Peripheral Neuropathy Grade 2 or GreaterPhase 2NCT01633281
Acupuncture for Peripheral Neuropathy
A Phase 2 study testing acupuncture in people with Peripheral Neuropathy Grade 2 or Greater, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Peripheral Neuropathy Grade 2 or Greater
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2012to Jun 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale in spite of adequate duration (at least 3 weeks) of previous treatment with Gabapentin or Pregabalin or are unable to tolerate these drugs. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed.
- 3. The patient's current or previous treatment must include bortezomib or thalidomide
- 4. ECOG Performance Status of 0, 1, or 2
Who cannot join
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of active infection.)
- Thrombocytopenia (platelet counts < 50x 109/L) on the day of acupuncture session
- Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- Concurrent use of anticoagulation agents.
- Known coagulopathy and taking heparin (including low molecular weight heparin) or warfarin at any dose. Patients on aspirin or non-steroidal anti-inflammatories are allowed to participate.
- Persistent absolute neutrophil counts of < 1 x 109/L
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- Active CNS disease.
- Patients having a cardiac pacemaker.
- Currently pregnant or lactating females.
- Severe diabetic neuropathy or neuropathy related to HIV.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Acupuncture for Bortezomib or Thalidomide -Induced Peripheral Neuropathy in Patients With Multiple Myeloma or Lymphoma
A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or thalidomide, which may compromise treatment outcome. This clinical study explores whether, by intervening early in its course using acupuncture, progression of PN can be reversed, stabilized or retarded thereby allowing continuation of treatment on schedule.
Read the detailed description
- The acupuncture treatment will start after patients have received at least 3 weeks of Gabapentin or Pregabalin at adequate dose without improvement in PN
- Two sessions of acupuncture per week, each of 30minutes duration, will be administered for a total of 10 sessions over 5 weeks. The needling will be done by the designated acupuncturist for all patients, delivered with electrical stimulation at a defined frequency.
- A fixed set of acupoints will be applied which include both local and distant points, based on both symptoms of PN and classification of TCM syndrome. Some degree of flexibility with addition or reduction of acupoints is allowed based on clinical indication. The acupoints needled each session will be recorded.
- Assessment of efficacy 4.1 Objective response : A complete neurological examination will be done at commencement of acupuncture and at end of acupuncture.
In addition, a full nerve conduction test will be done at beginning of acupuncture and at the end of 10 sessions of acupuncture.
4.2 Subjective assessment A quality of life questionnaire (FACT/GOG-NTX v4) will be filled in by patients at enrolment, commencement, at the 6th session and at the end of 10 sessions of acupuncture.
4.3 Scoring With both objective and subjective assessment, a Total Neuropathy Score can be calculated at each time point as a quantitative measurement of the severity of PN
- Statistical considerations The statistical analysis specifies that a lower limit of the two-sided 90 percent confidence interval for the overall positive response that exceeded 10 percent would be considered to be evidence of significant efficacy of acupuncture in retarding Bortezomib or thalidomide induced PN. Allowing a confidence interval width of 30%, the sample size needed will be 34 patients. To allow for a 10% drop-out, we plan to recruit a total of 40 patients
- Conditions
- Peripheral Neuropathy Grade 2 or Greater
- Being tested
- acupuncture
- Keywords
- peripheral neuropathy, acupuncture, Bortezomib, Thalidomide
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Ten sessions of acupuncture at 2x per week over 5 weeks will be given to patients. The acupuncture points include a standard set of obligatory points and additional points based on symptoms.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture treatment | Experimental | Not described Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in peripheral neuropathy
Measured: within the 5 weeks of acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: poor recruitment and expiry of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Grade 2 or GreaterStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Neuroscience Institute
- Responsible party
- Sponsor
- Investigators
- Yeh-Ching Linn, MBBS, MRCP, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633281
- Sponsor's protocol ID
- Acupuncture 001
- Status last verified
- Nov 2015
- First submitted
- 29 Jun 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Acupuncture for Bortezomib or Thalidomide -Induced Peripheral Neuropathy in Patients With Multiple Myeloma or Lymphoma
- ClinicalTrials.gov ID
- NCT01633281
- Acronym / sponsor ID
- Acupuncture 001
- Conditions
- Peripheral Neuropathy Grade 2 or Greater
- Keywords
- peripheral neuropathy, acupuncture, Bortezomib, Thalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment and expiry of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Neuroscience Institute
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jul 2012 (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.
A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or thalidomide, which may compromise treatment outcome. This clinical study explores whether, by intervening early in its course using acupuncture, progression of PN can be reversed, stabilized or retarded thereby allowing continuation of treatment on schedule.
Detailed description
- The acupuncture treatment will start after patients have received at least 3 weeks of Gabapentin or Pregabalin at adequate dose without improvement in PN
- Two sessions of acupuncture per week, each of 30minutes duration, will be administered for a total of 10 sessions over 5 weeks. The needling will be done by the designated acupuncturist for all patients, delivered with electrical stimulation at a defined frequency.
- A fixed set of acupoints will be applied which include both local and distant points, based on both symptoms of PN and classification of TCM syndrome. Some degree of flexibility with addition or reduction of acupoints is allowed based on clinical indication. The acupoints needled each session will be recorded.
- Assessment of efficacy 4.1 Objective response : A complete neurological examination will be done at commencement of acupuncture and at end of acupuncture.
In addition, a full nerve conduction test will be done at beginning of acupuncture and at the end of 10 sessions of acupuncture.
4.2 Subjective assessment A quality of life questionnaire (FACT/GOG-NTX v4) will be filled in by patients at enrolment, commencement, at the 6th session and at the end of 10 sessions of acupuncture.
4.3 Scoring With both objective and subjective assessment, a Total Neuropathy Score can be calculated at each time point as a quantitative measurement of the severity of PN
- Statistical considerations The statistical analysis specifies that a lower limit of the two-sided 90 percent confidence interval for the overall positive response that exceeded 10 percent would be considered to be evidence of significant efficacy of acupuncture in retarding Bortezomib or thalidomide induced PN. Allowing a confidence interval width of 30%, the sample size needed will be 34 patients. To allow for a 10% drop-out, we plan to recruit a total of 40 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acupuncture treatment | Experimental | Procedure: acupuncture |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 21 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale in spite of adequate duration (at least 3 weeks) of previous treatment with Gabapentin or Pregabalin or are unable to tolerate these drugs. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed.
- 3. The patient's current or previous treatment must include bortezomib or thalidomide
- 4. ECOG Performance Status of 0, 1, or 2
Key exclusion criteria (11 listed)
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of active infection.)
- Thrombocytopenia (platelet counts < 50x 109/L) on the day of acupuncture session
- Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- Concurrent use of anticoagulation agents.
- Known coagulopathy and taking heparin (including low molecular weight heparin) or warfarin at any dose. Patients on aspirin or non-steroidal anti-inflammatories are allowed to participate.
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 |
|---|---|---|
| acupunctureTen sessions of acupuncture at 2x per week over 5 weeks will be given to patients. The acupuncture points include a standard set of obligatory points and additional points based on symptoms. | Procedure or surgery | acupuncture treatment |
Primary outcome
Improvement in peripheral neuropathy
Time frame: within the 5 weeks of acupuncture treatment
Results and safety
The study was stopped early (reason given: poor recruitment and expiry of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Related trials for Peripheral Neuropathy Grade 2 or Greater
Recruiting
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater
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.
Yeh-Ching Linn, MBBS, MRCP principal investigator
Singapore General Hospital
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 acupuncture in people with Peripheral Neuropathy Grade 2 or Greater, run by Singapore General Hospital at 1 site in Singapore.
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 4 inclusion and 11 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 20 Nov 2015. 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 Singapore. 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. 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: poor recruitment and expiry of funding). 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?
Improvement in peripheral neuropathy (time frame: within the 5 weeks of acupuncture treatment). 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 20 Nov 2015.