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BACKGROUND: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic colon cancer. Oxaliplatin is also used in the off-label treatment of gastric cancer. FDA uses post-marketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. It is necessary to perform safety monitoring after marketing authorization is received; such monitoring can be done by means of characterizing the safety of drugs in patients being treated in real-world clinical practice settings. OBJECTIVES: This Phase IV study aimed to evaluate the safety profile of a brand-name formulation of the generic drug oxaliplatin (Alvoxalâ, NanoAlvand, Tehran, Iran) in Iranian patients diagnosed with either colorectal or other, different types of cancer. METHODS: Patients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational Phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers. FINDINGS: A total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least 1 adverse event. Most of these adverse events were grade 1 or 2, and the most commonly reported adverse event was anemia (60.66%). During the study, 26 serious adverse events occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of adverse events in the system organ classes of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (ie, colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, postmarketing surveillance study demonstrated no unexpected safety findings from the use of this oxaliplatin product (Alvoxalâ) in Iranian patients diagnosed with different types of cancer. CONCLUSIONS: This Phase IV study provides data on the safety profile of a number of chemotherapy regimens containing an oxaliplatin product given to Iranian patients diagnosed with different types of cancer.
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Objective: Cancer is associated with some psychological problems that play an important role in the severity and continuity of cancer. Cancer may lead to maladaptive psychological reactions such as anxiety, depression, and fatigue. Depression and anxiety are highly prevalent in cancer patients. This study aimed to compare the efficacy of mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) for anxiety, depression, and fatigue in cancer patients. Method : The present study was a randomized clinical trial (RCT). Of the 100 patients diagnosed with cancer, 60 patients were eligible to participate in this study according to the inclusion / exclusion criteria. They were randomly assigned into 3 groups: MBCT, CBT, and wait-list group (WLG). Afterward, the experimental groups received 8 weekly treatment sessions. All the participants fulfilled the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Cancer-Related Fatigue Scale (CFS) before and after the intervention. Data were analyzed using SPSS-16 software by Analysis of Covariance (ANCOVA). Results: The results indicated a significant reduction in depression, anxiety, and fatigue scores in CBT and MBCT groups. There was a significant difference between both treatment groups with WLG in the anxiety and depression, but no significant difference was found between MBCT and CBT groups. Additionally, there was only a significant difference between the CBT group and WLG in terms of fatigue (P = 0.01). Conclusion: CBT and MBCT performed equally well in decreasing anxiety and depression in cancer patients, and they were significantly better than WLG. It seems that MBCT is a good alternative to CBT for decreasing emotional symptoms in cancer patients. As a result, CBT and MBCT could be considered a good addition to pharmacological treatment of cancer patients with comorbid psychological symptoms. However, CBT was preferable to MBCT in decreasing fatigue. The study was registered at the irct.ir database under registration number IRCT20180503039509N1.