Clinical trial · Interventional
Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
NCT02416570CI-TRIAL-00023912terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At 6 months 1 participant recruited. Study deemed not feasible and discontinued.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clarithromycin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clarithromycin
- description
- Clarithromycin 250mg by mouth twice a day for 8 weeks
- interventionNames
- Drug: Clarithromycin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo matched capsule one capsule by mouth twice a day for 8 weeks
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Feasibility of a phase 3 study
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.