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

Lymphedema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966327
• Other study ID #: A11-M104-14B
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Lymphedema

Intervention

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
• Lymphedema risk reduction
Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec

Locations

Country	Name	City	State
Canada	McGill University Health Centre Lymphedema Support Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)