N/A
Completed N=27
1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
Peripheral Neuropathies · Multiple Myeloma
Source: ClinicalTrials.gov NCT01541644 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: 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) — 13.3 units on a scale (1 - 100)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
13.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01541644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.