Feasibility of a Pilot Randomized Controlled Trial Examining a Multidimensional Intervention in Women with Gynecological Cancer at Risk of Lymphedema.

Anna Towers,Shannon Salvador,Walter H Gotlieb,Lucy Gilbert,Anne Newman,Xing Zeng,Angela Yung,Doneal Thomas,Shirin M Shallwani

doi:10.3390/curroncol28010048

Abstract

There is limited knowledge on non-invasive lymphedema risk-reduction strategies for women with gynecological cancer. Understanding factors influencing the feasibility of randomized controlled trials (RCTs) can guide future research. Our objectives are to report on the design and feasibility of a pilot RCT examining a tailored multidimensional intervention in women treated for gynecological cancer at risk of lymphedema and to explore the preliminary effectiveness of the intervention on lymphedema incidence at 12 months. In this pilot single-blinded, parallel-group, multi-centre RCT, women with newly diagnosed gynecological cancer were randomized to receive post-operative compression stockings and individualized exercise education (intervention group: IG) or education on lymphedema risk-reduction alone (control group: CG). Rates of recruitment, retention and assessment completion were recorded. Intervention safety and feasibility were tracked by monitoring adverse events and adherence. Clinical outcomes were evaluated over 12 months: presence of lymphedema, circumferential and volume measures, body composition and quality of life. Fifty-one women were recruited and 36 received the assigned intervention. Rates of recruitment and 12-month retention were 47% and 78%, respectively. Two participants experienced post-operative cellulitis, prior to intervention delivery. At three and six months post-operatively, 67% and 63% of the IG used compression ≥42 h/week, while 56% engaged in ≥150 weekly minutes of moderate-vigorous exercise. The cumulative incidence of lymphedema at 12 months was 31% in the CG and 31.9% in the IG (p = 0.88). In affected participants, lymphedema developed after a median time of 3.2 months (range, 2.7–5.9) in the CG vs. 8.8 months (range, 2.9–11.8) in the IG. Conducting research trials exploring lymphedema risk-reduction strategies in gynecological cancer is feasible but challenging. A tailored intervention of compression and exercise is safe and feasible in this population and may delay the onset of lymphedema. Further research is warranted to establish the role of these strategies in reducing the risk of lymphedema for the gynecological cancer population.

Highlights

Gynecological cancers comprise over 10% of new cancer cases affecting females and over 11,000 Canadian women were estimated to be diagnosed in 2019 alone [1]
The objectives of this report are: (a) to describe the design of a pilot randomized controlled trials (RCTs) examining a tailored multidimensional intervention in women treated for gynecological cancer at risk of developing lymphedema; (b) to report on feasibility of the study procedures; including participant recruitment, randomization and retention, outcome assessment procedures, as well as the delivery and components of the tailored intervention; and (c) to explore the preliminary effectiveness of the intervention on the cumulative incidence of lymphedema at 12 months
In the 10 participants who developed lymphedema, the median time to lymphedema diagnosis was 3.2 months in the control group (CG) vs. 8.8 months in the intervention group (IG). This is the first trial exploring a multidimensional intervention of compression therapy and individualized exercise education in women treated for gynecological cancer at risk of developing lymphedema

Summary

Introduction

Gynecological cancers comprise over 10% of new cancer cases affecting females and over 11,000 Canadian women were estimated to be diagnosed in 2019 alone [1]. The incidence of lower limb lymphedema in patients treated for gynecological cancers has been found to range from 20% to 45% [2,3,4]. Studies have demonstrated that while the majority of cases occur in the first year, the risk of developing lymphedema after gynecological cancer persists in the long term [4,5]. Disease and treatment-related risk factors for the development of gynecological cancer-related lymphedema include: diagnosis of vulvar cancer, surgical lymph node dissection, radiation therapy, adjuvant chemotherapy, and the presence of post-operative complications such as lymph cysts, lymphoceles and local infections [2,6,7,8,9,10,11,12,13,14,15]. Additional risk factors include obesity, older age and pre-treatment lymphedema [6,9,15]

Objectives

Methods

Results

Discussion

Conclusion