Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut.
Yale Cancer Center, New Haven, Connecticut.
JAMA Netw Open. 2023 Aug 1;6(8):e2326463. doi: 10.1001/jamanetworkopen.2023.26463.
Chemotherapy-induced peripheral neuropathy (CIPN), one of the most common and severe adverse effects of chemotherapy, is associated with worse quality of life among survivors of ovarian cancer. Currently, there is no effective treatment for CIPN.
To evaluate the effect of a 6-month aerobic exercise intervention vs attention-control on CIPN among women treated for ovarian cancer in the Women's Activity and Lifestyle Study in Connecticut (WALC) to provide evidence to inform the guidelines and recommendations for prevention or treatment of CIPN.
DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis evaluated the Women's Activity and Lifestyle Study in Connecticut (WALC), a multicentered, open-label, population-based, phase 3 randomized clinical trial of an aerobic exercise intervention vs attention control for CIPN in patients who were diagnosed with ovarian cancer. Only WALC participants who received chemotherapy were included in this analysis. Participants were randomized 1:1 to either a 6-month aerobic exercise intervention or to attention control. All analyses were conducted between September 2022 and January 2023.
The exercise intervention consisted of home-based moderate-intensity aerobic exercise facilitated by weekly telephone counseling from an American College of Sports Medicine/American Cancer Society-certified cancer exercise trainer. Attention control involved weekly health education telephone calls from a WALC staff member.
Change in CIPN was the primary outcome in this secondary analysis. This outcome was represented by CIPN severity, which was self-measured by participants at baseline and 6 months using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, with a score range of 0 to 44. A mixed-effects model was used to assess the 6-month change in CIPN between the exercise intervention and attention control arms.
Of the 134 participants (all females; mean [SD] age, 57.5 [8.3] years) included in the analysis, 69 were in the exercise intervention arm and 65 were in the attention control arm. The mean (SD) time since diagnosis was 1.7 (1.0) years. The mean (SD) baseline CIPN scores were 8.1 (5.6) in the exercise intervention arm and 8.8 (7.9) in the attention control arm (P = .56). At 6 months, the self-reported CIPN score was reduced by 1.3 (95% CI, -2.3 to -0.2) points in the exercise intervention arm compared with an increase of 0.4 (95% CI, -0.8 to 1.5) points in the attention control arm. The between-group difference was -1.6 (95% CI, -3.1 to -0.2) points. The point estimate was larger among the 127 patients with CIPN symptoms at enrollment (-2.0; 95% CI, -3.6 to -0.5 points).
Findings of this secondary analysis of the WALC trial indicate that a 6-month aerobic exercise intervention vs attention control significantly improved self-reported CIPN among patients who were treated for ovarian cancer. While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer.
ClinicalTrials.gov Identifier: NCT02107066.
重要性:化疗引起的周围神经病(CIPN)是化疗最常见和最严重的副作用之一,与卵巢癌幸存者的生活质量下降有关。目前,CIPN 没有有效的治疗方法。
目的:评估为期 6 个月的有氧运动干预与注意对照在康涅狄格州妇女活动和生活方式研究(WALC)中对接受卵巢癌治疗的女性中 CIPN 的影响,为预防或治疗 CIPN 的指南和建议提供证据。
设计、地点和参与者:这是一项预先指定的二次分析,评估了康涅狄格州妇女活动和生活方式研究(WALC),这是一项多中心、开放标签、基于人群的、针对接受卵巢癌治疗的患者的 CIPN 的有氧运动干预与注意对照的 3 期随机临床试验。仅包括在 WALC 中接受化疗的参与者。参与者按 1:1 随机分为 6 个月的有氧运动干预组或注意对照组。所有分析均在 2022 年 9 月至 2023 年 1 月之间进行。
干预措施:运动干预包括由美国运动医学学院/美国癌症协会认证的癌症运动训练师每周通过电话提供的家庭为基础的适度强度有氧运动。注意控制包括来自 WALC 工作人员的每周健康教育电话。
主要结果和测量:CIPN 的变化是这项二次分析的主要结果。这一结果由参与者在基线和 6 个月时使用癌症治疗功能评估/妇科肿瘤学组神经毒性量表自我测量的 CIPN 严重程度表示,得分范围为 0 到 44。使用混合效应模型评估了运动干预组和注意对照组之间 6 个月的 CIPN 变化。
结果:在纳入分析的 134 名参与者(均为女性;平均[标准差]年龄为 57.5[8.3]岁)中,69 名参与者在运动干预组,65 名参与者在注意对照组。诊断后平均(标准差)时间为 1.7(1.0)年。运动干预组的平均(标准差)基线 CIPN 评分为 8.1(5.6),注意对照组为 8.8(7.9)(P = .56)。在 6 个月时,与注意对照组相比,运动干预组的自我报告 CIPN 评分降低了 1.3(95%CI,-2.3 至-0.2)点,而注意对照组的评分增加了 0.4(95%CI,-0.8 至 1.5)点。两组间的差异为-1.6(95%CI,-3.1 至-0.2)点。在招募时已有 CIPN 症状的 127 名患者中,点估计值更大(-2.0;95%CI,-3.6 至-0.5 点)。
结论和相关性:WALC 试验的二次分析结果表明,与注意对照组相比,为期 6 个月的有氧运动干预可显著改善接受卵巢癌治疗的患者的自我报告 CIPN。虽然需要在其他研究中复制这些发现,但将转诊参加运动项目纳入标准肿瘤学护理可以减少卵巢癌患者的 CIPN 症状并提高生活质量。
试验注册:ClinicalTrials.gov 标识符:NCT02107066。