
Centre Francois Baclesse5 sites in 1 country82 target enrollmentOctober 2008
ConditionsMetastatic Kidney Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Kidney Cancer
- Sponsor
- Centre Francois Baclesse
- Enrollment
- 82
- Locations
- 5
- Primary Endpoint
- Impact of fatigue, memory problems and attentional
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer
Investigators
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
- •Heavy drinking (WHO criteria)
- •History of stroke
Outcomes
Primary Outcomes
Impact of fatigue, memory problems and attentional
Time Frame: 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 Outcomes
- Impact of anxiety and depression(up to 12 months after treatment)
- Effects of different antiangiogenic agents(up to 12 months after treatment)
- List of symptoms(up to 12 months after treatment)
- Impact on the sexuality(up to 12 months after treatment)
- Parameters of quality of life(up to 12 months after treatment)
- disorders of cognitive functions(up to 12 months after treatment)
- biological disturbances(up to 9 months after treatment)
Study Sites (5)
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