The primary goal is investigating the number of women that have lymphedema five years after the treatment for breast cancer. In the describing part of this study, the focus will be on the correlation between lymphedema and 1) surgical treatment, 2)…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Musculoskeletal and connective tissue disorders NEC
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end goal is to determine the presence of lymphedema among female
patients five years after the treatment for breast cancer. The water
replacement technique is used to measure the arm volume. When the difference
between the two arms is bigger than 150ml or 200ml, lymphedema is diagnosed.
Secondary outcome
Status research
Outcome parameters are: absence or presence of lumpectomy, ablation,
microdochectomy, sentinel node procedure, axillary lymph node dissection,
radiotherapy (chest, armpit), chemotherapy, hormonal therapy and TNM
classification.
Questionnaires and conversation
The scores of the EORTC QLQ-BR23 en EORTC QLQ-C30 questionnaires will be noted
as an outcome. (For questionnaires see appendix 1 and 2)
Outcome parameters are: absence or presence of risk factors and of therapy for
lymph edema and this result will be used as an outcome. (For questionnaires see
appendix 3 and 4)
Physical examination
As an outcome the absence or presence of overweight, sensibility, mobility and
strength will be noted.
The stage of the lymphedema will be determined as defined by the Society For
Lymphology. Results will be processed in a database.
When there is lymphedema present, the preference location will be determined by
measuring the circumference. The outcome is presence of lymphedema on a
specific part of the arm.
Background summary
This scientific research is important, because the survival rate of patients
with breast cancer has increased, thanks to very early diagnostics and new
treatment possibilities. Due to the higher survival rate, patients have more
problems with the postoperative complications of the treatment for breast
cancer. One of the most common complications is lymphedema. This has a strong
negative effect on the quality of life. Therefore it is important that the
cause, risk factors, the severity of lymphedema, disabilities and the effect of
the treatment for lymphedema are investigated. Goal of this investigation is
preventing lymphedema and making therapy possible in an early stage. In this
way complications can be reduced to a minimum or even prevented
Study objective
The primary goal is investigating the number of women that have lymphedema five
years after the treatment for breast cancer.
In the describing part of this study, the focus will be on the correlation
between lymphedema and 1) surgical treatment, 2) additional therapies, 3) risk
factors for lymphedema. Besides these first four goals attention will be paid
to 4) the degree and the severity of edema, 5) the functional consequences and
6) earlier treatment and its result on the consequences of the treatment for
breast cancer.
Study design
The study design is a retro- and prospective cohort study. The prevalence,
severity and nature of lymphedema will be determined among women five years
after treatment for breast cancer.
Study burden and risks
The participating patients are in no extra risk of complications caused by the
study. The patients will come once for one hour to the AZM for a conversation,
to fill out questionnaires and a physical examination. No invasive examination
will take place. During the physical check up the arms are inspected and
palpated and the range of motion, arm volume, sense of touch, strength are
measured. Questionnaire subjects are: quality of life after (breast) cancer,
risk factors for lymphedema and therapy for complications after the treatment
for breast cancer. The participants will receive the result of the test. When
there are complications, an advice for therapy will be given. Because of the
low risk that patients have by participating in this study, a dispensation of
insurance has been asked for.
P. Debeyelaan 25
6229 HX Maastricht
Nederland
P. Debeyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with breast cancer who visited the ''mammapoli'' of the AZM for the first time in the period from September 2001 till September 2002, irrespective of the treatment that they got.
Exclusion criteria
Patients get excluded from the resurge if they are death and if they have a recurrence of the local tumor. They have to give their informed consent otherwise they also get excluded.
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 |
|---|---|
| Other | 3182 |
| CCMO | NL21458.068.08 |