Clinical trial NCT02416570 (phase 2, status: terminated)
Conditions: cachexia, lung cancer
ICD codes: R64, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: clarithromycin, placebo
SMILES: [H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    at 6 months 1 participant recruited. study deemed not feasible and discontinued.
  
Eligibility 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