Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210249
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2005-09-13
Brief Title:
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment Geriatric Oncology Protocol in Aquitaine Country
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHRC2003
Brief Summary:
Incidence of cancer in 75 years old is 16500 new cases per year more than fifty percent of people with cancerThey are very few therapeutic trials dedicated Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life Consequently we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity loss of autonomy and survival We plan to accrue 360 patients diagnosed for cancer including digestive pulmonary prostate lymphoma bladder ovary cancer for whom first-line chemotherapy is planned Patients are initially classified according to usual methods of medical oncology practice into three groups patients who can receive standard treatment reduced standard treatment or treatment adapted to the frail condition Around Aquitaine we organised seven teams composed of one geriatrician and one nurse Two kind of teams were activated one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals Geriatric evaluation included test of cognitive functions MMS nutritional status MNA co-morbidity CIRS-G mobility Get up and Go activities ADLIADL quality of life QLQ-C30 depression GDS-15 and Lachs-Balducci screening Patients have four geriatric evaluations before treatment day 1 cycle 2 day 1 cycle 4 day 1 cycle 7 andor end of chemotherapy Since September 2002 177 patients have been included 112 have finished 473 have received four evaluations 161 died before the end of protocol 143 stopped because they were in progression and changed their treatment 116 met administrative problem that didnt allow all evaluations 71 declined after inclusion and 36 finished their treatment before The following results have been obtained before treatment 73 of these patients were at risk of undernutrition MNA 235 about 13 had one or more inability or a risk of falls 38 IADL6 29 get up and go20seconds 27 ADL1 34 PS1 28 of them had altered cognitive functions MMS24 29 were depressive GDS-156 25 thought they had poor quality of life QLQ-C304 Protocol will be closed in September 2005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC OncoG | OTHER | Institut Bergonié | None |