Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.
Purpose:
This study aimed to investigate whether the
extracellular-to-intracellular fluid volume (E/I) ratio can predict survival in
patients with metastatic cancer.
Methods:
Clinical data were
collected from April 2016 to March 2018. Patients aged ≥19 years with metastatic
solid tumor were eligible. Bioimpedance analysis was used to assess body fluid
distribution and the E/I ratio. Clinical characteristics, including laboratory
test results and nutrition status according to the E/I ratio, were analyzed. Cox
proportional hazards models and Kaplan-Meier analysis were used to identify risk
factors for mortality.
Results:
In total, 87 patients were included
in the study. The 87 patients were divided into 2 groups according to the median
E/I ratio: a high E/I group (E/I ratio ≥1.0, n = 43) and a low E/I group (E/I
ratio <1.0, n = 44). Poor performance status, fluid retention, malnutrition,
elevation of C-reactive protein levels, and decreases in hemoglobin, albumin,
and protein levels were significantly associated with the high E/I group. The
median overall survival time was 1.6 and 12.5 months in the high E/I and low E/I
groups, respectively (
P
< .001). In the multivariate
analysis, poor performance status, leukocytosis, fluid retention, and E/I ratio
were independent prognostic factors, and the E/I ratio was the strongest
prognostic factor predicting overall survival (hazard ratio = 3.49, 95%
confidence interval = 1.75-6.96,
P
< .001).
Conclusions:
The E/I ratio can predict survival time in
patients with metastatic cancer. More rigorous research is required to confirm
this result.
Objectives : The cancer incidence and cancer burden is increasing. In addition, the use of botanical agents in cancer care is increasing. This article aims to review a research strategy for botanical agents. Methods : The clinical studies of anticancer botanical agents and the papers about clinical research methodology of botanical agents were reviewed. Results : In phase I study, safety confirmation, optimal dose determination and drug interaction study are important. Most botanical agents have low toxicity and some have non-monotone dose response. Therefore, dose-response curve must be evaluated separately from the dose-toxicity curve to determine optimal dose. Although anticancer botanical agents can't shrink tumor size rapidly, they do extend survival. So, in phase Ⅱ study, response should be evaluated by the survival. Conclusions : Clinical research of botanical agents in cancer is different from traditional methods and strategies. Considering the characteristics of botanical agents and experimental mechanism is necessary in conducting botanical based clinical trials.
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