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Background About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco. Methods This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation. The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches, and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it by a further 8 weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated 1 year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO) levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health, quality of life, and fatigue. Discussion Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up. Trial registration ClinicalTrials.gov NCT05290025. Registered on 22 March 2022

OBJECTIVES: In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.MATERIALS AND METHODS: 170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.RESULTS: Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.CONCLUSION: TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.

Einar Furulund,1– 3 Mitra Bemanian,2,3 Nina Berggren,3 Tesfaye Madebo,2,4 Sara Hydle Rivedal,3 Torgeir Gilje Lid,1,5 Lars Thore Fadnes2,3 1Centre for Alcohol and Drug Research, Stavanger University Hospital, Stavanger, Norway; 2Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway; 3Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; 4Department of Respiratory Medicine, Stavanger University Hospital, Stavanger, Norway; 5Department of Public Health, University of Stavanger, Stavanger, NorwayCorrespondence: Einar FurulundCentre for Alcohol and Drug Research, Stavanger University Hospital, Stavanger, NorwayTel +4751518000Email Einar.Furulund@sus.noBackground: The role of nutrition and dietary patterns has been widely investigated in cancer, cardiovascular disease, and diabetes, but there are limited data on nutritional impact on COPD. This systematic review (PROSPERO-reg. no: CRD42020172712) aimed to investigate the effect of nutritional interventions on pulmonary and physical function, inflammation, and health-related quality of life among individuals with COPD.Methods: Systematic searches were conducted in Medline, Embase, and Cochrane, resulting in 3861 references. Studies focusing exclusively on inpatient-stays, underweight or obese patients were excluded. Double screening, extraction and bias assessment were conducted. Bias was assessed according to the Cochrane risk of bias tool for randomized controlled trials. Thirteen randomized controlled trials with 916 participants were included.Results: These trials investigated effects of protein supplementation, beetroot juice, increased fruit and vegetable intake, black seed oil, Tualang honey, Chlorella vulgaris-extract, whey-peptide containing nutritional drink, and increased macronutrient intake. The durations of the interventions were from weeks to a few months, and only one with duration > 1 year (investigating increased fruit/vegetable intake). The intervention increasing fruit/vegetables found improvement in pulmonary function tests. Some interventions observed effects on systemic inflammation, health-related quality of life and physical function, although with some mixed results. Five were classified as poor, five as fair, and three as good in terms of risk of bias and quality.Conclusion: Increasing intake of fruits and vegetables over prolonged periods might have positive effects on lung function in individuals with COPD. Some nutritional interventions also observed effects on systemic inflammation, health-related quality of life, and physical function, although with some mixed results. Many of the trials were underpowered, had high dropout rates, or had a high risk of bias. Further research should investigate effect of prolonged dietary interventions.Keywords: nutrition, lung function, inflammation, physical function, health-related quality of life