Aprepitant for the treatment of cough in lung cancer

• Research type

  Research Study

• Full title

  A single arm double-blind placebo controlled cross-over trial of Aprepitant for the treatment of cough in lung cancer: “CALC” Trial

• IRAS ID

  117898

• Contact name

  Amelie Harle

• Sponsor organisation

  The Christie NHS Foundation Trust

• Eudract number

  2013-000139-28

• Research summary

  The CALC trial is a single arm, double-blind placebo-controlled cross-over trial of Aprepitant for the treatment of cough in lung cancer. The aim of the study is to determine whether Aprepitant reduces cough frequency and improves cough related quality of life over placebo. The trial will be conducted at The Christie NHS Foundation Trust in 20 lung cancer outpatients. Eligible patients will take placebo or aprepitant for 3 days followed by 3 days of no treatment (washout period) followed by 3 days of placebo or aprepitant. Patient assessments will include the completion of the Manchester Cough in Lung Cancer Scale (a 10 item questionnaire), a Visual Analogue Scale (VAS) and 24 hour cough monitoring on Days 3 and 9. They will also undergo a blood test on Day 3 and Day 9. Patients will require no follow-up beyond 9 days.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0084

• Date of REC Opinion

  22 Mar 2013

• REC opinion

  Further Information Favourable Opinion