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

NCT ID: NCT02966327

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2019-10-31

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.

Conditions

Genital Neoplasms, Female; Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bilateral leg compression stockings

Intervention Type: DEVICE

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.

Individualized exercise

Intervention Type: BEHAVIORAL

Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques

Lymphedema risk reduction

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Lymphedema risk reduction

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

Individualized exercise

Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques

Intervention Type: BEHAVIORAL

Lymphedema risk reduction

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Shirin M. Shallwani

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirin M. Shallwani, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Anna Towers, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre Lymphedema Support Centre

Montreal, Quebec, Canada

Countries

Canada

References

Shallwani SM, Towers A, Newman A, Salvador S, Yung A, Gilbert L, Gotlieb WH, Zeng X, Thomas D. Feasibility of a Pilot Randomized Controlled Trial Examining a Multidimensional Intervention in Women with Gynecological Cancer at Risk of Lymphedema. Curr Oncol. 2021 Jan 13;28(1):455-470. doi: 10.3390/curroncol28010048.

Reference Type: DERIVED

PMID: 33450972 (View on PubMed)

Other Identifiers

A11-M104-14B

Identifier Type: -

Identifier Source: org_study_id