一项针对一线化疗期间和之后卵巢癌患者的运动和营养干预的研究方案（BENITA）-一项随机对照试验。

Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial.

机构信息

Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

出版信息

BMC Cancer. 2024 Nov 11;24(1):1379. doi: 10.1186/s12885-024-13102-y.

DOI:10.1186/s12885-024-13102-y

PMID:39528997

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11552146/

Abstract

BACKGROUND

In ovarian cancer frequently reported side effects are muscle wasting and malnutrition, leading to frailty, decreased health-related quality of life (HRQoL), and cancer-related fatigue (CRF). Both often begin during first-line chemotherapy and develop progressively into a refractory state, if left untreated.

METHOD

Primary objective is to evaluate effectiveness of a newly developed app-based exercise and nutrition program under non-standardized conditions of clinical routine. We hypothize that patients who receive an individually tailored exercise and nutrition program for six months will have improved physical performance compared to patients who receive usual care. This is a multicenter randomized controlled open-label trial comparing an intervention group receiving a six-month exercise and nutrition intervention and a control group receiving usual care. Primary endpoint is the change in 6-Minute Walk Test (6MWT) from baseline to T2 (26 weeks after baseline) as a measure of physical functioning. Secondary endpoints include patients' utilization and adherence to the nutrition program (MEDAS), their malnutrition risk (NRS2002), as well as patients' HRQoL (see Table 1). Using the two-sample t-test with a two-sided type I error of 5% and 80% power, a medium effect size of Cohen's d = 0.50 can be demonstrated with a minimum of 128 participants (64 per group). With a conservatively estimated dropout rate of 30%, 182 patients will be recruited. Patients who are included must be over 18 years of age, be diagnosed with ovarian cancer, cancer of fallopian tubes, or peritoneal cancer, FIGO stages II-IV, receive surgery and chemotherapy (adjuvant or neoadjuvant). Exclusion criteria are an ECOG status greater than 2, inadequate proficiency in German, or physical or mental impairments hindering the implementation of the program or execution of study procedures.

DISCUSSION

In case of success, the project contributes in the long term to (i) improving medical care (diagnosis, psychoeducation, patient orientation, and empowerment), (ii) reducing the burden of disease and promoting physical autonomy for patients, and (iii) being incorporated into relevant guidelines.

TRIAL REGISTRATION

The study was registered at ClinicalTrials.gov (NCT06250686).

摘要

背景

卵巢癌常报告的副作用包括肌肉消耗和营养不良，导致虚弱、健康相关生活质量（HRQoL）下降和癌症相关疲劳（CRF）。如果不治疗，这些副作用通常在一线化疗期间开始，并逐渐发展为难治状态。

方法

主要目的是在临床常规的非标准化条件下评估新开发的基于应用程序的锻炼和营养计划的有效性。我们假设接受个性化定制的锻炼和营养计划六个月的患者与接受常规护理的患者相比，身体机能将得到改善。这是一项多中心随机对照开放标签试验，比较接受六个月锻炼和营养干预的干预组和接受常规护理的对照组。主要终点是从基线到 T2（基线后 26 周）的 6 分钟步行测试（6MWT）变化，作为身体功能的衡量标准。次要终点包括患者对营养计划的利用和依从性（MEDAS）、营养不良风险（NRS2002）以及患者的 HRQoL（见表 1）。使用具有双侧 5%类型 I 错误和 80%功效的双样本 t 检验，可以用最小的 128 名参与者（每组 64 名）证明中效大小的 Cohen's d = 0.50。保守估计的退出率为 30%，将招募 182 名患者。必须纳入年龄在 18 岁以上、被诊断为卵巢癌、输卵管癌或腹膜癌、FIGO 分期 II-IV 期、接受手术和化疗（辅助或新辅助）的患者。排除标准为 ECOG 状态大于 2、德语水平不足、或身体或精神障碍妨碍计划的实施或研究程序的执行。