Overview

This trial is active, not recruiting.

Conditions peripheral neuropathies, multiple myeloma
Treatment acupuncture
Sponsor University of Maryland
Start date May 2011
End date June 2012
Trial size 25 participants
Trial identifier NCT01541644, GCC 1068, HP-00047788

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
All participants will receive acupuncture treatments over a total of 10 weeks.
acupuncture
Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Primary Outcomes

Measure
To determine the response rate, effectiveness and safety of acupuncture in alleviating neuropathic symptoms when treating patients with moderate to severe Bortezomib-induced Peripheral Neuropathy (BIPN).
time frame: Week 10

Secondary Outcomes

Measure
To assess if acupuncture treatment is associated with reduced oral analgesic use in patients with BIPN.
time frame: Week 14
To assess if acupuncture treatment is associated with changes in neurologic examination and nerve conduction studies.
time frame: Week 14
To explore the mechanisms of acupuncture in treating BIPN by studying the changes in proinflammatory cytokines and beta endorphins.
time frame: Week 14
To determine if the study's acupuncture schedule is feasible in treating multiple myeloma patients with BIPN.
time frame: Week 2

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients
Principal investigator Ting Bao, MD, DABMA
Description Information gained from this clinical trial will provide insight into the efficacy and mechanism of acupuncture in reducing Bortezomib-induced Peripheral Neuropathy (BIPN) in multiple myeloma patients. It will examine the effect of acupuncture on serum proinflammatory cytokine and β-endorphin levels to further understand the mechanism of acupuncture on a molecular level. This study is the first clinical trial studying the effect of acupuncture on treating BIPN. It is also the first study to explore the mechanism of acupuncture through frequent small amount of blood draws at six time points to detect changes in proinflammatory cytokines and β-endorphins. It has the potential to identify a minimal risk non-pharmacological intervention to alleviate BIPN symptoms, and to significantly improve our understanding of the mechanism of acupuncture.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Maryland.