Topic: National Cancer Research Network
Conditions
Interventions
Patients will receive 3 days treatment with aprepitant/placebo at standard doses: 125mg D1, 80mg D2 and 80mg D3 followed by 3 days washout period and 3 further days of aprepitant/placebo at standard d
Sponsors
Christie Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daytime ambulatory cough monitoring; Timepoint(s): Baseline, D3 and D9 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomarker Analysis; Timepoint(s): Day 3 and Day 9 2. Cough Severity Visual Analogue Scale score; Timepoint(s): Baseline, Day 3 and Day 9 3. Manchester Cough in Lung Cancer Scale score; Timepoint(s): Baseline, Day 3 and Day 9 | — |
Countries
United Kingdom
Outcome results
None listed