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

ISRCTN	ISRCTN16200035
DOI	https://doi.org/10.1186/ISRCTN16200035
Secondary identifying numbers	13989

Submission date: 26/03/2013
Registration date: 26/03/2013
Last edited: 24/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-aprepitant-to-treat-cough-in-people-with-lung-cancer-calc

Contact information

Dr Amelie Harle
Scientific

Department of Medical Oncology
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Email	Amelie.Harle@christie.nhs.uk

Study information

Study design	Randomised single-arm placebo-controlled crossover study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	A single-arm double-blind placebo-controlled cross-over trial of Aprepitant for the treatment of cough in lung cancer: CALC trial
Study acronym	CALC
Study objectives	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(s)	NRES Committee North West Liverpool East, 22/03/2013, ref: 13/NW/0084
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2013
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 20; UK Sample Size: 20
Total final enrolment	20
Key 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
Key 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
Date of first enrolment	01/04/2013
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Christie Hospital NHS Foundation Trust

Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

550 Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

Website	http://www.christie.nhs.uk/
"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

North West Lung Centre Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	10/10/2015		Yes	No
Results article	results	15/03/2021	24/09/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

24/09/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
19/03/2019: Link to results (plain English) added.
07/02/2017: Publication reference added.