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

McGill University

Status: Completed

Conditions: Genital Neoplasms, Female; Lymphedema

Treatments: Behavioral: Lymphedema risk reduction; Device: Bilateral leg compression stockings; Behavioral: Individualized exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02966327

A11-M104-14B

Details and patient eligibility

About

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 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Compression Stockings-Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Lymphedema risk reduction

Behavioral: Individualized exercise

Device: Bilateral leg compression stockings

Control Group

Other group

Description:

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.

Treatment:

Behavioral: Lymphedema risk reduction