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

NCT02966327 | Completed

• 1 other identifier: A11-M104-14B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Neoplasms, Female; Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Compression Stockings-Exercise

EXPERIMENTAL

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; Behavioral: Individualized exercise; Behavioral: Lymphedema risk reduction

Control Group

OTHER

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

Interventions

Bilateral leg compression stockings 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.

Compression Stockings-Exercise

Individualized exercise BEHAVIORAL

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

Compression Stockings-Exercise

Lymphedema risk reduction BEHAVIORAL

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

Compression Stockings-Exercise; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• recurrent diagnosis of gynecological cancer;
• presence of distant metastases (stage 4 cancer);
• body mass index of 35 or greater.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Jewish General Hospital: collaborator

Study Sites (1)

McGill University Health Centre Lymphedema Support Centre

Montreal, Quebec, H4A 3S5, Canada

Location

Related Publications (1)

• 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.

  PMID: 33450972 DERIVED

MeSH Terms

Conditions

Genital Neoplasms, Female; Lymphedema

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 17, 2016
• Study Start: June 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: October 31, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)