To determine the difference in change over time of cognitive function and brain magnetic resonance imaging (MRI) measurements between breast cancer survivors and cancer-free individuals.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Structural brain disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The difference in change over time of cognitive function between breast
cancer survivors and cancer-free individuals
2. The difference in change over time of brain MRI measurements between breast
cancer survivors and cancer-free individuals
Secondary outcome
1. The difference in change of subjective memory complaints between breast
cancer survivors and cancer-free individuals
2. The predictive value of cognitive function at the first assessment for
cognitive function at follow-up measurement among breast cancer survivors
3. The predictive value of subjective memory complaints at the first assessment
predict cognitive function at follow-up measurement among breast cancer
survivors
4. The difference in risk of dementia between breast cancer survivors and
cancer-free individuals.
5. The difference in change of inflammatory markers between breast cancer
survivors and cancer-free individuals.
6. The relation between cognitive function and inflammatory markers in breast
cancer survivors and cancer-free individuals.
Background summary
Non-central nervous system cancer patients frequently report cognitive problems
that persist well into the survivorship period. Several studies have shown that
cognitive function is affected by cancer and cancer treatment, but the course
of cognitive decline is less well understood. Two hypotheses regarding the
trajectory of cognitive decline have been proposed, i.e., 1) phase shift
hypothesis, with impaired cognitive function shortly after cancer treatment,
followed by a trajectory of cognitive decline that parallels the cognitive
trajectory of cancer-free individuals and 2) accelerated aging hypothesis, with
the trajectory of cognitive decline among cancer patients having a steeper
slope, compared to the cognitive trajectory of cancer-free individuals.
Study objective
To determine the difference in change over time of cognitive function and brain
magnetic resonance imaging (MRI) measurements between breast cancer survivors
and cancer-free individuals.
Study design
Cohort study.
Study burden and risks
Participants will be tested once. The examinations are similar to those
performed in 2008 and 2009, and will last 135 minutes. They include
measurements of weight, length, and blood pressure, a blood sample draw, an
interview, neuropsychological tests, and brain MRI. The patient has to lie
still in the MRI scan which can be inconvenient. The scan produces noise, which
is effectively reduced by using earplugs and headphones. When standard safety
rules are applied, no risks exist for the patient. Ample experience with
patient populations and participants from the Rotterdam Study have indicated
that this procedure is feasible and is not too burdensome. Knowledge about the
trajectory of cognitive decline may aid in prevention and treatment of
cognitive impairment in cancer patients.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Breast cancer survivors who participated in our previous study
(NL18761.031.07).
Inclusion criteria in our previous study were:
female
treatment with adjuvant CMF chemotherapy for breast cancer between 1975 and 1995
age between 50 and 80 years
sufficient proficiency in Dutch language
Exclusion criteria
No exclusion criteria will be applied for the current study. For our previous
study the following exclusion criteria were applied:
use of endocrine therapy
contra-indications for MRI scan
tumor relapse
metastases
second primary tumor
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72396.031.20 |