Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to determine the effects of an open-labeled placebo (OLP) compared to a waitlist control (WL) in reducing cancer-related fatigue (CRF) in patients with advanced cancer using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). MATERIALS AND METHODS: In this randomized controlled trial, patients with fatigue ≥4/10 on Edmonton Symptom Assessment Scale (ESAS) were randomized to OLP one tablet twice a day or WL for 7 days. On day 8, patients of both arms received a placebo for 3 weeks. Changes in FACIT-F from baseline to day 8 (primary outcome) and at day 29, were assessed. Secondary outcomes included FACT-G, Multidimensional Fatigue Symptom Inventory-SF, Fatigue cluster (defined as a composite of ESAS fatigue, pain, and depression), Center for epidemiologic studies-depression, Godin leisure-time physical activity questionnaire, and global symptom evaluation. RESULTS: A total of 84/90 (93%) patients were evaluable. The mean (SD) FACIT-F change at day 8 was 6.6 (7.6) after OLP, vs. 2.1 (9.4) after WL (P = .016). On days 15 and 29, when all patients received OLP, there was a significant improvement in CRF and no difference between arms. There was also a significant improvement in ESAS fatigue, and fatigue cluster score in the OLP arm on day 8 of the study (0.029, and 0.044, respectively). There were no significant differences in other secondary outcomes and adverse events between groups. CONCLUSIONS: Open-labeled placebo was efficacious in reducing CRF and fatigue clusters in fatigued advanced cancer patients at the end of 1 week. The improvement in fatigue was maintained for 4 weeks. Further studies are needed.

The frequency and factors associated with the use of a dedicated Supportive Care Center Telephone Triaging Program in patients with advanced cancer at a comprehensive cancer center.

CONTEXT: There is limited literature on characteristics of telephone triage programs and the nature of interventions in palliative care. OBJECTIVES: Our aim was to determine frequency and type of care provided by a Supportive Care Center Telephone Triaging Program (SCCTP) in advanced cancer patients (ACPs). METHODS: Electronic medical records were reviewed of 400 consecutive ACPs referred to palliative care at a comprehensive cancer center and given access to the SCCTP: 200 from the outpatient (OP) supportive care center and 200 from inpatient (IP) palliative care given access after discharge. We reviewed call frequency, type, reason, and outcomes including pain and other symptoms (Edmonton Symptom Assessment Scale and Memorial Delirium Assessment Scale [MDAS]) associated with utilization of the SCCTP. RESULTS: A total of 375 patients were evaluable. One hundred fifteen of 400 patients (29%) used the SCCTP: 96 OPs (83%) used the SCCTP vs. only 19 IPs (17%) (P < 0.001). The most common reasons for calls were pain (24%), pain medication refills (24%), and counseling (12%). For 115 phone calls, 43% (145 of 340) of recommendations were regarding care at home and 56% were regarding opioids. Patients who used the SCCTP had worse pain (P = 0.006), fatigue (P = 0.045), depression (P = 0.041), and well-being (P = 0.015) and better MDAS scores (P = 0.014) compared with nonusers. OPs had a higher prevalence of symptom distress (P = 0.013), depression (P < 0.001), anxiety (P < 0.01), and insomnia scores (P = 0.001); MDAS scores were significantly higher in IPs (P < 0.001). CONCLUSION: In this study, we found that overall utilization of the SCCTP by ACPs referred to palliative care was relatively low at 28.7%. The use of the SCCTP was particularly poor among the IPs on discharge. Patients who used SCCTP had worse pain, fatigue, depression, and well-being scores and better delirium scores.

Effects of chitosan and oligochitosan on development and mitochondrial function of Rhizopus stolonifer.

The antifungal activities of chitosan and oligochitosan have been used to control postharvest decay of the fruits. The effect of chitosan and oligochitosan on mycelium growth, spore germination, and mitochondrial function of Rhizopus stolonifer was evaluated in order to establish a connection between fungus development and the main organelle in charge to provide energy to the cell. The mycelium growth of R. stolonifer was significantly reduced on minimum media amended with chitosan or oligochitosan. The highest antifungal indexes were obtained on media containing chitosan or oligochitosan at 2.0 mg ml(-1). Microscopic observation showed that chitosan and oligochitosan affected the spore germination and hyphae morphology. Both polymers increased oxygen consumption of R. stolonifer. Respiratory activity was restored with NADH in permeabilized treated and untreated cells, and was inhibited with rotenone and flavones. Complex III and IV were inhibited by antimycin A and cyanide, respectively, in treated and untreated cells. Chitosan and oligochitosan increased NADH dehydrogenase activity in isolated mitochondria. However, there were not changes in the cytochrome c oxidase and ATPase activities by effect of these polymers. These results suggest that both chitosan and oligochitosan affect the development of R. stolonifer and might be implicated in the mitochondrial dysfunction.

Efecto del quitosano en el desarrollo in vitro de rhizopus stolonifer ehrenb: fr) vuill en dos medios de cultivo / Effect of chitosan on the in vitro developtment of rhizopus stolonifer (ehrenb: fr) vuill on two culture medium

En este trabajo se evaluó el efecto antifúngico del quitosano (0; 0,5; 1,0; 1,5; 2,0 mg mL-1) en el desarrollo in vitro (crecimiento micelial, formación de cuerpos fructíferos, esporulación, germinación y liberación de proteínas) de Rhizopus stolonifer en dos medios de cultivo (papa dextrosa agar y medio mínimo). Los resultados obtenidos demostraron que el quitosano inhibió el crecimiento micelial de R. stolonifer en ambos medios de cultivo. El mayor índice antifúngico se observó en el medio papa dextrosa agar. El quitosano no afectó la formación de los cuerpos fructíferos de R. stolonifer en los medios estudiados. La esporulación y la germinación de las esporas se afectaron en ambos medios de cultivo por efecto de quitosano, siendo más notable en el medio medio mínimo. Se demostró la liberación de proteínas por efecto del quitosano en medio mínimo y caldo papa dextrosa. En general, en este estudio se evidenció el efecto antifúngico del quitosano en el desarrollo in vitro de Rhizopus stolonifer con independencia del medio de cultivo empleado. Sin embargo, en medio medio mínimo podrían observarse mejor los efectos antifúngicos del quitosano.

In this work the antifungal effect of chitosan (0, 0.5, 1.0, 1.5, 2.0 mg mL-1) on the in vitro development (mycelial growth, fruit bodies formation, sporulation, germination and proteins release) of Rhizopus stolonifer on two culture medium (Potato Dextrose Agar and Minimal medium) was evaluated. The obtained results demonstrated that chitosan inhibited the mycelial growth of R. stolonifer in both culture medium. The highest antifungal effect was observed on potato dextrose agar medium. Chitosan was not affected the fruit bodies formation of R. stolonifer on the studied medium. Sporulation and spore germination were affected in both culture mediun by effect of chitosan, it was more noticeable in minimal medium. It was demonstrated proteins release by effect of chitosan in minimal medium and potato dextrose broth medium. In general, in this study it was showed the antifungal effect of chitosan on in vitro development of Rhizopus stolonifer regardless of the culture medium used. However, in minimal medium could be observed best the antifungal effects of chitosan.