Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer
February 24, 2020 updated by: Shirin M. Shallwani, McGill University Health Centre/Research Institute of the McGill University Health Centre
Effect of Early Compression Therapy and Individualized Exercise on Incidence of Lymphedema in Patients Treated for Gynecological Cancer: a Pilot Randomized Controlled Trial
Objectives: 1) To evaluate the effect of early compression therapy with individualized exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate the effect of early compression therapy with individualized exercise on lower limb volume, quality of life and incidence of cellulitis infections at 12 months post-operatively in this population.
Study Overview
Status
Completed
Conditions
Detailed Description
Study design and setting: A pilot randomized controlled trial will be conducted on 50 patients with gynecological cancer recruited from the McGill University Health Centre (MUHC) Royal Victoria Hospital and the Jewish General Hospital (JGH) Segal Cancer Centre in Montreal, Quebec. The data collection and interventions will be conducted at the MUHC Lymphedema Support Centre.
Intervention: At 4-6 weeks post-operatively, each participant in the experimental group will be prescribed Jobst Elvarex compression class 1 (18 to 21 mmHg) standard or custom-made stockings for both lower limbs with or without panty. The participants will be recommended to wear the garments for 12 to 16 hours daily for at least 6 months post-operatively. At this time, the participants will also receive individualized education on exercise, self-lymphatic drainage and skin care by an unblinded lymphedema therapist.
Control: At 4-6 weeks post-operatively (T2), both groups will receive standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3S5
- McGill University Health Centre Lymphedema Support Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- above 18 years of age;
- diagnosis of grade 2 or 3 endometrial cancer, or high grade type (serous or clear cell), stage 1b1 or stage 2a cervical cancer, stage 1 vulvar cancer with tumor greater than 4 cm, or stage 2 or 3 vulvar cancer;
- to undergo surgical lymph node dissection.
Exclusion Criteria:
- recurrent diagnosis of gynecological cancer;
- presence of distant metastases (stage 4 cancer);
- body mass index of 35 or greater.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compression Stockings-Exercise
At T2 (4-6 weeks post-operatively), 25 study participants will be randomized to the intervention group and will be prescribed compression stockings and individualized exercise.
They will also receive standard education on lymphedema risk reduction.
|
Prescribed Jobst Elvarex compression class 1 (18 to 21 mmHg) standard or custom-made stockings for both lower limbs with or without panty; participants will be recommended to wear the garments for 12 to 16 hours daily for at least 6 months post-operatively.
Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques
Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec
|
|
Other: Control Group
At T2 (4-6 weeks post-operatively), 25 study participants will be randomized to the control group and will receive standard education on lymphedema risk reduction.
|
Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bilateral lower limb volume
Time Frame: Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Measured with circumferential measures and perometry (Perometer 350S)
|
Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bilateral lower limb extracellular fluid volume
Time Frame: Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Measured with bioimpedance spectroscopy
|
Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
|
EORTC QLQ-C30 questionnaire
Time Frame: Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Measure of quality of life
|
Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
|
Incidence of cellulitis
Time Frame: Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Patient-reported number of cellulitis infections
|
Prior to surgery (T1), at 4-6 weeks post- operatively (T2), at 3 months post-operatively (T3), at 6 months post-operatively (T4) and at 1 year post-operatively (T5)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Shirin M. Shallwani, MSc, PT, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Anna Towers, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
October 31, 2019
Study Registration Dates
First Submitted
November 10, 2016
First Submitted That Met QC Criteria
November 14, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A11-M104-14B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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