Chemotherapy-induced Peripheral NeuropathyNCT04770402
Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients
A study testing Acupuncture in people with Chemotherapy-induced Peripheral Neuropathy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized, controlled trial is designed to evaluate the effect of acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN), other symptoms, and potential opioid and concomitant medication sparing effects in comparison to standard of care management in Multiple Myeloma subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 6 Apr 2023
- Phase
- Interventional
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent
- Subject has diagnosis of Multiple Myeloma (any stage) per Investigator
- Currently being treated with bortezomib or bortezomib-combination chemotherapy
- ECOG Performance status of 0-3
- Life expectancy of ≥ 12 weeks
Show all 9Show fewer
- Chemotherapy-Induced Peripheral Neuropathy score of ≥ 2
- No planned hospital admission in the next 10 weeks
- As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
Who cannot join
- Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
- Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures
- Subjects with needle phobia
- Previous diagnosis of amyloidosis or POEMS syndrome
- Local infection at or near the planned acupuncture sites (see Appendix A)
- Subjects with metastatic involvement of the nervous system/active central nervous system disease
- Plan to receive Healing Touch or Oncology Massage during study
- Have received acupuncture within 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial
This randomized, controlled trial is designed to evaluate the effect of acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN), other symptoms, and potential opioid and concomitant medication sparing effects in comparison to standard of care management in Multiple Myeloma subjects.
Read the detailed description
This study aims to strengthen the care of persons with Multiple Myeloma by improving quality of life (QOL) and ability to perform daily activities through reduced Chemotherapy-Induced Peripheral Neuropathy (CIPN) symptoms. CIPN debilitates and erodes QOL by preventing individuals from pursuing their normal activities of daily living.
The features of CIPN, including physical, social/family, emotional, functional, and specific CIPN symptoms, will be measured with the validated FACT-GOG-NTX. This project brings necessary attention and scientific inquiry to supportive cancer care, which is sometimes de-prioritized behind disease treatment. The potential for nonpharmacologic acupuncture to reduce CIPN and other symptoms with minimal side effects has beneficial implications for disease treatment. Patients with controlled symptoms are better able to tolerate life-prolonging treatment and avoid chemotherapy dose reductions which result from neurotoxic side effects of chemotherapy.
Subjects who consent and are determined to be eligible will be randomized to receive either acupuncture treatment or standard of care treatment for their CIPN. Subjects' socio-demographics, medical history, opioid and concomitant medication intake information will be collected. Subjects who are randomized to the acupuncture treatment arm will receive 12 sessions of acupuncture over approximately 10 weeks. Subjects randomized to standard of care will continue with standard of care therapy per their physician for treatment of their CIPN. All subjects will complete questionnaires at Baseline, mid-point, and endpoint. Responses to questionnaires will then be analyzed towards answering the study's objectives.
- Being tested
- Acupuncture, Standard of Care CIPN management
- Keywords
- Neuropathy, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
12 acupuncture sessions over 10 weeks
Standard of Care CIPN managementOther
Investigator directed standard of care management of CIPN
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Subjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician. Receives: Other: Acupuncture |
| Standard of Care | Active comparator | Subjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy. Receives: Other: Standard of Care CIPN management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.
Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week.
Measured: Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.
Secondary outcomes (11)
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX
Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome
Measured: 10 weeks
Nausea - FACT-GOG-NTX
Nausea will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP2 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have nausea.'
Measured: approx. 10 weeks
Sadness- FACT-GOG-NTX
Sadness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel sad'.
Measured: approx. 10 weeks
Nervousness- FACT-GOG-NTX
Nervousness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel nervous.'
Measured: approx. 10 weeks
Sleep Quality- FACT-GOG-NTX
Sleep quality will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GF5 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I am sleeping well.'
Measured: approx. 10 weeks
Lack of Energy- FACT-GOG-NTX
Lack of energy will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have a lack of energy.'
Measured: approx. 10 weeks
Pain- FACT-GOG-NTX
Pain will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have pain.'
Measured: approx. 10 weeks
Constipation
Constipation will be determined for each subject as a 5-level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have constipation.'
Measured: approx. 10 weeks
Dizziness
Dizziness will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dizziness'.
Measured: approx. 10 weeks
Dry Mouth
Dry mouth will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dry mouth.'
Measured: approx. 10 weeks
General Health - CDC-HRQOL
General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.
Measured: approx. 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start15 Sep 2021
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Low accrual
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 Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Shamille Hariharan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770402
- Sponsor's protocol ID
- IRB00081364
- Other IDs
- 00049444, LCI-SUPP-MYE-ACUP-001
- Status last verified
- Dec 2024
- First submitted
- 22 Feb 2021
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04770402
- Acronym / sponsor ID
- IRB00081364
- Keywords
- Neuropathy, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, controlled trial is designed to evaluate the effect of acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN), other symptoms, and potential opioid and concomitant medication sparing effects in comparison to standard of care management in Multiple Myeloma subjects.
Detailed description
This study aims to strengthen the care of persons with Multiple Myeloma by improving quality of life (QOL) and ability to perform daily activities through reduced Chemotherapy-Induced Peripheral Neuropathy (CIPN) symptoms. CIPN debilitates and erodes QOL by preventing individuals from pursuing their normal activities of daily living.
The features of CIPN, including physical, social/family, emotional, functional, and specific CIPN symptoms, will be measured with the validated FACT-GOG-NTX. This project brings necessary attention and scientific inquiry to supportive cancer care, which is sometimes de-prioritized behind disease treatment. The potential for nonpharmacologic acupuncture to reduce CIPN and other symptoms with minimal side effects has beneficial implications for disease treatment. Patients with controlled symptoms are better able to tolerate life-prolonging treatment and avoid chemotherapy dose reductions which result from neurotoxic side effects of chemotherapy.
Subjects who consent and are determined to be eligible will be randomized to receive either acupuncture treatment or standard of care treatment for their CIPN. Subjects' socio-demographics, medical history, opioid and concomitant medication intake information will be collected. Subjects who are randomized to the acupuncture treatment arm will receive 12 sessions of acupuncture over approximately 10 weeks. Subjects randomized to standard of care will continue with standard of care therapy per their physician for treatment of their CIPN. All subjects will complete questionnaires at Baseline, mid-point, and endpoint. Responses to questionnaires will then be analyzed towards answering the study's objectives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureSubjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician. |
| Standard of Care | Active comparator | Other: Standard of Care CIPN managementSubjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent
- Subject has diagnosis of Multiple Myeloma (any stage) per Investigator
- Currently being treated with bortezomib or bortezomib-combination chemotherapy
- ECOG Performance status of 0-3
Key exclusion criteria (8 listed)
- Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
- Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures
- Subjects with needle phobia
- Previous diagnosis of amyloidosis or POEMS syndrome
- Local infection at or near the planned acupuncture sites (see Appendix A)
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 |
|---|---|---|
| Acupuncture12 acupuncture sessions over 10 weeks | Other | Acupuncture |
| Standard of Care CIPN managementInvestigator directed standard of care management of CIPN | Other | Standard of Care |
Primary outcome
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.
Time frame: Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.
Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week.
11 secondary outcomes
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX
Time frame: 10 weeks
Nausea - FACT-GOG-NTX
Time frame: approx. 10 weeks
Sadness- FACT-GOG-NTX
Time frame: approx. 10 weeks
Nervousness- FACT-GOG-NTX
Time frame: approx. 10 weeks
Sleep Quality- FACT-GOG-NTX
Time frame: approx. 10 weeks
Lack of Energy- FACT-GOG-NTX
Time frame: approx. 10 weeks
Pain- FACT-GOG-NTX
Time frame: approx. 10 weeks
Constipation
Time frame: approx. 10 weeks
Dizziness
Time frame: approx. 10 weeks
Dry Mouth
Time frame: approx. 10 weeks
General Health - CDC-HRQOL
Time frame: approx. 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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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.
Shamille Hariharan, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chemotherapy-induced Peripheral Neuropathy, run by Wake Forest University Health Sciences 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 9 inclusion and 8 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 27 Jan 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). 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?
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management. (time frame: Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.). 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 27 Jan 2025.