Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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
|
| 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. |
Behavioral: Lymphedema risk reduction
Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McGill University Health Centre Lymphedema Support Centre | Montreal | Quebec | Canada | H4A 3S5 |
Sponsors and Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Jewish General Hospital
Investigators
- Principal Investigator: Shirin M. Shallwani, MSc, PT, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Anna Towers, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A11-M104-14B