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A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Peripheral Neuropathies, Multiple Myeloma

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Trial Information

A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome 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).

Outcome Description:

Response is defined as the average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks as compared to baseline. Effect is defined as as the 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.

Outcome Time Frame:

Week 10

Safety Issue:

Yes

Principal Investigator

Ting Bao, MD, DABMA

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

HP-00047788

NCT ID:

NCT01541644

Start Date:

May 2011

Completion Date:

March 2013

Related Keywords:

  • Peripheral Neuropathies
  • Multiple Myeloma
  • Acupuncture Therapy
  • bortezomib-induced peripheral neuropathy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

University of Maryland Marlene & Stewart Greenebaum Cancer CenterBaltimore, Maryland  21201