|- candidate number||25451|
|- NTR Number||NTR6104|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-okt-2016|
|- Secondary IDs||CCMO NL57754.041.16 METC 16/450|
|- Public Title||PAM study|
|- Scientific Title||Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: the PAM study|
|- ACRONYM||PAM study |
|- hypothesis||We hypothesize that exercise training positively affects cognitive functioning measured by standard neuropsychological tests, especially learning and memory. Furthermore, we hypothesize that exercise training will result in the following changes on brain MRI:|
- increased brain volume, including the hippocampus (the hippocampus is especially involved in memory and learning)
- increased connectivity of white matter (especially connections with the hippocampus)
- increased brain perfusion
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Cognitive problems|
|- Inclusion criteria||cancer patients adjuvantly treated with chemotherapy with or without endocrine therapy, 2-4 years after cancer diagnosis, 30-75 years of age, no indication of relapse or metastases, exercise °‹ 150 min/week,
self-reported cognitive problems, lower than expected performance on neuropsychological testing, mastering the Dutch language and willing to be randomly assigned to one of the two study arms.
|- Exclusion criteria||We will exclude patients with known neurological conditions and/or diseases that affect cognition (e.g. dementia, MS, TBI), disorders that might impede exercise participation, contra indications for MR imaging, treated for breast cancer in both breasts; and patients switching from Tamoxifen to aromatase inhibitors during the study period or four months before|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2016|
|- planned closingdate||1-sep-2019|
|- Target number of participants||180|
|- Interventions||A 6-month exercise program consisting of aerobic and strength exercise supervised by a physiotherapist (2 hrs/w) and Nordic or Power Walking (2 hrs/w). Controls will be asked to retain their usual physical activity level. |
|- Primary outcome||Primary outcome parameters are: cognitive functioning (the total recall score of the HVLT-R as our primary outcome measure) and self-reported cognitive complaints (MDASI-MM module, 2 symptom severity questions on memory and attention and 6 symptom interference items).
|- Secondary outcome||Secondary parameters include overall cognitive functioning measured by standard neuropsychological tests, brain structure and function (3 Tesla brain MRI), anthropometrics, physical fitness, QOL, fatigue, anxiety and depressive symptoms, and work performance.
|- Timepoints||Basline, 6 months|
|- Trial web site||www.juliuscenter.com/pam|
|- CONTACT FOR PUBLIC QUERIES||PhD Evelyn Monninkhof|
|- CONTACT for SCIENTIFIC QUERIES||PhD Evelyn Monninkhof|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Increased survival of breast cancer patients has put more emphasis on studying long-term consequences of treatment and quality of life (QOL). A recently established long-term consequence of breast cancer treatment is cognitive decline. Up to 60% of breast cancer patients treated with chemotherapy may be confronted with cognitive problems as assessed with neuropsychological tests, which can persist up to 10 years after treatment. Cognitive problems reduce QOL, daily functioning and work performance. Therefore, interventions to preserve or enhance cognition are urgently needed. A promising non-pharmacological option for cognitive problems in breast cancer patients is physical exercise. In older persons and patients with neurological disease evidence accumulates of positive effects of exercise on cognition. Therefore, we will investigate the effects of exercise in breast cancer patients with cognitive problems. Further, since imaging studies have documented brain changes associated with chemotherapy, we will also assess the effects of exercise on brain structure and function. These imaging data may provide insights into the neurobiological mechanisms underlying cognitive recovery in these patients. Furthermore, we are specifically interested in the effects of exercise on brain structure and function in these patients.
Study design: Randomised controlled trial, with a waiting list control group
Study population: Breast cancer patients adjuvantly treated with chemotherapy (with or without endocrine therapy), 2-4 years after diagnosis, aged 30-75 years, no indication of relapse or metastases and self-reported cognitive problems confirmed by neuropsychological tests.
Intervention: A 6-month exercise program consisting of aerobic and strength exercise supervised by a physiotherapist (2 hrs/w) and Nordic or Power walking (2 hrs/w). Controls will be asked to retain their usual physical activity level.
Main study parameters/endpoints:
Primary outcome parameters are: cognitive functioning (the total recall score of the HVLT-R as our primary outcome measure) and self-reported cognitive complaints (MDASI-MM module, 2 symptom severity questions on memory and attention and 6 symptom interference items).
Secondary parameters include overall cognitive functioning measured by standard neuropsychological tests, brain structure and function (3 Tesla brain MRI), anthropometrics, physical fitness, QOL, fatigue, anxiety and depressive symptoms, and work performance.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Study participation takes time, especially for patients in the intervention group.
Patients will visit the UMC Utrecht for measurements at baseline and after the intervention period. Each visit will take 3 hours.
Patients in the intervention group are invited to participate in a 6 month exercise program of 4 hours weekly (2 hours at a physiotherapy centre and 2 hours Nordic or Power walking). Burden of travelling to the training facilities will be reduced by offering the exercise program at physiotherapist centers nearby the patientsí home.
- Injuries due to exercise can occur, to minimize the risk the intensity of the exercise program will be gradually increased during the study and supervised by a physiotherapist.
- One of the measurements at the UMC Utrecht is a brain MRI. The scan time of the MRI takes 45325 min.
- Every patient will be asked to wear an accelerometer for 2two times one weeks.
- During the blood draws, a haematoma can occur after blood sampling.
- Incidental findings can arise in the different measurements (e.g. maximal exercise testing; brain MRI), which will be reported to participants.
- We expect that the exercise program will have a beneficial effect on the patientsí health status.
|- Main changes (audit trail)|
|- RECORD||24-okt-2016 - 25-nov-2016|
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