Malaria prevention method, the awareness of health service availability, and house related variables, by the use of TM for malaria symptoms.

<p>Malaria prevention method, the awareness of health service availability, and house related variables, by the use of TM for malaria symptoms.</p

Socio-demographic and lifestyle characteristics of adult Indonesians by the use of TM for malaria symptoms.

<p>Socio-demographic and lifestyle characteristics of adult Indonesians by the use of TM for malaria symptoms.</p

Multiple logistic regression for predicting use of TM for malaria symptoms (compared with not using TM for malaria symptoms).

<p>Multiple logistic regression for predicting use of TM for malaria symptoms (compared with not using TM for malaria symptoms).</p

sj-pdf-1-pmj-10.1177_02692163221122326 – Supplemental material for Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study

Supplemental material, sj-pdf-1-pmj-10.1177_02692163221122326 for Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study by Davinia SE Seah, Andrew Wilcock, Sungwon Chang, Mariana S Sousa, Aynharan Sinnarajah, Cy Oun Teoh, Simon Allan, Richard Chye, Matthew Doogue, Jane Hunt, Meera Agar and David C Currow in Palliative Medicine</p

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.</p

Assessment methods and tools used in this study.

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.</div

S1 File -

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.</div

List of inclusion and exclusion criteria.

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.</div

Study diagram.

*The optional extension is entirely based on participants’ preference for blinded continuation for weeks 13–24.</p

Schedule of enrollment, intervention and assessment.

PE, Physical examination; AKPS, Australia-modified Karnofsky Performance Status; SBT, Short Blessed Test; ECG, Electrocardiogram; FAACT, Functional Assessment of Anorexia Cachexia Treatment; CPR, C-reactive protein; IL-6, Interleukin 6; SCLC, small cell lung cancer; BMI, Body Mass Index; BIA, Bio-electrical impedance); DEXA, dual x-ray absorptiometry; CT, computed tomography; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; SQUASH, Short Questionnaire to Assess Health Enhancing Physical Activity; CGI-S, Clinical Global Impression of Severity; EQ-5D-5L, EuroQol 5-level 5-Dimensions; ICECAP-A, ICEpop CAPability Measure for Adults; TUG–Timed Up and Go test; CGI-I, Clinical Global Impression of Improvement; GIC, Global Impression of Change. a First telephone follow-up visit will occur 7 days after the Week 12 or Week 24 (if did not elect to enter extension) visit or the early termination visit due to withdrawal if treatment was ceased early. Subsequent telephone follow-up visits will occur every 7 days thereafter for a period of 4 weeks. There will be 4 follow-up visits in total. 1 Standard physical activity and dietary advice leaflets will be provided to both arms at baseline. 2 ICECAP-A will be administered after the EQ-5D-5L questionnaire.^ All electronically stored data from chest CT scans whenever they are done clinically will be used for evaluation of change in muscle mass at the thoracic (T4) level. *Only if people elect NOT to enter the extension. § Or withdrawal.</p