Hodgkin's Disease and Chemotherapy Before 40 Years
ConditionHodgkin Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorLille Catholic University
About this trial
A few studies have focused on other solid cancers (colorectal, prostate). On the other hand, the study of cognitive impairment in Hodgkin's disease remains less developed, and structural and functional post-therapy MRI studies have never been carried out. The impact of cognitive impairment on Hodgkin's 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 Hodgkin's 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient with newly diagnosed Hodgkin's disease
With intention to treat with chemotherapy +/- radiotherapy
Aged between 18 and 40 years
Fluency in French
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Morphological and functional magnetic resonance imaging (MRI)
Other interventionPatients will undergo 3 morphological and functional MRI scans (during rest and activity) on the 3T MRI scanner at St Philibert Hospital (Lille, France) at 0 (M0), 6 (M6) and 12 (M12) months. The controls will perform a single functional MRI on the 3T MRI.
Neuropsychological assessment
Other intervention3 neuropsychological assessments will be carried out at M0, M6 and M12, by the same neuropsychologist for all patients included. Controls will undergo the same neuropsychological assessments, but only once.
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Patients with Hodgkin's diseaseOther 2 interventions
Group B: Controls without Hodgkin's diseaseOther 2 interventions
Trial outcomes
Primary outcomes
1
Computerized Speed Cognitive Test (CSCT)
The CSCT will be used to evaluate the impact of Chemotherapy +/- radiotherapy treatment on the attentional abilities of HD cases, immediately after the end of treatment, and at a distance from this treatment. The CSCT score is calculated as follows: The patient has 90 seconds to orally state the correspondence of numbers (from 1 to 9) to 9 different symbols (matched according to a correspondence standard). The number of correct answers is measured (maximum score of 120).
Time frame
12 monthsSecondary outcomes
1
Brief Visual-spatial Memory Test-Revised
Recall performance is recorded for each of the immediate recall trials (Trial 1, Trail 2, and Trial 3) and for the delayed recall trial (Delayed Recall). The recall scores are combined to form three additional summary measures of learning and memory. Recognition Hits and False Alarms are recorded during the delayed recognition task. Recognition Hits are calculated as the number of correct "YES" responses to target items, and Recognition False Alarms are calculated as the number of incorrect "yes" responses to nontarget items.
Time frame
12 months2
D2-R
The d2-R tests the candidate's ability to discriminate details in a short space of time, while maintaining concentration. Candidates must locate and cross out target characters (d with 2 lines) from a large number of distractors in less than 20 seconds for each series.the candidate's index reflects his or her performance compared to people in his or her age group. A European sample of over 2,100 subjects aged between 18 and 55, representative of the population, is used as a reference.
Time frame
12 months3
Trail Making test
The Trail Making Test (TMT) is a freely available, timed, neuropsychological test that involves visual scanning and working memory. The TMT has two parts; the TMT-A (rote memory) and TMT-B (executive functioning).85 In each test the participant is asked to draw a line between 24 consecutive circles that are randomly arranged on a page. The TMT-A uses all numbers, whereas the TMT-B alternates numbers and letters, requiring the patient to switch between numbers and letters in consecutive order. The TMT is scored by how long it takes to complete the test. The time includes correction of errors prompted by the examiner. If the person cannot complete the test in 5 minutes, the test is discontinued. An average score for TMT-A is 29 seconds and a deficient score is greater than 78 seconds. For TMT-B, an average score is 75 seconds and a deficient score is greater than 273 seconds.
Time frame
12 months4
Functional Assessment of Cancer Therapy- Cognitive Function (FACT-Cog)
The FACT-Cog is a 37-item self-response measure to assess cognitive concerns of cancer patients, consisting of four subscales. The patient indicates how often the situation occurred during the last 7 days, on a 5-point Likert scale ("0 = Never" to "4 = Several times a day").
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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