title: Is clarithromycin a potential treatment for cachexia in people with lung cancer? A feasibility study.
abstract: Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments. Over 6 months, none of 125 patients identified fulfilled the entry criteria. The commonest reasons for ineligibility were the use of an excluded concurrent drug (45, 36%), brain metastases (22, 18%), poor performance status (21, 17%) and current chemotherapy (15, 12%). A phase III trial of clarithromycin using these entry criteria is not feasible in this setting. Other macrolides that have a lower risk of a drug-drug interaction may be more practical to pursue.
authors.affiliation: Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Awan
authors.affiliation: Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
authors.forename: Vincent
authors.initials: V
authors.lastname: Crosby
authors.affiliation: Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Potter
authors.affiliation: Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
authors.forename: Ivo
authors.initials: I
authors.lastname: Hennig
authors.affiliation: Department of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
authors.forename: David
authors.initials: D
authors.lastname: Baldwin
authors.affiliation: Nottingham Health Science Partners, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Mehluli
authors.initials: M
authors.lastname: Ndlovu
authors.affiliation: Consumer representative, c/o National Cancer Research Institute, Angel Building, 407, St. John Street, London, EC1V 4AD, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: Paradine
authors.affiliation: Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. Electronic address: andrew.wilcock@nottingham.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wilcock
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000494:pharmacology; D002100:Cachexia / Q000188:drug therapy* / Q000401:mortality; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D017291:Clarithromycin / Q000008:administration & dosage* / Q000494:pharmacology; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D018942:Macrolides; D008297:Male; D055118:Medication Adherence; D009367:Neoplasm Staging; D010919:Placebos; D016032:Randomized Controlled Trials as Topic
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides; D010919:Placebos; D017291:Clarithromycin
keywords: Cachexia; Clarithromycin; Macrolide antibiotics; Non-small cell lung cancer