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

Completed

• Conditions: Digestive System Diseases; Pulmonary Disease; Prostatic Disease; Bladder Disease; Lymphoma; Ovarian Diseases

• Registration Number: NCT00210249
• Lead Sponsor: Institut Bergonié

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

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-09
• Study Completion: 2008-09
• Results First Submitted: 2021-11-09
• Results First Submitted QC: 2021-11-09
• Status Verified: 2022-01
• Results First Posted: 2022-01-12
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participant Deaths	6 months after inclusion	Number of participant deaths observed during the course of the study

Trial Locations

Locations (18)

Centre Hospitalier Universitaire d'Agen; 🇫🇷 Agen, France

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, 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

Clinique Francheville; 🇫🇷 Perigueux, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

Centre Hospitalier Universitaire de Bayonne; 🇫🇷 Bayonne, France

Centre de radiothérapie d'Agen; 🇫🇷 Agen, France

Centre Hospitalier Universitaire de Dax; 🇫🇷 Dax, France

Clinique Esquirol Saint Hilaire; 🇫🇷 Agen, France

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

Clinique Saint Etienne du Pays Basque; 🇫🇷 Bayonne, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Maison de Santé Protestante Bagatelle; 🇫🇷 Talence, France

Centre Hospitalier Universitaire de Perigueux; 🇫🇷 Perigueux, France

Centre Hospitalier Universitaire de Villeneuve sur Lot; 🇫🇷 Villeneuve sur Lot, France