A phase II randomized, double-blind, placebo-controlled study of Nuvastatic (C50SEW505OESA), a standardized rosmarinic acid-rich polymolecular botanical extract formulation to reduce cancer-related fatigue in patients with solid tumors.

AIM: We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA) in improving cancer-related fatigue (CRF) among cancer patients. METHODS: This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA). RESULTS: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen's d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%). CONCLUSION: Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials. TRIAL REGISTRATION: ClinicalTrial.gov ID: NCT04546607. Study registration date (first submitted): 11-05-2020.

Laparoscopic right hemicolectomy for goblet-cell carcinoid of the appendix: report of a rare case and literature survey.

Tumors of the appendix are rare entities, and the majority of them are discovered accidentally during an investigation for other conditions. Laparoscopic surgery for appendiceal goblet-cell carcinoid (GCC) has only been reported once before. Our patient was incidentally discovered to have an appendiceal tumor and was referred to us for laparoscopy. The tumor involved the body of the appendix and was adherent to the cecum. A laparoscopic hemicolectomy was successfully performed for the patient. Postoperative recovery was uneventful. Histopathology confirmed an appendiceal goblet-cell carcinoid. Immunohistochemistry was negative for the neuroendocrine markers, CK20 and CK7. GCC is a rare tumor of the appendix. Hemicolectomy is indicated in specific situations, such as local involvement or tumor size >2 cm. In our patient, the tumor was adherent to the cecum and tumor size was 5 cm. Therefore, a laparoscopic right hemicolectomy was performed primarily. There are several reports in the literature supporting both the laparoscopic and open approaches. Laparoscopic surgery for appendiceal tumors is safe, feasible, and even may be beneficial.