Phase II, double blind, placebo controlled, multi-site study to evaluate the safety, feasibility and desirability of conducting a phase III study of anamorelin for anorexia in people with small cell lung cancer: A study protocol (LUANA trial).

Anorexia is experienced by most people with lung cancer during the course of their disease and treatment. Anorexia reduces response to chemotherapy and the ability of patients to cope with, and complete their treatment leading to greater morbidity, poorer prognosis and outcomes. Despite the significant importance of cancer-related anorexia, current therapies are limited, have marginal benefits and unwarranted side effects. In this multi-site, randomised, double blind, placebo controlled, phase II trial, participants will be randomly assigned (1:1) to receive once-daily oral dosing of 100mg of anamorelin HCl or matched placebo for 12 weeks. Participants can then opt into an extension phase to receive blinded intervention for another 12 weeks (weeks 13-24) at the same dose and frequency. Adults (≥18 years) with small cell lung cancer (SCLC); newly diagnosed with planned systemic therapy OR with first recurrence of disease following a documented disease-free interval ≥6 months, AND with anorexia (i.e., ≤ 37 points on the 12-item Functional Assessment of Anorexia Cachexia Treatment (FAACT A/CS) scale) will be invited to participate. Primary outcomes are safety, desirability and feasibility outcomes related to participant recruitment, adherence to interventions, and completion of study tools to inform the design of a robust Phase III effectiveness trial. Secondary outcomes are the effects of study interventions on body weight and composition, functional status, nutritional intake, biochemistry, fatigue, harms, survival and quality of life. Primary and secondary efficacy analysis will be conducted at 12 weeks. Additional exploratory efficacy and safety analyses will also be conducted at 24 weeks to collect data over longer treatment duration. The feasibility of economic evaluations in Phase III trial will be assessed, including the indicative costs and benefits of anamorelin for SCLC to the healthcare system and society, the choice of methods for data collection and the future evaluation design. Trial registration. The trial has been registered with the Australian New Zealand Clinical Trials Registry [ACTRN12622000129785] and approved by the South Western Sydney Local Health District Human Research Ethics Committee [2021/ETH11339]. https://clin.larvol.com/trial-detail/ACTRN12622000129785.

Chromatographic, Chemometric and Antioxidant Assessment of the Equivalence of Granules and Herbal Materials of Angelicae sinensis Radix.

Background: Granules are a popular way of administrating herbal decoctions. However, there are no standardised quality control methods for granules, with few studies comparing the granules to traditional herbal decoctions. This study developed a multi-analytical platform to compare the quality of granule products to herb/decoction pieces of Angelicae Sinensis Radix (Danggui). Methods: A validated ultra-performance liquid chromatography coupled with photodiode array detector (UPLC-PDA) method quantitatively compared the aqueous extracts. Hierarchical agglomerative clustering analysis (HCA) and principal component analysis (PCA) clustered the samples according to three chemical compounds: ferulic acid, caffeic acid and Z-ligustilide. Ferric ion-reducing antioxidant power (FRAP) and 2,2-Diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH) assessed the antioxidant activity of the samples. Results: HCA and PCA allocated the samples into two main groups: granule products and herb/decoction pieces. Greater differentiation between the samples was obtained with three chemical markers compared to using one marker. The herb/decoction pieces group showed comparatively higher extraction yields and significantly higher DPPH and FRAP (p < 0.05), which was positively correlated to caffeic acid and ferulic acid, respectively. Conclusions: The results confirm the need for the quality assessment of granule products using more than one chemical marker for widespread practitioner and consumer use.