None listed
Conditions
Brief summary
The purpose of this study is to provide some preliminary data on the impact of different levels of compression on lymphoedema. Who is it for? You may be eligible for this study if you are over 18, have completed breast cancer therapy (except hormone treatments) at least 6 months ago and have been diagnosed with secondary arm lymphoedema. Study details Participants in this study will be randomised (by chance) into two groups. All participants will wear a compression garment for 12 hours a day for 6 months and will be a sleeve and gauntlet. You will be measured for these by a certified lymphoedema therapist. One group will wear a high compression garment, and the other will wear a low compression garment. Participants will have the garments checked after one week, two months and 4 months of wear; as well as have some scans, undergo some measurements and complete a questionnaire before and after the 6 month trial. It is hoped this research will provide important preliminary information as to what the optimal level of compression is for people with secondary arm lymphoedema.
Interventions
- Participants will be randomised to receive a low (15 - 25mmHg) or high (30 to 40mmHg) compression garment. All participants will wear the garments for 12 hours per day for 6 months and they will be provided 2 garments each. Participants will be measured for a Juzo sleeve and gauntlet by a certified lymphoedema therapist. If participants fit within measures for a ready to wear garment they will be provided with this, if they do not, a custom made sleeve and gauntlet will be provided.
- Standar
- Participants will be randomised to receive a low (15 - 25mmHg) or high (30 to 40mmHg) compression garment. All participants will wear the garments for 12 hours per day for 6 months and they will be provided 2 garments each. Participants will be measured for a Juzo sleeve and gauntlet by a certified lymphoedema therapist. If participants fit within measures for a ready to wear garment they will be provided with this, if they do not, a custom made sleeve and gauntlet will be provided. - Standardised, validated assessments will be conducted face to face at baseline and 6 months including: arm volume assessed by circumference-based measures and bioimpedance spectroscopy; patient-reported outcomes assessed by the Lymphoedema Quality of Life (ARM) questionnaire; tissue compliance assessed with the pitting test; lymphatic functioning, assessed by lymphoscintigraphy; and upper limb morphology, including dermal and subdermal thickness assessed by ultrasound, and fat volume within the lymphoedematous limb, assessed by both SPECT/CT and MRI. - Adherence to wearing the compression garment and garment care will be assessed by a weekly online questionnaire. - Pressure exerted by the compression garment will be checked (face to face) at 1 week and 2 and 4 months post baseline measures by a certified lymphoedema therapist.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosed with secondary arm lymphoedema (LE) equal or greater than 6 months but less than 5 years previously; - Secondary arm LE confirmed by arm measurements that surpass the 2 standard deviation thresholds for circumference measurements; - Completed any adjuvant cancer therapy (excluding hormone treatments) equal or greater than 6 months previously. - understand English.
Exclusion criteria
- choose not to be randomised to either the high or low pressure compression garment. - have a relative interlimb arm difference, assessed from wrist to 40cm proximal to the wrist, that is equal or greater than 30%; - have received decongestive therapy (ie massage and bandaging) within the last 6 months; - have a pacemaker, metal implant, suffer from claustrophobia, are unable to lie on their stomach with arms above their head or any other MRI-incompatible implant; - have primary or bilateral upper limb LE; and/or - are not available for ongoing assessments.
Outcome results
None listed