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.

中文翻译：

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一项试验性随机对照试验的可行性，以检查对有淋巴水肿风险的妇科癌症妇女进行多维干预

对于妇科癌症女性的非侵入性淋巴水肿风险降低策略知之甚少。了解影响随机对照试验 (RCT) 可行性的因素可以指导未来的研究。我们的目标是报告一项试验性 RCT 的设计和可行性，该试验检查针对有淋巴水肿风险的妇科癌症治疗的妇女进行的量身定制的多维干预，并探讨干预措施对 12 个月时淋巴水肿发生率的初步有效性。在这项单盲、平行组、多中心试点 RCT 中，新诊断的妇科癌症女性随机接受术后压力袜和个性化运动教育（干预组：IG）或单独接受降低淋巴水肿风险的教育（对照组：CG）。招聘率，记录保留和评估完成情况。通过监测不良事件和依从性来跟踪干预的安全性和可行性。临床结果在 12 个月内进行了评估：淋巴水肿的存在、圆周和体积测量、身体成分和生活质量。招募了 51 名女性，36 名接受了指定的干预。招聘率和 12 个月保留率分别为 47% 和 78%。两名参与者在干预分娩之前经历了术后蜂窝织炎。术后 3 个月和 6 个月，67% 和 63% 的 IG 使用压力≥42 小时/周，而 56% 每周进行≥150 分钟的中等强度运动。12 个月时淋巴水肿的累积发生率在 CG 中为 31%，在 IG 中为 31.9% (p = 0.88)。在受影响的参与者中，CG 中出现淋巴水肿的中位时间为 3.2 个月（范围，2.7-5.9），而 IG 中为 8.8 个月（范围，2.9-11.8）。开展探索降低妇科癌症淋巴水肿风险策略的研究试验是可行的，但具有挑战性。在这一人群中，量身定制的压缩和运动干预是安全可行的，并且可能会延迟淋巴水肿的发作。需要进一步的研究来确定这些策略在降低妇科癌症人群淋巴水肿风险方面的作用。在这一人群中，量身定制的压缩和运动干预是安全可行的，并且可能会延迟淋巴水肿的发生。需要进一步的研究来确定这些策略在降低妇科癌症人群淋巴水肿风险方面的作用。在这一人群中，量身定制的压缩和运动干预是安全可行的，并且可能会延迟淋巴水肿的发作。需要进一步的研究来确定这些策略在降低妇科癌症人群淋巴水肿风险方面的作用。