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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2019

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Collaborator
    • Jewish General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shirin M. Shallwani, Physiotherapist – McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Overall Official(s)
    • Shirin M. Shallwani, MSc, PT, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
    • Anna Towers, MD, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

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