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

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: Genital Neoplasms, Female; Lymphedema
• Intervention / Treatment: Device: Bilateral leg compression stockings; Behavioral: Individualized exercise; Behavioral: Lymphedema risk reduction

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

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3S5
      • McGill University Health Centre Lymphedema Support Centre

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	Device: Bilateral leg compression stockings; 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.; Behavioral: Individualized exercise; Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques; Behavioral: Lymphedema risk reduction; 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.	Behavioral: 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	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	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	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	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

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Jewish General Hospital
• 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

General Publications

• 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.

Study record dates

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: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Lymphedema; Genital Neoplasms, Female
• Other Study ID Numbers: A11-M104-14B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No