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Information about side effects may exacerbate CINV due to the nocebo effect. This study aims to examine the efficacy of pharmacist-led enhanced support for coping with side effects during medication counselling, which includes providing information about side effects, with the goal of mitigating the nocebo effect and reducing CINV.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre exploratory open-label randomised controlled trial will examine the efficacy of pharmacist-led enhanced support for coping with the side effects of treatments during medication counselling in patients with advanced lung cancer. The control group will receive medication counselling as usual. The study population will consist of patients with advanced lung cancer who have not received chemotherapy and are receiving highly emetogenic chemotherapy or equivalent chemotherapy. The primary endpoint is the prevention of nausea, and the secondary endpoints include complete response (no vomiting event and no rescue medication), stress (objectively assessed using the salivary cortisol and immunoglobulin A), coping strategies and quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study received approval from the medical ethics committee of Kansai Medical University. The results will be submitted for publication in an international peer-reviewed journal, and the findings will be presented at international scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Protocol version<\/jats:title>\n                    <jats:p>1.0, 18 Mar 2025<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Registration number: UMIN000056068.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103580","type":"journal-article","created":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T15:45:19Z","timestamp":1770651919000},"page":"e103580","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of enhanced support for coping with side effects during medication counselling on the nocebo effect in patients with advanced lung cancer receiving initial chemotherapy: protocol for a multicentre exploratory open-label randomised controlled trial"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-7004-9889","authenticated-orcid":false,"given":"Ryohei","family":"Fujii","sequence":"first","affiliation":[{"name":"Department of Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka Prefecture, Japan"},{"name":"Department of Pharmacy, Kansai Medical University Hirakata Hospital, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5092-9377","authenticated-orcid":false,"given":"Yoshinobu","family":"Matsuda","sequence":"additional","affiliation":[{"name":"Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miyuki","family":"Okada","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kansai Medical University Hirakata Hospital, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruka","family":"Ishikura","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kansai Medical University Hirakata Hospital, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuke","family":"Imai","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kansai Medical University Hirakata Hospital, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Risako","family":"Muraoka","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kansai Medical University Hirakata Hospital, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4689-1203","authenticated-orcid":false,"given":"Hideaki","family":"Hasuo","sequence":"additional","affiliation":[{"name":"Department of Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,2,9]]},"reference":[{"key":"2026062610404666000_16.2.e103580.1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.05.6382"},{"key":"2026062610404666000_16.2.e103580.2","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1016\/j.critrevonc.2015.12.001","article-title":"Impact of chemotherapy-induced nausea and vomiting on health-related quality of life and resource utilization: A systematic review","volume":"99","author":"Sommariva","year":"2016","journal-title":"Crit Rev Oncol Hematol"},{"key":"2026062610404666000_16.2.e103580.3","first-page":"296","article-title":"Impact of chemotherapy-associated nausea and vomiting on patients\u2019 functional status and on costs: survey of five Canadian centres","volume":"149","author":"O\u2019Brien","year":"1993","journal-title":"CMAJ"},{"key":"2026062610404666000_16.2.e103580.4","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m4087","article-title":"Mortality due to cancer treatment delay: systematic review and meta-analysis","volume":"371","author":"Hanna","year":"2020","journal-title":"BMJ"},{"key":"2026062610404666000_16.2.e103580.5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.01296"},{"key":"2026062610404666000_16.2.e103580.6","doi-asserted-by":"crossref","unstructured":"Ruhlmann CH , Jordan K , Jahn F , et al . 2023 Updated MASCC\/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting. 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