NCT02416570

Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive a placebo.

Detailed description

Clarithromycin has been reported to significantly improve markers of inflammation, body weight, need for hospital admission and survival in 42 patients with NSCLC. Compared to patients receiving best supportive care only, those receiving Clarithromycin had an improved median survival of \~8 months (535 vs. 277 days), stayed at home longer (439 vs. 139 days) and reported no adverse effects. In another study, 33 patients with NSCLC were given Clarithromycin for 3 months and compared to a matched control group there was a reduction in IL-6 levels which correlated with an improvement in body weight (gain 4 vs. 1kg) and survival. Thus, by reducing inflammation, Clarithromycin may be impeding the cachectic process, preserving body weight, physical function and independence and increasing survival. These studies of Clarithromycin in NSCLC have limitations, e.g. lack of placebo-control, no direct assessment of lean body mass. This feasibility study will obtain data to inform the viability and design of a larger randomised, double-blind, placebo-controlled, phase III study.

Conditions

• Cachexia
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Clarithromycin
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-04-15
• Last updated: 2016-09-16