The aim of this study is to evaluate investigate whether BCRL will improve in patients with BCRL undergoing DIEP-flap BR combined with an inguinal lymph node transplant have statistically significant improvement of their BCRL (primary objective),…
ID
Source
Brief title
Condition
- Spleen, lymphatic and reticuloendothelial system disorders
- Haematological and lymphoid tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degree of lymphedema at affected arm measured by Inverse water volumetry and
difference in mobility and ROMrange of motion .:
Secondary outcome
Patient reported satisfaction and Quality of Life as measured by multiple
questionnaires:
- Range of motion of the shoulder joint in the following directions: abduction,
ante flexion, retro flexion, medial and lateral rotation
- Lymph-ICF questionnaire [Appendix C]
- The Breast-Q reconstruction Module [Appendix D]
Background summary
Although the prevalence of breast cancer related lymphedema (BCRL) has
decreased over the years, BCRL remains a very debilitating, devastating
complication which is hard to treat. At this moment, most patients with
lymphedema are treated conservatively. Surgical interventions for lymphedema
are divided in reductive and reconstructive treatment. For reconstructive
treatment as lympho-venous anastomosis and or free lymph node transplantations
are performed. In this study we want willto evaluate if combining a standard
DIEP-flap breast reconstruction (BR) combined with an inguinal lymph node
transplant will lead to an improvement of the BCRL
Study objective
The aim of this study is to evaluate investigate whether BCRL will improve in
patients with BCRL undergoing DIEP-flap BR combined with an inguinal lymph node
transplant have statistically significant improvement of their BCRL (primary
objective), and Quality of life (secondary objective) compared to the patients
group receiving a solemnly DIEP-flap BR without an inguinal lymph node
transplant. Furthermore, this study will investigate the Quality of life
(secondary objective) in these two patient groups.
Study design
The study is a multicenter, double blinded randomized control trial in patients
with BCRL and an indication/ and wish for BR. One group will receive DIEP-flap
BR with an inguinal lymph node transplant and the other group will receive
DIEP-flap BR without an inguinal lymph node transplant.
Intervention
DIEP-flap BR with or without an inguinal lymph node transplant.
Study burden and risks
The burden of study participants is relatively low. No additional visits to the
UMCG or ECL are required. The visits at both the UMCG and ECL are standard in
women with BCRL undergoing DIEP-flap BR. The administration of questionnaires
however are not standard of care. These need to be filled out at four moments
and take approximately 30 minutes of the patients time. Since we will
administrate the questionnaires through a link sent by e-mail, the
administration is rather simple and patients can chose their moment for filling
out the questionnaires. As for the lymph node transplant, no additional
wounds/scars are made during the harvest of the lymph node. The harvest of one
lymph node has been found to be a safe procedure. However, there are some case
reports of iatrogenic lower limb lymphedema after inguinal lymph node
harvesting. In order to minimalize this risk, we will use indocyanine green
(ICG) to safely select a lymph node for transplantation. The safety profile of
ICG is widely known and chances of side-effects and/or toxicity are minimal
(ICG can cause (mild) side-effects in less than 0.0001% of the patients).
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
• All patients with complaints of lymphedema with an indication for secondary BR
• Persistent volume excess of more than 5-10% of the affected arm (arm at side
of mastectomy) in comparison to the contralateral arm measured by inverse water
volumetry with pitting oedema
• Persistent volume excess of the affected arm, patients are in maintenance
phase of treatment for BCRL
• Good patient coherence and willingness to wear therapeutic garments
• Operability
Exclusion criteria
• Recurrent malignancy
• Lipoedema of the upper extremetiesextremities
• Lymphedema of the lower extremetieextremity(s)
• Patients with untreated lymphedema
• Patients with bilateral upper arm lymphedema
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 | NL71102.042.20 |
| Other | TBA |