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Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer

Primary Purpose

Genital Neoplasms, Female, Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bilateral leg compression stockings
Individualized exercise
Lymphedema risk reduction
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Genital Neoplasms, Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University Health Centre Lymphedema Support Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Compression Stockings-Exercise

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in bilateral lower limb volume
Measured with circumferential measures and perometry (Perometer 350S)

Secondary Outcome Measures

Change in bilateral lower limb extracellular fluid volume
Measured with bioimpedance spectroscopy
EORTC QLQ-C30 questionnaire
Measure of quality of life
Incidence of cellulitis
Patient-reported number of cellulitis infections

Full Information

First Posted
November 10, 2016
Last Updated
February 24, 2020
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02966327
Brief Title
Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer
Official Title
Effect of Early Compression Therapy and Individualized Exercise on Incidence of Lymphedema in Patients Treated for Gynecological Cancer: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Jewish General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Neoplasms, Female, Lymphedema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression Stockings-Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bilateral leg compression stockings
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized exercise
Intervention Description
Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques
Intervention Type
Behavioral
Intervention Name(s)
Lymphedema risk reduction
Intervention Description
Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec
Primary Outcome Measure Information:
Title
Change in bilateral lower limb volume
Description
Measured with circumferential measures and perometry (Perometer 350S)
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)
Secondary Outcome Measure Information:
Title
Change in bilateral lower limb extracellular fluid volume
Description
Measured with bioimpedance spectroscopy
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)
Title
EORTC QLQ-C30 questionnaire
Description
Measure of quality of life
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)
Title
Incidence of cellulitis
Description
Patient-reported number of cellulitis infections
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirin M. Shallwani, MSc, PT
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Towers, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre Lymphedema Support Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33450972
Citation
Shallwani SM, Towers A, Newman A, Salvador S, Yung A, Gilbert L, Gotlieb WH, Zeng X, Thomas D. Feasibility of a Pilot Randomized Controlled Trial Examining a Multidimensional Intervention in Women with Gynecological Cancer at Risk of Lymphedema. Curr Oncol. 2021 Jan 13;28(1):455-470. doi: 10.3390/curroncol28010048.
Results Reference
derived

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Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer

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