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Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?

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ClinicalTrials.gov Identifier: NCT02416570
Recruitment Status : Terminated (At 6 months 1 participant recruited. Study deemed not feasible and discontinued.)
First Posted : April 15, 2015
Last Update Posted : September 16, 2016
Sponsor:
Collaborator:
Roy Castle Lung Cancer Foundation
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE April 15, 2015
Last Update Posted Date September 16, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
Feasibility of a phase 3 study [ Time Frame: 1 year ]
The number of patients recruited to the study as a measure of feasibility.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02416570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
  • Tolerability of clarithromycin [ Time Frame: 1 year ]
    Number of patients taking >80% of prescribed doses as a measure of tolerability.
  • Safety of clarithromycin [ Time Frame: 1 year ]
    Number of adverse events as a measure of safety.
  • Safety of clarithromycin [ Time Frame: 1 year ]
    Number of patients with prolongation of the QT interval as a measure of safety.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in body composition at 8 weeks as a measure of effect.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in hand grip strength at 8 weeks as a measure of effect.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in 5 repetition sit to stand test speed at 8 weeks as a measure of effect.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in 4 metre gait speed at 8 weeks as a measure of effect.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in EQ-5D-5L at 8 weeks as a measure of effect.
  • Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in QLC Q30 at 8 weeks as a measure of effect.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
Official Title  ICMJE Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
Brief Summary This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive a placebo.
Detailed Description

Clarithromycin has been reported to significantly improve markers of inflammation, body weight, need for hospital admission and survival in 42 patients with NSCLC. Compared to patients receiving best supportive care only, those receiving Clarithromycin had an improved median survival of ~8 months (535 vs. 277 days), stayed at home longer (439 vs. 139 days) and reported no adverse effects.

In another study, 33 patients with NSCLC were given Clarithromycin for 3 months and compared to a matched control group there was a reduction in IL-6 levels which correlated with an improvement in body weight (gain 4 vs. 1kg) and survival. Thus, by reducing inflammation, Clarithromycin may be impeding the cachectic process, preserving body weight, physical function and independence and increasing survival.

These studies of Clarithromycin in NSCLC have limitations, e.g. lack of placebo-control, no direct assessment of lean body mass.

This feasibility study will obtain data to inform the viability and design of a larger randomised, double-blind, placebo-controlled, phase III study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cachexia
  • Lung Cancer
Intervention  ICMJE
  • Drug: Clarithromycin
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Clarithromycin
    Clarithromycin 250mg by mouth twice a day for 8 weeks
    Intervention: Drug: Clarithromycin
  • Placebo Comparator: Placebo
    Placebo matched capsule one capsule by mouth twice a day for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 1, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2015)
24
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with stage IV, pathologically confirmed, NSCLC not suitable for/declining/not tolerating 1st/2nd-line palliative chemotherapy, or following completion of 1st/2nd-line palliative chemotherapy
  • A likely prognosis of ≥3 months.
  • Cachexia on the basis of any of the following, weight loss >5% over past 6 months, or BMI <20kg/m2 and weight loss >2%, or appendicular skeletal muscle index determined by duel energy x-ray absorptiometry consistent with sarcopenia and weight loss >2%.
  • Systemic inflammation on the basis of a C-reactive protein >10mg/L.
  • Adequate renal function as defined by creatinine ≤132micromol/L and eGFR ≥30mL/min/1.73m2
  • Adequate liver function as defined by the following parameters, bilirubin ≤25micromol/L, and AST and ALT ≤2 times upper limit of normal, unless liver metastases, in which case ≤5 times upper limit of normal
  • Prepared to suspend, if necessary, the use of certain statins and/or substitute the use of domperidone for an alternative anti-emetic for the duration of the study

Exclusion Criteria:

  • ECOG Performance Status 3 or 4
  • Little or no food intake
  • Weight loss >10% in 1 month or >20% in total
  • Known hypersensitivity to clarithromycin
  • Inability to accurately measure QT interval, e.g. atrial fibrillation
  • QTc prolongation >450 milliseconds in a male, or 470 milliseconds in a female
  • History of ventricular arrhythmia
  • Severe cardiac insufficiency (NYHA class >2)
  • Untreated hypokalaemia/hypomagnesaemia
  • Active infection requiring antibiotics
  • Current or recent (within last 4 weeks) history of Clostridium difficile, eating disorder, dysphagia, malabsorption or diarrhoea
  • Untreated adrenal or thyroid diseases
  • Brain metastases
  • Use of corticosteroids/progestogens
  • Use of chemotherapy, other immunosuppressive, or antiviral (e.g. hepatitis C, HIV) drugs within 4 weeks
  • Drugs which are contra-indicated (except certain statins which can be temporarily suspended and domperidone which can be substituted for an alternative anti-emetic) or should be avoided in patients receiving clarithromycin, either because of the risk of a drug-drug interaction and/or prolonged QT
  • Pregnancy
  • Breast Feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02416570
Other Study ID Numbers  ICMJE 14102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Roy Castle Lung Cancer Foundation
Investigators  ICMJE
Principal Investigator: Andrew Wilcock University of Nottingham
PRS Account University of Nottingham
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP