An interventional study of Onco Geriatric Evaluation in Breast Cancer, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 3 sites in France. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.
Breast cancer is the most frequent cancer for elderly women and represents the first mortality cause for them. Breast cancer incidence increases for elderly women and will become a major public health problem in the next years.
The principal therapeutic solution is the partial mastectomy associated to radiotherapy. However, the radiotherapy scheme and its role are debated for elderly patients. Hypo fractionated radiotherapy could be considered as an advantageous option.
The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are major cons. Thereby, for elderly patients, the selection of patients who will benefit from a shorter treatment could be really difficult. It would be interesting to define an objective scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays, onco geriatric evaluations are used to decide some treatment's decision, but no study compared different orientated radiotherapy schemes.
The present study proposes an onco geriatric evaluation leading to a score according to seven tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an adapted radiotherapy scheme.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 241 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
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Exclusion Criteria:
According to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Other: Onco Geriatric Evaluation
According to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Other: Onco Geriatric Evaluation
According to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Other: Onco Geriatric Evaluation
Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.
Measure of the tolerance
Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.
Time frame: Month 6
Tolerance
Specific tolerance will be evaluated by the number of radiation-induced toxicities (Common Terminology Criteria for Adverse Events 4.4) of I, II, III, and IV grades.
Time frame: Month 6
Quality of Life Questionnaire
Quality of life will be assessed with the difference between the Quality of Life Questionnaire 30 of the European Organisation for Research and Treatment of Cancer (EORTC) score obtained before the radiotherapy and 6 months after the end of the radiation therapy.
Time frame: Month 6
Radiotherapy compliance
Compliance is considered as "bad" if the treatment plan is interrupted for at least one day (for medical reason). Compliance is considered as "correct" in the other cases.
Time frame: Month 6
Correlation between tolerance and distance from the therapeutic center
Correlation will potentially be established between patient general tolerance and the distance between home and radio therapeutic center.
Time frame: Month 6
Correlation between tolerance and way of transport
Correlation will potentially be established between patient general tolerance and the way of transport used by the patient to go to the therapeutic center.
Time frame: Month 6
Correlation between tolerance and the number of concomitant treatments
Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.
Time frame: Month 6
Correlation between tolerance and the nature of concomitant treatments
Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.
Time frame: Month 6
Correlation between tolerance and the supportive cares
Correlation will potentially be established between patient general tolerance and the supportive cares performed.
Time frame: Month 6
Plan to share: No
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne