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

Metastatic Kidney Cancer Clinical Trial

— COG-ANGIO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01336231
• Other study ID #: COG-ANGIO
• Status: Terminated
• Phase: N/A
• First received: April 12, 2011
• Last updated: July 20, 2016
• Start date: October 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2016
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Fatigue
• Kidney Neoplasms
• Metastatic Kidney Cancer

Locations

Country	Name	City	State
France	Centre François BACLESSE	Caen	Calvados
France	Hôpital Georges Pompidou	Paris	Ile de France
France	Centre Henri Becquerel	Rouen	Seine Maritime
France	CHU	Rouen	Seine Maritime
France	CHU	Strasbourg
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of fatigue, memory problems and attentional	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.	up to 12 months after treatment	No
Secondary	Parameters of quality of life	Studying the different parameters of quality of life and their evolution over time.	up to 12 months after treatment	No
Secondary	disorders of cognitive functions	Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.	up to 12 months after treatment	No
Secondary	biological disturbances	Search for biological disturbances may be related to fatigue and cognitive disorders.	up to 9 months after treatment	No
Secondary	Impact of anxiety and depression	Assessing the impact of anxiety and depression at the waning of treatment	up to 12 months after treatment	No
Secondary	List of symptoms	Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.	up to 12 months after treatment	No
Secondary	Impact on the sexuality	sess the impact on the sexuality of patients with the waning of treatment	up to 12 months after treatment	No
Secondary	Effects of different antiangiogenic agents	Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used	up to 12 months after treatment	No