Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Amelie Harle
ORCID ID
Contact details
Department of Medical Oncology
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
-
Amelie.Harle@christie.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13989
Study information
Scientific title
A single-arm double-blind placebo-controlled cross-over trial of Aprepitant for the treatment of cough in lung cancer: CALC trial
Acronym
CALC
Study hypothesis
A single-arm placebo controlled crossover study of Aprepitant for the treatment of cough in lung cancer.
Aprepitant is an effective antitussive for patients with lung cancer.
Ethics approval
NRES Committee North West Liverpool East, 22/03/2013, ref: 13/NW/0084
Study design
Randomised single-arm placebo-controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell)
Intervention
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 doses.
Intervention type
Drug
Phase
Not Applicable
Drug names
Aprepitant
Primary outcome measure
Daytime ambulatory cough monitoring; Timepoint(s): Baseline, D3 and D9
Secondary outcome measures
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
Overall trial start date
01/04/2013
Overall trial end date
31/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Participant 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 patients ability to participate in the trial
Recruitment start date
01/04/2013
Recruitment end date
31/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Christie Hospital NHS Foundation Trust (UK)
Sponsor details
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
North West Lung Centre Charity (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/28148136