Condition category
Cancer
Date applied
26/03/2013
Date assigned
26/03/2013
Last edited
11/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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, REC ref: 13/NW/0084

Study design

Randomised single-arm placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell)

Intervention

Aprepitant, 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

Other

Phase

Phase IV

Drug names

Primary outcome measures

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

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 patient’s 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

Department of Medical Oncology
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

http://www.christie.nhs.uk/

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes