NeurotoxicityPhase 3NCT00301080
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
A Phase 3 study testing D-cycloserine in people with Neurotoxicity and Pain, run by Northwestern University at 2 sites in United States.
Trial summary
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotoxicity, Pain, Breast Cancer
- What is being tested?
- D-cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients will be at least 18 years of age.
- Patients will be experiencing moderate to severe peripheral neuropathic pain
- Patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
- Patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
- Patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
- Patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet
Show all 12Show fewer
- Patients must have breast cancer (any stage)
- Patients must be able to read and speak English and provide informed consent.
- Patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy.
- Patients must have an ECOG Performance Status < 3 and be able to attend the physician study visits
- Patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial.
- Patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy.
Who cannot join
- Patients will not have secondary cause of neuropathic pain including: HIV/AIDS,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
- Patients will not have a history of major depression or severe anxiety.
- Women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. Women who are currently pregnant will not be invited to participate in this study.
- Patients will not have a history of seizures.
- Patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611-3013
University of Wisconsin School of Medicine
Madison, Wisconsin
About this study
Official title: A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity.
Later, the design was changed to randomize patients to 1 of 3 arms as follows:
- D-cycloserine 50 mg twice daily for up to 12 weeks
- D-cycloserine 200 mg twice daily for up to 12 weeks
- Placebo twice daily for up to 12 weeks
- Conditions
- Neurotoxicity, Pain, Breast Cancer
- Being tested
- D-cycloserine, Placebo
- Keywords
- pain, neurotoxicity, breast cancer
- Medical subject headings
- Neurotoxicity Syndromes, Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called Cycloserine; Seromycin™
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo (original version) | Placebo comparator | Placebo administered orally twice per day for 4 weeks. Receives: Other: Placebo |
| D-cycloserine 200mg | Active comparator | D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. Receives: Drug: D-cycloserine |
| D-cycloserine 50 mg | Active comparator | D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. Receives: Drug: D-cycloserine |
| D-cycloserine 250mg | Active comparator | This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks. Receives: Drug: D-cycloserine |
| Placebo (revised version) | Placebo comparator | Placebo administered orally twice per day for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
Measured: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Secondary outcomes (4)
Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
Compare individual patients' self-reported pain relief scores before and after the treatment period.
Measured: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Measured: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.
Measured: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
Record the amount of opioid medication used by patients in each arm before and after the study treatment period.
Measured: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2007
- Study completionMay 2008
Why it stopped: Funding for the study fell through.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Paice, PhD, RN, Principal investigator, Northwestern UniversityJamie Von Roenn, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301080
- Sponsor's protocol ID
- NU 05CC2
- Other IDs
- 504-038
- Status last verified
- Nov 2013
- First submitted
- 8 Mar 2006
- Last updated
- 2 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00301080
- Acronym / sponsor ID
- NU 05CC2
- Conditions
- Neurotoxicity, Pain, Breast Cancer
- Keywords
- pain, neurotoxicity, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for the study fell through.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Posted 2 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.
Detailed description
This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity.
Later, the design was changed to randomize patients to 1 of 3 arms as follows:
- D-cycloserine 50 mg twice daily for up to 12 weeks
- D-cycloserine 200 mg twice daily for up to 12 weeks
- Placebo twice daily for up to 12 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo (original version) | Placebo comparator | Other: PlaceboPlacebo administered orally twice per day for 4 weeks. |
| D-cycloserine 200mg | Active comparator | Drug: D-cycloserineD-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. |
| D-cycloserine 50 mg | Active comparator | Drug: D-cycloserineD-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. |
| D-cycloserine 250mg | Active comparator | Drug: D-cycloserineThis was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks. |
| Placebo (revised version) | Placebo comparator | Other: PlaceboPlacebo administered orally twice per day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients will be at least 18 years of age.
- Patients will be experiencing moderate to severe peripheral neuropathic pain
- Patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
- Patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
- Patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
Key exclusion criteria (5 listed)
- Patients will not have secondary cause of neuropathic pain including: HIV/AIDS,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
- Patients will not have a history of major depression or severe anxiety.
- Women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. Women who are currently pregnant will not be invited to participate in this study.
- Patients will not have a history of seizures.
- Patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).
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 |
|---|---|---|
| D-cycloserineAlso: Cycloserine; Seromycin™ | Drug | D-cycloserine 200mg, D-cycloserine 250mg, D-cycloserine 50 mg |
| Placebo | Other | Placebo (original version), Placebo (revised version) |
Primary outcome
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
4 secondary outcomes
Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Judith Paice, PhD, RN principal investigator
Northwestern University
Jamie Von Roenn, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-cycloserine in people with Neurotoxicity and Pain, run by Northwestern University at 2 sites in United States.
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 12 inclusion and 5 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 2 Dec 2013. 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 States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory (time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 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 2 Dec 2013.