Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
BMC Cancer. 2020 Feb 27;20(1):158. doi: 10.1186/s12885-020-6618-9.
Cancer-related fatigue (CRF) is one of the most prevalent complications experienced by cancer patients during and after the process of treatment. Despite conducting a lot of studies, there is no approved therapy to help manage CRF. This study aims to investigate the efficacy of bupropion on CRF.
In this double-blind randomized placebo-controlled clinical trial, a total of 30 eligible cancer patients suffering from fatigue were randomly divided into two groups (15 patients in each group). Bupropion was administered 75 mg/day for the first three days and 150 mg/day (divided in two doses) till the end of the study at week 6. Fatigue as the primary outcome was measured by BFI (Brief Fatigue Inventory) and FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy) scales. Secondary outcomes included HADS (Hospital Anxiety and Depression Scale) and performance status (PS) measured by Karnofsky and ECOG (Eastern Cooperative Oncology Group) scales. Assessments were done at baseline, end of the second and sixth week.
There was no significant difference between placebo and bupropion at baseline and the end of second week. Significant difference was seen between two groups at the end of week six (P = 0.006 based on BFI) in favor of bupropion. In-group assessment showed improvement in fatigue levels in both groups during study time (P = 0.000 based on BFI for both bupropion and placebo). Secondary outcomes (e.g., HADS and PS) were not different at baseline and the end of second week. However, at the end of week six, the difference was significant in favor of bupropion.
A six-week trial of bupropion reduces the CRF and improves the PS of cancer patients.
Current Controlled Trials IRCT20090613002027N12, registration date: 2018-06-01.
癌症相关性疲劳（CRF）是癌症患者在治疗过程中及之后最常见的并发症之一。尽管进行了大量研究，但仍没有被批准的疗法来帮助管理 CRF。本研究旨在探究安非他酮治疗 CRF 的疗效。
在这项双盲随机安慰剂对照临床试验中，共有 30 名符合条件的患有疲劳的癌症患者被随机分为两组（每组 15 名患者）。安非他酮在前 3 天每天给药 75mg，在第 6 周的研究结束时每天给药 150mg（分两次服用）。主要结局指标为疲劳，通过 BFI（简短疲劳量表）和 FACIT-Fatigue（慢性疾病治疗功能评估量表）进行评估。次要结局指标包括 HADS（医院焦虑和抑郁量表）和 PS（卡诺夫斯基和 ECOG（东部合作肿瘤学组）量表）。评估在基线、第 2 周末和第 6 周末进行。
在基线和第 2 周末，安慰剂组和安非他酮组之间无显著差异。在第 6 周末，两组之间存在显著差异（基于 BFI，P=0.006），安非他酮组更优。组内评估显示，在研究期间，两组的疲劳水平均有所改善（基于 BFI，安非他酮和安慰剂均 P=0.000）。次要结局（如 HADS 和 PS）在基线和第 2 周末无差异。然而，在第 6 周末，安非他酮组的差异具有统计学意义。
为期 6 周的安非他酮治疗可减轻癌症患者的 CRF 并改善其 PS。
当前对照试验 IRCT20090613002027N12，注册日期：2018 年 6 月 1 日。
