The objective of the study is to determine the clinical relevance of sparing the lymfdrainage of the upper extremitiy by using the ARM-procedure in patients with breast cancer. The purpose of the continuation of the feasibility study is to create a…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Randomisation study:
Complications will be measured after 6, 12 and 24 months after the primary
procedure by a nurse practitioner/clinical investigator. The primary end-points
of the study are the presence of physical complains consisting of lymphoedema,
pain, numbness, loss of shoulder mobility.
Primary endpoints:
- Breast cancer related lymphoedema (BCRL)
- Paraesthesia/numbness
- Pain
- Loss of arm and shoulder mobility
Secundary endpoints:
- Quality of live
- Axillary recurrende rate
Feasibility (side-study):
- identification of ARM-nodes
- Involvement of the ARM-nodes in the metastatic proces
Secondary outcome
Randomisation study:
Secondary endpoints:
- Quality of life (QOL)
- Axillary recurrence rate
Disease free survival during the first 5-10 years will be documented during the
routinely control at the outpatient clinic.
Feasibility (side-study):
n.a.
Background summary
Axillary lymph node dissection (ALND) has potential negative side effects
associated with the procedure, these include: pain, numbness or paraesthesia,
swelling and arm mobility restriction.
A recently described technique makes it possible to discriminate the lymphatic
drainage pattern from the breast and the arm: axillary reverse mapping (ARM).
The concept of ARM is to map the drainage of the arm to determine the
anatomical variation in these lymphatics and thus have a roadmap for their
preservation. If arm lymph-edema is caused by cutting the axillary lymphatics,
identifying them before axillary lymph node dissection (ALND) is performed
would offer the possibility to preserve them.
A recently performed feasibility study in the Amphia hospital Breda, showed
that it was technically feasible to perform a ARM-procedure with Blue Patent
(visualization rate of 90.3%). During evaluation of the results, the patients
undergoing a ALND were divided in two groups: a group which underwent a ALND
secondary to a positive sentinel node procedure (SN+ group); and a group which
underwent a primary ALND based on a clinical positive axillary lymphnode proven
bij cytological puncture or patients with a contra-indication for a sentinel
node procedure (de CP-N+ group). After performing a ARM-procedure a standard
ALND was performed (a least level I-II) in all patients. The blue colored nodes
representing the arm-nodes were with separately removed and analyzed.
In the SN+group no arm-nodes showed metastasis. In the CP-N+ group the
arm-nodes of 22% of the patients showed metastatic involvement. Subgroup
analysis of the latter showed metastatic involvement of arm-nodes in 15.8% and
41.7% in patients which underwent neo-adjuvant chemotherapy and patients which
were scheduled to get adjuvant chemotherapy respectively.
We concluded that the ARM procedure is feasible with a high visualization rate
and that it is oncologic safe to safe the ARM-nodes in the SN+ group. Probably,
it is even safe to spare the arm-nodes in patients who underwent neo-adjuvant
chemotherapy, but these results need to be confirmed in further research.
These results are published in the European Journal of Surgical Oncology
(Gobardhan et al, 2012 Epub ahead of print)
Study objective
The objective of the study is to determine the clinical relevance of sparing
the lymfdrainage of the upper extremitiy by using the ARM-procedure in patients
with breast cancer.
The purpose of the continuation of the feasibility study is to create a larger
group of CP-N+ patients, eligble for sub-group analysis. This group consists of
patients treated with neo-adjuvant chemotherapy (NAC) and adjuvant
chemotherapy. The NAC group may be possible candidates for ARM-ALND as well
(see results feasibility study)
Study design
Double blind randomized controlled trial.
Intervention
ALND with or without sparing of the arm lymphatics and arm nodes.
Study burden and risks
The risk excists of an extra subcutaneous injection in de upper extremity with
blue patent. The risk of adverse events is limited, although a, temporary,
'blue tattoo' will exist.
The burden for the patient is that the regular outpatient clinic visits will
take some extra time due to the measurements and discussion of the
questionnaires. De volume-measurement will take probably 5 minutes per arm. The
questionnaires, completed by the patient, will be checked immediately.
Depending the local situation it may happen that patients will be asked for a
visit, beside the regular visit. In that situation a compensation for
travelling-expenses will be offered.
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
Inclusion criteria
Female mental competent patients of at least 18 years of age with the diagnosis invasive breast cancer with an indication for a complementary axillary lymph node dissection (ALND) based on a positive sentinel lymph node (SLN) are eligible for an ALND-ARM procedure. The indication for a complementary ALND will be made in a multidisciplinary team including an oncologic surgeon, medical oncologist, pathologist, radiologist and a radiotherapist.
Exclusion criteria
Exclusion criteria are: primary ALND based on a clinical positive axilla (proven by cytological punction), a contra-indication for sentinel lymph node biopsy (SLNB), a history of breast-cancer, adverse event during the previous SLNB, pregnancy.
Patients excluded for randomization between ALND and ALND-ARM will be possible candidates for the side study in which the feasibility of ARM (without sparing lymphatics and lymph nodes) is investigated.
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 | NL39202.015.12 |