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Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer - Physical Activity & Memory (PAM) study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50463
Enrollment
180
Registered
2016-10-19
Start date
2016-12-10
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

cognitive function breast cancer / cognitive function

Interventions

A 6-month exercise programme 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

Sponsors

Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the study are: breast cancer patients adjuvantly treated with chemotherapy plus or minus 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

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, patients with breast cancer in both breasts, contra indications for MR imaging (see Appendix 2 Protocol); 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), 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 with standard neuropsychological tests, brain structure and function (3 Tesla brain MRI), anthropometrics, physical fitness, QOL, fatigue, anxiety and depressive symptoms, and work performance.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)