CALC trial: Aprepitant for the treatment of cough in lung cancer

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell); Cancer; Malignant neoplasm of bronchus and lung

• Registration Number: ISRCTN16200035
• Lead Sponsor: Christie Hospital NHS Foundation Trust (UK)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/28148136 2020 results in https://pubmed.ncbi.nlm.nih.gov/32966755/ (added 24/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Study Completion: 2014-03-31
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients willing and able to give consent for participation in the trial
2. Male or female aged 18 years or above
3. WHO PS 02
4. Diagnosed with lung cancer
5. Able and willing to participate in and comply with the trial schedule
6. Persistent cough >= 4 weeks
7. Not on anticancer therapy
8. No anticancer therapy planned to commence for the duration of the trial participation

Exclusion Criteria

1. Received anticancer therapy within 4 weeks of trial entry
2. Receiving Aprepitant therapy
3. Presence of a RTI within last 4 weeks
4. Previous adverse event to Aprepitant
5. Presence of constipation grade 2 or above (CTCAE v4)
6. Scheduled elective surgery or other procedures requiring sedation or general anaesthesia during trial period
7. Potentially fertile women of childbearing age
8. Currently participating in another research trial involving an investigational product
9. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial or affect the patient?s ability to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daytime ambulatory cough monitoring; Timepoint(s): Baseline, D3 and D9

Secondary Outcome Measures

Name	Time	Method
<br> 1. Biomarker Analysis; Timepoint(s): Day 3 and Day 9<br> 2. Cough Severity Visual Analogue Scale score; Timepoint(s): Baseline, Day 3 and Day 9<br> 3. Manchester Cough in Lung Cancer Scale score; Timepoint(s): Baseline, Day 3 and Day 9<br>