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N/A N=364

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

Lymphoma · Digestive System Diseases · Ovarian Diseases · Pulmonary Disease · Prostatic Disease

Enrolled (actual)
364
Serious AEs
Results posted
Jan 2022
Primary outcome: Primary: Number of Participant Deaths — 56 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Older Adult · 70+ yrs
Sex
All
Sponsor
Institut Bergonié
Primary completion
Sep 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participant Deaths
56

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 20seconds, 27% ADL>1, 34% PS 6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.

Eligibility Criteria

Inclusion criteria

  • Age ≥ 70 years
  • First line of chemotherapy
  • Cancer previously mentioned
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00210249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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