Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06116929
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-10-31
Brief Title:
Hodgkins Disease and Chemotherapy Before 40 Years
Sponsor:
Lille Catholic University
Organization:
Lille Catholic University
Study Overview
Official Title:
Functional and Cognitive Assessment of Patients With Hodgkins Disease Undergoing Chemotherapy Before 40 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FunC-AHOD
Brief Summary:
A few studies have focused on other solid cancers colorectal prostate On the other hand the study of cognitive impairment in Hodgkins disease remains less developed and structural and functional post-therapy MRI studies have never been carried out The impact of cognitive impairment on Hodgkins disease is rarely if ever assessed in routine clinical practice despite the fact that it is truly disabling in 16 to 30 of patients Cognitive impairment can persist long after diagnosis and treatment A recent study examining cognitive functioning in patients an average of 13 years after treatment found that disorders persisted in 52 of cases with attentional working memory and dysexecutive planning difficulties These disorders have a significant impact on the daily and professional lives of these young often working patients Their rapid development and persistence after treatment can therefore represent a real limiting factor impacting both professional integration and quality of life Finally the current state of knowledge does not allow us to dissociate cognitive disorders from emotional disorders and fatigue which represent a major patient complaint A better definition of the nature pathophysiology and specificity of these disorders would therefore enable us to take better account of their repercussions social professional and on quality of life and provide better care in terms of cognitive remediation or psychological support
A prospective longitudinal multicenter case-control interventional study in which cases are patients with Hodgkins disease HD treated with CT - radiotherapy and controls are healthy participants will be conducted The aim is to study the prevalence and nature of treatment-induced cognitive impairment and its correlation with emotional comorbidities as well as structural and functional brain disorders on MRI The patient will thus be his or her own witness the reference state being that at the time of diagnosis before any treatment The fact that this state has not already been altered by the disease itself will be verify thanks to comparison with controls
A prospective longitudinal multicenter case-control interventional study in which cases are patients with Hodgkins disease HD treated with CT - radiotherapy and controls are healthy participants will be conducted The aim is to study the prevalence and nature of treatment-induced cognitive impairment and its correlation with emotional comorbidities as well as structural and functional brain disorders on MRI The patient will thus be his or her own witness the reference state being that at the time of diagnosis before any treatment The fact that this state has not already been altered by the disease itself will be verify thanks to comparison with controls
Detailed Description:
Hodgkins disease is a neoplasia of lymphoid tissue characterized by the characteristic presence of Reed Sternberg cells This disease is preferentially affecting young patients under the age of 40 It is the leading cause of solid cancer in adolescents and young adults At the time of diagnosis positron emission tomography PET scan is used to determine the stage of the disease The Ann Arbor classification differentiates between localized I-II and disseminated III-IV stages At St Vincent de Paul Hospital Lille France 60-70 of diagnoses are performed at a localized stage versus 30-40 at a disseminated stage
Treatment is based on chemotherapy alone disseminated forms or a combination of chemotherapy and radiotherapy localized forms The average duration of treatment is around 5 months for localized forms and between 6 and 7 months for disseminated forms The prognosis is favorable with a sustained complete remission rate of up to 85 in patients of all stages The aim of treatment for these patients is therefore to achieve complete remission while reducing medium- and long-term side-effects which could improve their quality of life
Recently treatment strategies have evolved with de-escalation of chemotherapy intensity and strategies guided by early response to Positron emission tomography PET scan have become the norm in order to significantly reduce the risk of long-term side effects
The onset of cognitive and mood disorders in patients undergoing neoplastic treatment particularly after chemotherapy is a frequent and disabling complication Numerous studies have identified the occurrence of subjective and objective attentional memory and executive disorders However these studies are often limited by their small size the variability of populations their heterogeneous design and the variability of neuropsychological measures and criteria for defining a cognitive deficit Furthermore the majority of studies have focused on patients treated with chemotherapy CT for breast neoplasia through neuropsychological assessment and exploration by structural and functional medical imaging Thus the onset of cognitive disorders more of a dysexecutive nature in these patients has been clearly identified both early at the end of treatment and over the long term
Moreover the social occupational and quality-of-life repercussions of these disorders have only recently been explored However initial results point to a positive correlation between subjective perception of cognitive functioning and quality of life Nevertheless the probably multifactorial etiology of these disorders remains unclear A recent review of the literature clarifies the factors predisposing to the development of these cognitive disorders Factors such as age and genetic polymorphisms in apolipoprotein E catechol-O-methyltransferase and Brain-derived neurotrophic factor BDNF may predispose individuals to a higher risk of cognitive disorders In addition changes in brain morphology reduced grey matter volume and changes in brain connectivity could be at the root of these disorders
In these studies magnetic resonance imaging MRI identified the presence of frontal and posterior parietal gray matter volume loss in these patients MRI also provides information on the structural and functional functioning of brain networks For example changes in the integrity of substance bundles have been identified using the diffusion tensor technique In functional MRI fMRI BOLD signal numerous disturbances have been identified hypoactivation of the prefrontal cortex and parietal lobes during activation of the executive control network hypoactivation of the prefrontal cortex and hippocampi during tasks involving working memory alteration of the dorsal attentional network and the default mode network
In addition one study suggests the presence of pre-treatment network alterations in patients with breast neoplasia At pathophysiological level animal models suggest the involvement of alterations in neurogenesis mitochondrial dysfunction or cerebral cytokine response
Treatment is based on chemotherapy alone disseminated forms or a combination of chemotherapy and radiotherapy localized forms The average duration of treatment is around 5 months for localized forms and between 6 and 7 months for disseminated forms The prognosis is favorable with a sustained complete remission rate of up to 85 in patients of all stages The aim of treatment for these patients is therefore to achieve complete remission while reducing medium- and long-term side-effects which could improve their quality of life
Recently treatment strategies have evolved with de-escalation of chemotherapy intensity and strategies guided by early response to Positron emission tomography PET scan have become the norm in order to significantly reduce the risk of long-term side effects
The onset of cognitive and mood disorders in patients undergoing neoplastic treatment particularly after chemotherapy is a frequent and disabling complication Numerous studies have identified the occurrence of subjective and objective attentional memory and executive disorders However these studies are often limited by their small size the variability of populations their heterogeneous design and the variability of neuropsychological measures and criteria for defining a cognitive deficit Furthermore the majority of studies have focused on patients treated with chemotherapy CT for breast neoplasia through neuropsychological assessment and exploration by structural and functional medical imaging Thus the onset of cognitive disorders more of a dysexecutive nature in these patients has been clearly identified both early at the end of treatment and over the long term
Moreover the social occupational and quality-of-life repercussions of these disorders have only recently been explored However initial results point to a positive correlation between subjective perception of cognitive functioning and quality of life Nevertheless the probably multifactorial etiology of these disorders remains unclear A recent review of the literature clarifies the factors predisposing to the development of these cognitive disorders Factors such as age and genetic polymorphisms in apolipoprotein E catechol-O-methyltransferase and Brain-derived neurotrophic factor BDNF may predispose individuals to a higher risk of cognitive disorders In addition changes in brain morphology reduced grey matter volume and changes in brain connectivity could be at the root of these disorders
In these studies magnetic resonance imaging MRI identified the presence of frontal and posterior parietal gray matter volume loss in these patients MRI also provides information on the structural and functional functioning of brain networks For example changes in the integrity of substance bundles have been identified using the diffusion tensor technique In functional MRI fMRI BOLD signal numerous disturbances have been identified hypoactivation of the prefrontal cortex and parietal lobes during activation of the executive control network hypoactivation of the prefrontal cortex and hippocampi during tasks involving working memory alteration of the dorsal attentional network and the default mode network
In addition one study suggests the presence of pre-treatment network alterations in patients with breast neoplasia At pathophysiological level animal models suggest the involvement of alterations in neurogenesis mitochondrial dysfunction or cerebral cytokine response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None