HI-LO Trial in Lymphoedema – What is the optimal pressure for compression garments prescribed to women with upper limb lymphoedema

Not Applicable

• Conditions: Secondary arm lymphoedema; Cancer - Breast; Physical Medicine / Rehabilitation - Physiotherapy; Physical Medicine / Rehabilitation - Occupational therapy; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12618001689268
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-12
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in limb volume, derived by measurements of limb circumference.[Baseline and 6 months after randomisation]

Secondary Outcome Measures

Name	Time	Method
Volume of extracellular fluid, assessed with bioimpedance spectroscopy[Baseline and 6 months after randomisation];Tissue compliance assessed with the pitting test[Baseline and 6 months after randomisation];Patient reported outcomes using Lymphoedema Quality of Life Study (LYMQOL)<br>[Baseline and 6 months after randomisation];Lymphatic functioning assessed with lymphoscintigraphy <br>[Baseline and 6 months post randomisation];Upper limb morphology including fat volume assessed by MRI<br>[Baseline and 6 months after randomisation];Dermal and subdermal thickness using ultrasound (composite outcome)[Baseline and 6 months after randomisation];Upper limb morphology including fat volume assessed by SPECT/CT[Baseline and 6months post randomisation]