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

Not Applicable

Completed

• Conditions: Genital Neoplasms, Female; Lymphedema

• Registration Number: NCT02966327
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Primary Completion: 2019-04-30
• Study Completion: 2019-10-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in bilateral lower limb volume	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 Outcome Measures

Name	Time	Method
Change in bilateral lower limb extracellular fluid volume	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	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	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

Trial Locations

Locations (1)

McGill University Health Centre Lymphedema Support Centre; 🇨🇦 Montreal, Quebec, Canada