Prevalence, severity and origin of lymphedema among women five years after treatment for breast cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23930

Enrollment

266

Registered

2008-05-06

Start date

2008-07-01

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

Prevalentie Lymfoedeem Borstkanker Chronisch Prevalence Lymphedema Breast cancer Chronic

Interventions

Status research Absence or presence of lumpectomy, ablation, microdochectomy, sentinel node procedure, axillary lymph node dissection, radiotherapy (chest, armpit), chemotherapy, hormonal therapy an

Eligibility

Inclusion criteria

Inclusion criteria: Wemon who visited the “mammapoli” for the first time in the period from January 2001 till December 2002 and were diagnosed with breast cancer.

Exclusion criteria

Exclusion criteria: If the breast cancer reoccurs, the patient will be excluded from further research. If the patient is death, she will be exluded.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactM.F. Meyenfeldt

University Hospital Maastricht, Departement of Surgery, P.O. Box 5800

mf.vonmeyenfeldt@ah.unimaas.nl+31 (0)43 3877478

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)