Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol
Abstract Background New generation hormone-therapies (NGHT) targeting the androgen signalling pathway are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive function has never been evaluated whereas cognitiv...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-08-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-017-3534-8 |
| _version_ | 1819212780461359104 |
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| author | Marie Lange Heidi Laviec Hélène Castel Natacha Heutte Alexandra Leconte Isabelle Léger Bénédicte Giffard Aurélie Capel Martine Dubois Bénédicte Clarisse Elodie Coquan Frédéric Di Fiore Sophie Gouérant Philippe Bartélémy Laure Pierard Karim Fizazi Florence Joly |
| author_facet | Marie Lange Heidi Laviec Hélène Castel Natacha Heutte Alexandra Leconte Isabelle Léger Bénédicte Giffard Aurélie Capel Martine Dubois Bénédicte Clarisse Elodie Coquan Frédéric Di Fiore Sophie Gouérant Philippe Bartélémy Laure Pierard Karim Fizazi Florence Joly |
| author_sort | Marie Lange |
| collection | DOAJ |
| description | Abstract Background New generation hormone-therapies (NGHT) targeting the androgen signalling pathway are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive function has never been evaluated whereas cognitive impairment may have an impact on the autonomy and the treatment adherence. The aim of this study is to prospectively assess the incidence of cognitive impairment in elderly men after treatment by NGHT for a metastatic CRPCa. Methods/design The Cog-Pro study is a multicentre longitudinal study including CRPCa patients ≥70 years old treated with NGHT (n = 134), control metastatic prostate cancer patients without castration resistance treated with first generation androgen deprivation therapy (n = 55), and healthy participants (n = 33), matched on age and education. Cognitive, geriatric and quality of life assessment and biological tests will be performed at baseline, 3, 6 and 12 months after start of the treatment (inclusion time). The primary endpoint is the proportion of elderly patients receiving a NGHT who will experience a decline in cognitive performances within 3 months after study enrollment. Secondary endpoints concern: autonomy, quality of life, anxiety, depression, cognitive reserve, adherence to hormone-therapy, comparison of the cognitive impact of 2 different NGHT (abiraterone acetate and enzalutamide), impact of co-morbidities and biological assessments. Discussion Evaluating, understanding and analyzing the incidence, severity of cognitive impairments and their impact on quality of life, autonomy and adherence in this group of patients with advanced disease is a challenge. This study should help to improve cancer care of elderly patients and secure the use of oral treatments as the risk of non-observance does exist. Our results will provide up-to date information for patients and caregivers on impact of these treatments on cognitive function in order to help the physicians in the choice of the treatment. Trial registration NCT02907372, registered: July 26, 2016. |
| first_indexed | 2024-12-23T06:48:24Z |
| format | Article |
| id | doaj.art-70d0efd87a8f4f56adc20c6097d8397e |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-23T06:48:24Z |
| publishDate | 2017-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-70d0efd87a8f4f56adc20c6097d8397e2022-12-21T17:56:30ZengBMCBMC Cancer1471-24072017-08-011711810.1186/s12885-017-3534-8Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocolMarie Lange0Heidi Laviec1Hélène Castel2Natacha Heutte3Alexandra Leconte4Isabelle Léger5Bénédicte Giffard6Aurélie Capel7Martine Dubois8Bénédicte Clarisse9Elodie Coquan10Frédéric Di Fiore11Sophie Gouérant12Philippe Bartélémy13Laure Pierard14Karim Fizazi15Florence Joly16INSERM, U1086 ANTICIPE, Normandie University, UNICAENMedical Oncology Department, Centre François BaclesseCancer and Cognition Platform, Ligue Nationale Contre le CancerINSERM, U1086 ANTICIPE, Normandie University, UNICAENClinical Research Department, Centre François BaclesseINSERM, U1086 ANTICIPE, Normandie University, UNICAENCancer and Cognition Platform, Ligue Nationale Contre le CancerClinical Research Department, Centre François BaclesseCancer and Cognition Platform, Ligue Nationale Contre le CancerClinical Research Department, Centre François BaclesseClinical Research Department, Centre François BaclesseMedical Oncology Department, Centre Henri-BecquerelMedical Oncology Department, Centre Henri-BecquerelMedical Oncology and Hematology Department, Hôpitaux Universitaires de StrasbourgMedical Oncology and Hematology Department, Hôpitaux Universitaires de StrasbourgMedical Oncology Department, Gustave RoussyINSERM, U1086 ANTICIPE, Normandie University, UNICAENAbstract Background New generation hormone-therapies (NGHT) targeting the androgen signalling pathway are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive function has never been evaluated whereas cognitive impairment may have an impact on the autonomy and the treatment adherence. The aim of this study is to prospectively assess the incidence of cognitive impairment in elderly men after treatment by NGHT for a metastatic CRPCa. Methods/design The Cog-Pro study is a multicentre longitudinal study including CRPCa patients ≥70 years old treated with NGHT (n = 134), control metastatic prostate cancer patients without castration resistance treated with first generation androgen deprivation therapy (n = 55), and healthy participants (n = 33), matched on age and education. Cognitive, geriatric and quality of life assessment and biological tests will be performed at baseline, 3, 6 and 12 months after start of the treatment (inclusion time). The primary endpoint is the proportion of elderly patients receiving a NGHT who will experience a decline in cognitive performances within 3 months after study enrollment. Secondary endpoints concern: autonomy, quality of life, anxiety, depression, cognitive reserve, adherence to hormone-therapy, comparison of the cognitive impact of 2 different NGHT (abiraterone acetate and enzalutamide), impact of co-morbidities and biological assessments. Discussion Evaluating, understanding and analyzing the incidence, severity of cognitive impairments and their impact on quality of life, autonomy and adherence in this group of patients with advanced disease is a challenge. This study should help to improve cancer care of elderly patients and secure the use of oral treatments as the risk of non-observance does exist. Our results will provide up-to date information for patients and caregivers on impact of these treatments on cognitive function in order to help the physicians in the choice of the treatment. Trial registration NCT02907372, registered: July 26, 2016.http://link.springer.com/article/10.1186/s12885-017-3534-8Cognitive impairmentsAgeingProstate cancerHormone therapyAdherenceQuality of life |
| spellingShingle | Marie Lange Heidi Laviec Hélène Castel Natacha Heutte Alexandra Leconte Isabelle Léger Bénédicte Giffard Aurélie Capel Martine Dubois Bénédicte Clarisse Elodie Coquan Frédéric Di Fiore Sophie Gouérant Philippe Bartélémy Laure Pierard Karim Fizazi Florence Joly Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol BMC Cancer Cognitive impairments Ageing Prostate cancer Hormone therapy Adherence Quality of life |
| title | Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol |
| title_full | Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol |
| title_fullStr | Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol |
| title_full_unstemmed | Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol |
| title_short | Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol |
| title_sort | impact of new generation hormone therapy on cognitive function in elderly patients treated for a metastatic prostate cancer cog pro trial protocol |
| topic | Cognitive impairments Ageing Prostate cancer Hormone therapy Adherence Quality of life |
| url | http://link.springer.com/article/10.1186/s12885-017-3534-8 |
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