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Spots Global Cancer Trial Database for Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment

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Trial Identification

Brief Title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment

Official Title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

Study ID: NCT00210249

Interventions

Study Description

Brief Summary: Incidence of cancer in 75+ years old is 16,500 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 (ADL;IADL), 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 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA\< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL\<6, 29% get up and go\>20seconds, 27% ADL\>1, 34% PS\<1), 28% of them had altered cognitive functions (MMS\<24), 29% were depressive (GDS-15\>6), 25% thought they had poor quality of life (QLQ-C30\<4). Protocol will be closed in September 2005.

Detailed Description:

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre de radiothérapie d'Agen, Agen, , France

Centre Hospitalier Universitaire d'Agen, Agen, , France

Clinique Esquirol Saint Hilaire, Agen, , France

Centre Hospitalier Universitaire de Bayonne, Bayonne, , France

Centre Hospitalier de la Côte Basque, Bayonne, , France

Clinique Saint Etienne du Pays Basque, Bayonne, , France

Clinique Tivoli, Bordeaux, , France

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, , France

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest, Bordeaux, , France

Centre Hospitalier Universitaire de Dax, Dax, , France

Hopital Sub-Urbain du Bouscat, Le Bouscat, , France

Hôpital Robert Boulin, Libourne, , France

Centre Hospitalier Universitaire de Mont de Marsan, Mont de Marsan, , France

Centre Hospitalier Universitaire de Pau, Pau, , France

Centre Hospitalier Universitaire de Perigueux, Perigueux, , France

Clinique Francheville, Perigueux, , France

Maison de Santé Protestante Bagatelle, Talence, , France

Centre Hospitalier Universitaire de Villeneuve sur Lot, Villeneuve sur Lot, , France

Contact Details

Name: Pierre SOUBEYRAN, MD, PhD

Affiliation: Institut Bergonié

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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