GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance

Breast Cancer Clinical Trial

— GERABEL  

Official title:

GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02994914
• Other study ID #: 2016-0902
• Secondary ID: 2016-A01469-42
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: June 26, 2020

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Woman more than 70 years old,
• Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.

Exclusion Criteria:

• Man,
• Patient with metastatic cancer,
• Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
• Patient under protection of justice or unable to give consent.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Emile Roux	Le Puy-en-Velay
France	Groupement Hospitalier Portes de Provence	Montelimar
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest en Jarez

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Centre Antoine Lacassagne, Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 6
Secondary	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.	Month 6
Secondary	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.	Month 6
Secondary	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.	Month 6
Secondary	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.	Month 6
Secondary	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.	Month 6
Secondary	Correlation between tolerance and the number of concomitant treatments	Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.	Month 6
Secondary	Correlation between tolerance and the nature of concomitant treatments	Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.	Month 6
Secondary	Correlation between tolerance and the supportive cares	Correlation will potentially be established between patient general tolerance and the supportive cares performed.	Month 6