Clinical trial · Interventional
1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients are asked to be in this study if they have multiple myeloma and are having tingling, numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with multiple myeloma often take bortezomib (velcade®). This research is being done to find out if acupuncture can reduce the nerve pain, tingling, and/or numbness patients experience due to bortezomib (velcade®). Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be used to ease nerve pain and tingling, numbness that is caused by bortezomib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Peripheral Neuropathies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acupuncture
- description
- All participants will receive acupuncture treatments over a total of 10 weeks.
- interventionNames
- Device: Acupuncture
Primary outcomes (1)
- measure
- To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)
- timeFrame
- Baseline and 10 weeks
- description
- The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians \& the TNSc in our trial was performed by a research nurse. The reliability \& validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of multiple myeloma. * Greater than or equal to grade 2 BIPN as defined by the National Cancer Institute - -Common Toxicity Criteria (NCI-CTC) 4.0. * BIPN symptoms persist after bortezomib has been discontinued. * Eastern Cooperative Oncology Group (ECOG) performance status 0-3. * Men and women who are ≥ 18 years old * The patient is aware of the nature of his or her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. Exclusion Criteria: * Prior acupuncture within the past month. * Life expectancy is \< 3 months. * Plan to go on experimental drug for multiple myeloma that is known to cause peripheral neuropathy in the next 14 weeks. * Concomitant treatment with chemotherapy, unless approval is given by the Principal Investigator.
References
Publications (0)
Data not yet available