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Trial record 13 of 389 for:    CLARITHROMYCIN

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

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.

Condition or disease Intervention/treatment Phase
Cachexia Lung Cancer Drug: Clarithromycin Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
Study Start Date : April 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Clarithromycin
Clarithromycin 250mg by mouth twice a day for 8 weeks
Drug: Clarithromycin
Placebo Comparator: Placebo
Placebo matched capsule one capsule by mouth twice a day for 8 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Feasibility of a phase 3 study [ Time Frame: 1 year ]
    The number of patients recruited to the study as a measure of feasibility.


Secondary Outcome Measures :
  1. Tolerability of clarithromycin [ Time Frame: 1 year ]
    Number of patients taking >80% of prescribed doses as a measure of tolerability.

  2. Safety of clarithromycin [ Time Frame: 1 year ]
    Number of adverse events as a measure of safety.

  3. Safety of clarithromycin [ Time Frame: 1 year ]
    Number of patients with prolongation of the QT interval as a measure of safety.

  4. Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in body composition at 8 weeks as a measure of effect.

  5. Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in hand grip strength at 8 weeks as a measure of effect.

  6. 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.

  7. Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in 4 metre gait speed at 8 weeks as a measure of effect.

  8. Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in EQ-5D-5L at 8 weeks as a measure of effect.

  9. Effect of clarithromycin [ Time Frame: 1 year ]
    Change from baseline in QLC Q30 at 8 weeks as a measure of effect.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416570


Sponsors and Collaborators
University of Nottingham
Roy Castle Lung Cancer Foundation
Investigators
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Principal Investigator: Andrew Wilcock University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02416570     History of Changes
Other Study ID Numbers: 14102
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Keywords provided by University of Nottingham:
Clarithromycin
Additional relevant MeSH terms:
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Clarithromycin
Lung Neoplasms
Wasting Syndrome
Cachexia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors