CancerPhase 2CINE-ENCT01278004
Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
A Phase 2 study testing Ethosuximide in people with Cancer and Peripheral Neuropathy, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Peripheral Neuropathy
- What is being tested?
- Ethosuximide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2010to Jul 2014
- 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
- Age >/= 18
- Diagnosis of cancer
- Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English (translators will not be used)
- Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of >12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of >4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain).
- Duration of chemotherapy-induced painful peripheral neuropathy >4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy.
- Able to attend research centre according to the required visit schedule.
- Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)
- Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.
Who cannot join
- Renal impairment (serum creatinine >1.5x normal level)
- Deranged liver function (AST>3x normal level)
- Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
- Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.
- Pregnancy
- Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng painful peripheral neuropathy of any other cause.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.
- Conditions
- Cancer, Peripheral Neuropathy
- Being tested
- Ethosuximide, Placebo
- Keywords
- Adult cancer patients with chemotherapy-induced painful peripheral neuropathy
- Medical subject headings
- Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthosuximideDrug
Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
| Drug | Experimental | Not described Receives: Drug: Ethosuximide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278004
- Sponsor's protocol ID
- CCR3116
- Acronym
- CINE-E
- Status last verified
- May 2016
- First submitted
- 13 Jan 2011
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01278004
- Acronym / sponsor ID
- CINE-E / CCR3116
- Conditions
- Cancer, Peripheral Neuropathy
- Keywords
- Adult cancer patients with chemotherapy-induced painful peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- May 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Jan 2011 (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 is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
| Drug | Experimental | Drug: Ethosuximide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >/= 18
- Diagnosis of cancer
- Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English (translators will not be used)
- Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of >12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of >4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain).
- Duration of chemotherapy-induced painful peripheral neuropathy >4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy.
Key exclusion criteria (6 listed)
- Renal impairment (serum creatinine >1.5x normal level)
- Deranged liver function (AST>3x normal level)
- Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
- Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.
- Pregnancy
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 |
|---|---|---|
| EthosuximideDrug will be dose escalated in order to reach maximum tolerated dose starting with 250mg. | Drug | Drug |
| PlaceboCapsule | Drug | Placebo |
Primary outcome
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethosuximide in people with Cancer and Peripheral Neuropathy, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale. (time frame: 6 weeks). 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 26 May 2016.