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Clinical Trials/ISRCTN16200035
ISRCTN16200035
Completed
未知

A single-arm double-blind placebo-controlled cross-over trial of Aprepitant for the treatment of cough in lung cancer: CALC trial

Christie Hospital NHS Foundation Trust (UK)0 sites20 target enrollmentMarch 26, 2013
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ConditionsTopic: National Cancer Research NetworkSubtopic: Lung CancerDisease: Lung (small cell), Lung (non-small cell)CancerMalignant neoplasm of bronchus and lung

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: National Cancer Research Network
Sponsor
Christie Hospital NHS Foundation Trust (UK)
Enrollment
20
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/28148136 2020 results in https://pubmed.ncbi.nlm.nih.gov/32966755/ (added 24/09/2020)

Registry
who.int
Start Date
March 26, 2013
End Date
March 31, 2014
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Christie Hospital NHS Foundation Trust (UK)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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