Cough relating to lung cancer MedDRA version: 15.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864 MedDRA version: 15.1 Level: PT Classification code 10011224 Term: Cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Aprepitant
Product Name: Aprepitant
Product Code: NA
Pharmaceutical Form: Capsule
INN or Proposed INN: Aprepitant
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients willing and able to give consent for participation in the trial • Male or female aged 18 years or above • WHO PS 0-2 • Diagnosed with lung cancer • Able and willing to participate in and comply with the trial schedule • Persistent cough = 4 weeks • Not on anticancer therapy • No anticancer therapy planned to commence for the duration of the trial participation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Received anticancer therapy within 4 weeks of trial entry • Receiving Aprepitant therapy • Presence of a RTI within last 4 weeks. • Previous adverse event to Aprepitant • Presence of constipation grade 2 or above (CTCAE v4) • Scheduled elective surgery or other procedures requiring sedation or general anaesthesia during trial period • Potentially fertile women of child-bearing age • Currently participating in another research trial involving an investigational product • 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 |
|---|---|
| Primary end point(s): A comparison of the change from baseline in cough count for Aprepitant versus placebo. ;Timepoint(s) of evaluation of this end point: Day 3 and Day 9;Secondary Objective: • To determine the effect of Aprepitant on cough-specific quality of life (MCLCS) scores for lung cancer patients. • To determine the effect of Aprepitant on Visual Analogue Scale (VAS) scores for lung cancer patients. • To determine whether biomarkers can predict cough severity. These may include IL-6, IL-8, IL-10 & TNF-a • To determine whether Aprepitant should be tested in a larger definitive study ;Main Objective: 1) Does Aprepitant alleviate cough in lung cancer patients? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cough Severity Visual Analogue Scale Score Manchester Cough in Lung Cancer Scale Score Preliminary toxicity profile of Aprepitant Biomarker Level;Timepoint(s) of evaluation of this end point: all analysed on Day 3 and Day 9 | — |
Countries
United Kingdom
Contacts
Public ContactAmelie Harle
The Christie NHS Foundation Trust
Outcome results
None listed