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足部反射疗法对消化或肺癌患者化疗引起的恶心和呕吐的影响:随机对照试验

The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial.

作者信息

Murat-Ringot Audrey, Souquet Pierre Jean, Subtil Fabien, Boutitie Florent, Preau Marie, Piriou Vincent

机构信息

Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.

INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France.

出版信息

JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.

Abstract

BACKGROUND

Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer.

OBJECTIVE

The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem.

METHODS

This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy.

RESULTS

The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively).

CONCLUSIONS

This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/17232.

摘要

背景

癌症是一种慢性病,2017年全球发病率为2450万例,死亡960万例。肺癌和结直肠癌是男女最常见的癌症,根据国家和国际指南,铂类化疗是标准辅助治疗。这种化疗可能具有中度至高度致吐性。尽管采取了止吐治疗,但化疗引起的恶心和呕吐(CINV)可能仍然存在。此外,癌症患者对替代和补充药物越来越感兴趣,并表示希望在医院采用非药物治疗。在替代和补充药物中,足部反射疗法可显著降低乳腺癌患者CINV的严重程度。

目的

本研究的主要目的是评估足部反射疗法作为传统治疗的补充疗法,对消化或肺癌患者急性CINV严重程度的益处。评估的次要目标是延迟性CINV的频率和严重程度、生活质量、焦虑和自尊。

方法

本研究于2018年4月至2020年4月在法国里昂公民医院进行。这是一项开放标签随机对照试验。参与者被随机分为两组:干预组(即采用足部反射疗法的传统护理;n = 40)和对照组(即不采用足部反射疗法的传统护理;n = 40)。对门诊或住院患者进行足部反射疗法(每次30分钟)。符合条件的参与者为有铂类化疗指征的肺癌或消化癌患者。

结果

在化疗的第二个周期,采用视觉模拟量表评估急性恶心和呕吐的严重程度。对照组观察到至少增加2分的显著增加(7/34,21%;P = .001)。在所有周期中,足部反射疗法组延迟性恶心的频率有降低趋势(P = .28),止吐药物的使用频率显著降低(P = .04),呕吐方面无显著差异(P = .99);对照组延迟性恶心的严重程度有更强的感知趋势(P = .39)。在生活质量和焦虑方面,干预组和对照组之间无显著差异(分别为P = .32和P = .53)。

结论

本研究结果表明,足部反射疗法能显著更好地控制肺癌或消化癌患者的急性恶心严重程度,并减少止吐药物的使用。为了满足患者在医院使用非药物治疗以及补充和替代药物的愿望,足部反射疗法可作为传统止吐药物的补充干预措施提供。足部反射疗法未产生不良反应。为评估足部反射疗法在常规实践中的益处,需要在多个医疗中心进行一项更大规模的整群随机对照试验。

试验注册

ClinicalTrials.gov NCT03508180;https://clinicaltrials.gov/ct2/show/NCT03508180。

国际注册报告识别码(IRRID):RR2-10.2196/17232。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27e7/8663669/9562db808069/cancer_v7i4e25648_fig1.jpg

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