1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma

NCT01541644 | Completed Results DMC

• 2 other identifiers: HP-00047788GCC 1068
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Neuropathies; Multiple Myeloma

Keywords

Acupuncture Therapy; bortezomib-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Baseline and 10 weeks

Study Arms (1)

Acupuncture

EXPERIMENTAL

All participants will receive acupuncture treatments over a total of 10 weeks.

Device: Acupuncture

Interventions

Acupuncture DEVICE

Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Multiple Myeloma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

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.

Results Point of Contact

• Title: Emily Parks
• Organization: University of Maryland Baltimore Greenebaum Cancer Center

eparks@umm.edu

410-328-7340

Study Officials

• Ting Bao, MD, DABMA

  University of Maryland Marlene & Stewart Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 1, 2012
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2014
• Last Updated: November 7, 2019
• Results First Posted: March 11, 2016

Record last verified: 2019-11

Locations

US (1)