CachexiaPhase 2NCT02416570
Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
A Phase 2 study testing Clarithromycin in people with Cachexia and Lung Cancer, run by University of Nottingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Lung Cancer
- What is being tested?
- Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Cachexia, Lung Cancer
- Being tested
- Clarithromycin, Placebo
- Keywords
- Clarithromycin
- Medical subject headings
- Cachexia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin | Active comparator | Clarithromycin 250mg by mouth twice a day for 8 weeks Receives: Drug: Clarithromycin |
| Placebo | Placebo comparator | Placebo matched capsule one capsule by mouth twice a day for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a phase 3 study
The number of patients recruited to the study as a measure of feasibility.
Measured: 1 year
Secondary outcomes (9)
Tolerability of clarithromycin
Number of patients taking >80% of prescribed doses as a measure of tolerability.
Measured: 1 year
Safety of clarithromycin
Number of adverse events as a measure of safety.
Measured: 1 year
Safety of clarithromycin
Number of patients with prolongation of the QT interval as a measure of safety.
Measured: 1 year
Effect of clarithromycin
Change from baseline in body composition at 8 weeks as a measure of effect.
Measured: 1 year
Effect of clarithromycin
Change from baseline in hand grip strength at 8 weeks as a measure of effect.
Measured: 1 year
Effect of clarithromycin
Change from baseline in 5 repetition sit to stand test speed at 8 weeks as a measure of effect.
Measured: 1 year
Effect of clarithromycin
Change from baseline in 4 metre gait speed at 8 weeks as a measure of effect.
Measured: 1 year
Effect of clarithromycin
Change from baseline in EQ-5D-5L at 8 weeks as a measure of effect.
Measured: 1 year
Effect of clarithromycin
Change from baseline in QLC Q30 at 8 weeks as a measure of effect.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: At 6 months 1 participant recruited. Study deemed not feasible and discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Roy Castle Lung Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Wilcock, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416570
- Sponsor's protocol ID
- 14102
- Status last verified
- Sep 2016
- First submitted
- 6 Mar 2015
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
- ClinicalTrials.gov ID
- NCT02416570
- Acronym / sponsor ID
- 14102
- Conditions
- Cachexia, Lung Cancer
- Keywords
- Clarithromycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At 6 months 1 participant recruited. Study deemed not feasible and discontinued.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Roy Castle Lung Cancer Foundation
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin | Active comparator | Drug: ClarithromycinClarithromycin 250mg by mouth twice a day for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matched capsule one capsule by mouth twice a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarithromycin | Drug | Clarithromycin |
| Placebo | Drug | Placebo |
Primary outcome
Feasibility of a phase 3 study
Time frame: 1 year
The number of patients recruited to the study as a measure of feasibility.
9 secondary outcomes
Tolerability of clarithromycin
Time frame: 1 year
Safety of clarithromycin
Time frame: 1 year
Safety of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Effect of clarithromycin
Time frame: 1 year
Results and safety
The study was stopped early (reason given: At 6 months 1 participant recruited. Study deemed not feasible and discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Wilcock principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clarithromycin in people with Cachexia and Lung Cancer, run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At 6 months 1 participant recruited. Study deemed not feasible and discontinued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a phase 3 study (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.