LymphomaPhase 2NCT00891618
Acupuncture for Chemo-Induced Peripheral Neuropathy
A Phase 2 study testing Acupuncture in people with Lymphoma and Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Myeloma, Peripheral Neuropathy
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2013
- Phase
- Phase 2
- 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, or the legal guardians of patients, must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- Age > 18 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed. Patients will be removed from the study if a change in type of medication is necessary. All patients will receive treatment to both upper and lower extremities, regardless of whether or not they are experiencing symptoms in all four extremities.)
- The patient's previous chemotherapy treatment must have included thalidomide and/or bortezomib and/or any derivatives.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.
Who cannot join
- Current active treatment with thalidomide and/or bortezomib.
- 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 infection.)
- Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and anticoagulation agents.
- Known coagulopathy and taking heparin (including low molecular weight heparin) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories will be allowed to participate.
- Platelets < 50 H K/UL.
Show all 16Show fewer
- White Blood Counts (WBCs) < 3.0 K/UL.
- Active central nervous system (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
- Cardiac pacemaker.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
- Currently pregnant or lactating females. (Certain acupuncture applications have been reported to stimulate uterine contractions and may alter lactation.)
- Chronic alcohol use as clinically estimated by the patient's physician.
- History of diabetic neuropathy or neuropathy related to HIV.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
- Active treatment for lymphoma, non-Hodgkin's lymphoma or multiple myeloma.
- Planned or actual changes in type of medications that could affect symptoms related to peripheral neuropathy (PN). Note: Minor adjustments in current medications at the time of enrollment is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy.
Read the detailed description
Acupuncture:
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. In this study, the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Acupuncture Sessions:
Your first acupuncture session will be on the same day as the tests described above, if possible. (If not, it will be scheduled for another day that will be no more than about 10 days after the screening visit.)
You will have an acupuncture session 3 times per week for 4 weeks (Weeks 1-4). You will then have 1 week off (Week 5). After that, you will have an acupuncture session twice per week for 4 more weeks (Weeks 6-10). This is a total of 20 sessions. In addition to the 20 planned sessions, you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body where the needles will be placed. All study participants will have the needles placed at the same points on the body (the hands, feet, legs, abdomen, and scalp).
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures. The needles will remain in place for about 20-30 minutes.
Electrical stimulation will be added to some of the needles on the feet and hands. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level for you.
Study Procedures:
At each session, before you receive the acupuncture, the following procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may be experiencing.
- The color and coating of your tongue and the quality of your pulse will be recorded.
Once a week, you will also be asked to complete the same 3 questionnaires as you did at the beginning of the study.
Most study visits will last about 1 hour. On the weeks that you complete the questionnaires, it may add about 15-20 minutes.
During the study, you may still receive your regular pain treatments. If you are receiving Neurontin (gabapentin), Cymbalta (duloxetine), and/or Lyrica (pregabalin), you must stay on the same drug(s) until you go off this study. Minor changes in the doses of your pain treatments are allowed, but if there is a large change, you will be taken off study early.
Length of Study Participation:
You may receive up to 21 acupuncture sessions over 13 weeks. If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
At Week 13, or if you go off study early for any reason, you will have an end-of-study visit. If the doctor thinks it is necessary, the following procedures will be performed:
- Your medical history will be recorded.
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have experienced.
- You will complete the same 3 questionnaires as before.
- The 4 nerve tests will be repeated in order to learn if there have been any changes in your nerve function.
- Your tongue and pulse will be evaluated.
After the end-of-study visit, your participation in this study will be over.
This is an investigational study. The acupuncture needles used in this study are commercially available and FDA approved. It is considered experimental, however, to use acupuncture to treat numbness and/or tingling in the feet and/or hands that is related to chemotherapy.
Up to 30 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
- Conditions
- Lymphoma, Myeloma, Peripheral Neuropathy
- Being tested
- Acupuncture
- Keywords
- Lymphoma, Myeloma, Multiple Myeloma, MM, Non-Hodgkin's Lymphoma, NHL, Acupuncture, Treatment-induced Peripheral Neuropathy, Thalidomide, Bortezomib, Neuropathy, Peripheral Neuropathy
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell, Peripheral Nervous System Diseases, Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).
Measured: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2013
- Study completionApr 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Wang, MD, BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891618
- Sponsor's protocol ID
- 2006-0679
- Status last verified
- Sep 2016
- First submitted
- 30 Apr 2009
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Garcia MK, Cohen L, Guo Y, Zhou Y, You B, Chiang J, Orlowski RZ, Weber D, Shah J, Alexanian R, Thomas S, Romaguera J, Zhang L, Badillo M, Chen Y, Wei Q, Lee R, Delasalle K, Green V, Wang M. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol. 2014 May 9;7:41. doi: 10.1186/1756-8722-7-41.
PubMed 24886772
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
- ClinicalTrials.gov ID
- NCT00891618
- Acronym / sponsor ID
- 2006-0679
- Conditions
- Lymphoma, Myeloma, Peripheral Neuropathy
- Keywords
- Lymphoma, Myeloma, Multiple Myeloma, MM, Non-Hodgkin's Lymphoma, NHL, Acupuncture, Treatment-induced Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Apr 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy.
Detailed description
Acupuncture:
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. In this study, the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Acupuncture Sessions:
Your first acupuncture session will be on the same day as the tests described above, if possible. (If not, it will be scheduled for another day that will be no more than about 10 days after the screening visit.)
You will have an acupuncture session 3 times per week for 4 weeks (Weeks 1-4). You will then have 1 week off (Week 5). After that, you will have an acupuncture session twice per week for 4 more weeks (Weeks 6-10). This is a total of 20 sessions. In addition to the 20 planned sessions, you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body where the needles will be placed. All study participants will have the needles placed at the same points on the body (the hands, feet, legs, abdomen, and scalp).
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures. The needles will remain in place for about 20-30 minutes.
Electrical stimulation will be added to some of the needles on the feet and hands. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level for you.
Study Procedures:
At each session, before you receive the acupuncture, the following procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may be experiencing.
- The color and coating of your tongue and the quality of your pulse will be recorded.
Once a week, you will also be asked to complete the same 3 questionnaires as you did at the beginning of the study.
Most study visits will last about 1 hour. On the weeks that you complete the questionnaires, it may add about 15-20 minutes.
During the study, you may still receive your regular pain treatments. If you are receiving Neurontin (gabapentin), Cymbalta (duloxetine), and/or Lyrica (pregabalin), you must stay on the same drug(s) until you go off this study. Minor changes in the doses of your pain treatments are allowed, but if there is a large change, you will be taken off study early.
Length of Study Participation:
You may receive up to 21 acupuncture sessions over 13 weeks. If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
At Week 13, or if you go off study early for any reason, you will have an end-of-study visit. If the doctor thinks it is necessary, the following procedures will be performed:
- Your medical history will be recorded.
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have experienced.
- You will complete the same 3 questionnaires as before.
- The 4 nerve tests will be repeated in order to learn if there have been any changes in your nerve function.
- Your tongue and pulse will be evaluated.
After the end-of-study visit, your participation in this study will be over.
This is an investigational study. The acupuncture needles used in this study are commercially available and FDA approved. It is considered experimental, however, to use acupuncture to treat numbness and/or tingling in the feet and/or hands that is related to chemotherapy.
Up to 30 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients, or the legal guardians of patients, must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- Age > 18 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed. Patients will be removed from the study if a change in type of medication is necessary. All patients will receive treatment to both upper and lower extremities, regardless of whether or not they are experiencing symptoms in all four extremities.)
- The patient's previous chemotherapy treatment must have included thalidomide and/or bortezomib and/or any derivatives.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
Key exclusion criteria (16 listed)
- Current active treatment with thalidomide and/or bortezomib.
- 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 infection.)
- Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and anticoagulation agents.
- Known coagulopathy and taking heparin (including low molecular weight heparin) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories will be 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 |
|---|---|---|
| Acupuncture3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes. | Other | Acupuncture |
Primary outcome
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Time frame: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.
Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24886772Garcia MK, Cohen L, Guo Y, Zhou Y, You B, Chiang J, Orlowski RZ, Weber D, Shah J, Alexanian R, Thomas S, Romaguera J, Zhang L, Badillo M, Chen Y, Wei Q, Lee R, Delasalle K, Green V, Wang M. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol. 2014 May 9;7:41. doi: 10.1186/1756-8722-7-41.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Michael Wang, MD, BS principal investigator
UT MD Anderson Cancer Center
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 Lymphoma and Myeloma, run by M.D. Anderson Cancer Center at 1 site 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 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: finished, as of the sponsor's last update on 31 Oct 2016. 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 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. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2016). 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?
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment) (time frame: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.). 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 NCT00891618, 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 31 Oct 2016.