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PAM study

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: the PAM study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21029
Enrollment
180
Registered
2016-10-24
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, cognitive problems, borstkanker, cognitieve problemen

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 phy

Sponsors

University Medical Center Utrecht (UMCU)
Lead Sponsor

Eligibility

Inclusion criteria

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 ¡Ü 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactEvelyn Monninkhof

University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care, Stratenum 6.131, P.O. Box 85500

e.monninkhof@umcutrecht.nl+31 (0)30 2509379

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)