Chemotherapy-induced Peripheral NeuropathyPhase 2CHEMODEXNCT02271893
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
A Phase 2 study testing Dextromethorphan in people with Chemotherapy-induced Peripheral Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Dextromethorphan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2014to 21 Apr 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 years
- Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
- Numerical rating scale ≥ 4
- Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
- Patients affiliated to the French Social Security
- Patients with free and informed consent has been obtained
Who cannot join
- - Hypersensitivity to the active substance or to any of the excipients
- Hypertension
- History of stroke
- Severe heart failure
- Severe hepatic impairment
- Shortness of breath
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- Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
- Association with linezolid
- Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
- Diabetes (type I and II)
- Medical and surgical history incompatible with the study
- Patient receiving treatment with amantadine, ketamine, memantine, L-Dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, Monoamine oxidase inhibitor, dantrolene or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, amiodarone, fluoxetine, paroxetine, propafenone, thioridazine, ritonavir, nicotine, hydrochlorothiazide, warfarin
- Present or past psychotropic substances and alcohol dependence
- Childbearing age, no use of effective contraceptive method, pregnancy or lactation
- Patient exclusion period, or the total allowable compensation exceeded
- Patients undergoing a measure of legal protection (guardianship, supervision ...)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.
The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.
- Being tested
- Dextromethorphan
- Keywords
- Chemotherapy-induced peripheral neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan | Experimental | The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. Receives: Drug: Dextromethorphan |
| placebo | Placebo comparator | The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of average pain intensity by a numerical rating scale
Measured: 7 days before the visit at 1 month
Secondary outcomes (12)
Pain assessment by DN4
Measured: at 1 month
total neuropathy score clinical version (TNSc)
Measured: at 1 month
St Antoine questionnaire (QDSA)
Measured: at 1 month
Evaluation of analgesic consumption
Measured: at 1 month
Cognitive assessment by Trail Making Test A and B
Measured: at 1 month
Cognitive assessment by Digit Symbol Substitution Test
Measured: at 1 month
Cognitive assessment by FACT-COG test
Measured: at 1 month
Cognitive assessment by Purdue Pegboard Test
Measured: at 1 month
Quality of life assessment by EORTC QLQ-C30
Measured: at 1 month
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Measured: at 1 month
Quality of life assessment by Patient Global Impression of Change (PGIC)
Measured: at 1 month
Anxiety and Depression assessment by HAD scale
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start25 Nov 2014
- Primary completion26 Oct 2017
- Study completion21 Apr 2022
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Gisèle PICKERING, Dr Dominique JOLY / Dr Christine VILLATTE, Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD, Pr Claude DUBRAY
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271893
- Sponsor's protocol ID
- CHU-0214
- Other IDs
- 2014-000971-19, 2014
- Acronym
- CHEMODEX
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2014
- Last updated
- 10 Oct 2022
- Results posted
- No
Publications
Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.
PubMed 25636304
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
- ClinicalTrials.gov ID
- NCT02271893
- Acronym / sponsor ID
- CHEMODEX / CHU-0214
- Keywords
- Chemotherapy-induced peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Dr Gisèle PICKERING, Dr Dominique JOLY / Dr Christine VILLATTE, Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD, Pr Claude DUBRAY
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 22 Oct 2014 (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.
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
Detailed description
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.
The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan | Experimental | Drug: DextromethorphanThe aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. |
| placebo | Placebo comparator | Drug: DextromethorphanThe aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Age ≥ 18 years
- Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
- Numerical rating scale ≥ 4
- Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
- Patients affiliated to the French Social Security
Key exclusion criteria (16 listed)
- - Hypersensitivity to the active substance or to any of the excipients
- Hypertension
- History of stroke
- Severe heart failure
- Severe hepatic impairment
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 |
|---|---|---|
| DextromethorphanThe aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group. | Drug | Dextromethorphan, placebo |
Primary outcome
Measure of average pain intensity by a numerical rating scale
Time frame: 7 days before the visit at 1 month
12 secondary outcomes
Pain assessment by DN4
Time frame: at 1 month
total neuropathy score clinical version (TNSc)
Time frame: at 1 month
St Antoine questionnaire (QDSA)
Time frame: at 1 month
Evaluation of analgesic consumption
Time frame: at 1 month
Cognitive assessment by Trail Making Test A and B
Time frame: at 1 month
Cognitive assessment by Digit Symbol Substitution Test
Time frame: at 1 month
Cognitive assessment by FACT-COG test
Time frame: at 1 month
Cognitive assessment by Purdue Pegboard Test
Time frame: at 1 month
Quality of life assessment by EORTC QLQ-C30
Time frame: at 1 month
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time frame: at 1 month
Quality of life assessment by Patient Global Impression of Change (PGIC)
Time frame: at 1 month
Anxiety and Depression assessment by HAD scale
Time frame: at 1 month
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 25636304Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextromethorphan in people with Chemotherapy-induced Peripheral Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 16 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: Recruitment difficulties). 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?
Measure of average pain intensity by a numerical rating scale (time frame: 7 days before the visit at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271893, which also lists 1 linked publication.
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 10 Oct 2022.