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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Early Compression Therapy and Individualized Exercise on Incidence of Lymphedema in Patients Treated for Gynecological Cancer: a Pilot Randomized Controlled Trial

Conditions
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Genital Neoplasms, Female, Lymphedema

Intervention / Treatment
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* Device: Bilateral leg compression stockings
* Behavioral: Individualized exercise
* Behavioral: Lymphedema risk reduction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression Stockings-Exercise<br>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<br>* 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.<br>Behavioral: Individualized exercise<br>* Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques<br>Behavioral: Lymphedema risk reduction<br>* Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec<br>|
| Other: Control Group<br>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<br>* Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec<br>|

What is the study measuring?
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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) |