None listed
Conditions
Brief summary
This study aims to assess the effect of subcutaneous needle drainage of lymphoedema on quality of life in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a palliative diagnosis of cancer, and have lymphoedema which is deemed suitable for lymphoedema drainage. Study details All participants in this study will undergo subcutaneous needle drainage of lymphoedema. This involves the placement of small needles into the layer under the skin. They are attached to a special bag to capture the fluid. They will be in place for a number of days if still draining. Participants will be asked to complete a questionnaire before and twice after the procedure in order to determine any changes in quality of life. Participants will also be monitored for the occurrence of any complications. Sometimes, it is limited what can be offered to treat lymphoedema in late stages of cancer. This procedure provides relief for some patients.
Interventions
Needles inserted into lower limbs under sterile technique. Usually two needles in each affected limb according to where the lymphoedema is causing the most problems ie. if scrotal we place the needles higher on the leg. The palliative medicine specialist inserts the needles into the subcutaneous layer according to the protocol. The average duration of drainage is 5 days as an inpatient, and the needles stay in the entire time unless drainage stops or it becomes uncomfortable. The maximum dur
Needles inserted into lower limbs under sterile technique. Usually two needles in each affected limb according to where the lymphoedema is causing the most problems ie. if scrotal we place the needles higher on the leg. The palliative medicine specialist inserts the needles into the subcutaneous layer according to the protocol. The average duration of drainage is 5 days as an inpatient, and the needles stay in the entire time unless drainage stops or it becomes uncomfortable. The maximum duration for the needles remaining in situ is 6 days. The average length of the drainage was determined by the pilot study.
Sponsors
New Zealand Institute of Community Health Care
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have advanced malignancy and be suitable for palliative care. Patients must have lymphoedema suitable for lymphoedema drainage, i.e.: Lymphoedema is causing significant distress to patient, and contributing to a loss in their quality of life Lymphoedema no longer able to be controlled by use of compression stockings, massage or bandaging There is evidence of blockage in lymphatic flow proximal to the affected limb ( ie: fluid cannot be drained through normal flow pathways) Lymphoedema is soft and pitting (as opposed to hard, fibrotic and non pitting) Age >18 years. Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document. Patients must speak English
Exclusion criteria
Patients who have had chemotherapy within the last 30 days Patients with neutropenia (<1x10(9)L) and/or thrombocytopenia (<50x10(9)L) Patients who have active cellulitis Patients who are acutely unwell Patients who are immunosuppressed, anti-coagulated or have unexplained fever must be evaluated by medical professional before procedure
Outcome results
None listed