Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02187289 |
| Other study ID # |
HREBA CC-14-0066 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2014 |
| Est. completion date |
November 2019 |
Study information
| Verified date |
February 2021 |
| Source |
AHS Cancer Control Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Lymphedema (significant arm swelling on the surgical side) is one of the most common
complications following treatment for breast cancer. The impact of lymphedema is profound,
resulting in negative self image, increased anxiety and poorer quality of life. In time,
lymphedema can result in recurrent infections in the arm, functional impairment and pain.
Approximately 21% of women who undergo breast cancer treatment develop lymphedema.
Unfortunately this is a life-time condition which tends to worsen over time. Currently,
treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the
wearing of compression sleeves during the day for maintenance. This study hopes to show that
the addition of night-time compression creates a measurable reduction in arm volume and that
adding night-time compression to the standard care (daytime compression only) will produce
improvements in quality of life for breast cancer survivors.
Description:
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of
of treated breast cancer patients. An initial intensive rehabilitative treatment is usually
prescribed to reduce the lymphedema, followed by a maintenance program using compression
sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due
to the potential tourniquet effect of the sleeve rolling up or bunching during the night.
Compression Bandages (short stretch, low elasticity) can be used at night but proper
application takes 20-30 minutes, require skill to apply properly and are costly. Various
types of night-compression system garments (NCSGs) have been designed as alternatives to
Compression Bandages (CB).
The objectives of this study are to determine:
1. Whether the addition of night-time compression (using CB or NCSG) to standard care
(daytime compression only) improves control of arm lymphedema.
2. Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment
compliance and patient independence than use of Compression Bandages.
The hypotheses are that:
1. Standard care plus the addition of NCSG will provide statistically significant
improvement in management of arm lymphedema volume compared to standard care alone at 12
weeks.
2. Standard care plus the addition of Compression Bandages will provide statistically
significant improved management of arm lymphedema volume compared to standard care alone
at 12 weeks.
3. Standard care plus the addition of NCSG will provide statistically significant benefit
in quality of life, sleep and self-efficacy over standard care plus Compression
Bandaging at 12 weeks.
Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression
Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12
All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 -
24).
Sample size = 40 participants per group, for a total of 120 patients at three sites.
Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure
central randomization service administered by the Clinical Trials Unit of the Cross Cancer
Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema
severity (i.e. mild versus moderate lymphedema as per the classification criteria of the
International Society of Lymphology).
Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and
compared to that of the unaffected arm. BIA measures the impedance of flow from a low
alternating electrical current that is applied to the body through a skin electrode. BIA
records impedance values for each limb and provides an index that correlates with
quantitative measurements of volume increase in limb size seen in the arm with lymphedema.
This measurement will provide information on extracellular fluid changes that complements the
data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation
(blinded) will perform the measurements of arm volume using the perometer, bioimpedance
analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary
intervention will be 12 weeks. Following the 12-week intervention period, participants in the
CB and standard care groups will be measured for a NCSG.
The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal
observational design and provide an opportunity to examine factors related to long-term
adherence to night-time compression. Lymphedema specific questionnaires and subject diary
will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep
disturbance, self-efficacy and treatment adherence.
