ABSTRACT
Background and Objective: Chemotherapy and supportive care are alternative treatments in non-resectable cholangiocarcinoma patients. The adverse events from disease and treatments have been reported which affect quality of life (QOL) of the patients. The primary objective of this study was to evaluate the effect of melatonin on QOL of non-resectable cholangiocarcinoma patients.Methods: The study was a randomized, double-blind, placebo, controlled trial. Non-resectable cholangiocarcinoma patients were randomized by mixed-block randomization stratified by hospital and type of treatment. The treatment group received melatonin (20 mg/day); the control group received placebo. The patients started taking the study drug on the first day of the treatment and continued for three months. The QOL was assessed using Thai Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-HEP) and adverse events were assessed using Common Toxicity Criteria Adverse Events (CTCAE).Result: There were 30 patients recruited in the study, divided into 15 patients in each group. After 1 month of treatment, QOL of patients in the melatonin group decreased but not significantly while those in the control group showed significantly worse in many domains. Melatonin group had higher percentage of improvement in FACT-Hep scores than the control in both the first (20% vs 6.7%) and the second (20% vs 6.7%) month, but not significant. The median survival was longer in the melatonin group (160 vs. 130 days), but it is not significantly different. In addition, there were fewer reports of moderate to severe adverse events (Grade 3-5) in the melatonin group than placebo at two months in terms of anorexia (1 vs. 5), fatigue (1 vs. 5), nausea/vomiting (0 vs. 1), weight loss (2 vs. 9) and weight loss was greater than 5% from baseline (1 vs. 6).Conclusion: The combination of melatonin with standard treatment did not prolong overall survival period. The melatonin treatment, however, decreased adverse events and maintained QOL of non-resectable cholangiocarcinoma patients. Further studies with larger samples are needed.Keywords : Melatonin, Cholangiocarcinoma, Quality of Life
ABSTRACT
This study was of longitudinal prospective design and sough to evaluate quality of life (QOL) of cholangiocarcinoma patients at before and one month after treatment. The incidence of adverse events and their impact on a patient’s QOL were also analyzed. The study population were new patients with cholangiocarcinoma receiving treatment at Khon Kaen or Srinagarind Hospitals. QOL was assessed using Thai Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4 and adverse events were assessed using Common Toxicity Criteria Adverse Event (CTCAE) version 3. The report of QOL was categorized as improved, no change and worsening based on clinical meaningful scores of the measures. The mean difference of QOL scores before and after treatment, the relation of adverse events, and their severity on QOL were analyzed using Wilcoxon Sign rank test, Mann-Whitney U test and Kruskal Wallis, respectively. Preliminary results from 16 cholangiocarcinoma patients indicate that. Most patients were male (69%), median age 59, able to work or do high activities at baseline (ECOG ≤ 1, 87%) and only 12 out of 16 patients received chemotherapy treatment (75%). After a one month period, 12 out of 16 patients reported no change or worsening QOL (75%). The most common adverse events reported were fatigue (69%), anorexia (69%), weight loss (44%) and nausea/vomiting (37%). There were more reports of grade 3 or 4 adverse events at one month after treatment in terms of fatigue (12.6% vs. 6.3%), anorexia (43.8% vs. 18.8%) and nausea/vomiting (12.5% vs. 6.3%) compared to baseline. Patients experiencing weight loss after the treatments had reported a statistically significant lower QOL than those without (p \< 0.05). The alteration of fatigue severity from worsening, no-change or better after treatment has significantly affected QOL of these patients (p=0.05).