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

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01541644
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 43
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathies; Multiple Myeloma	Device: Acupuncture	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture All participants will receive acupuncture treatments over a total of 10 weeks.	Device: Acupuncture; Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Outcome Measures

Primary Outcome Measures

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) [Baseline and 10 weeks]

   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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Marlene & Stewart Greenebaum Cancer Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Ting Bao, MD, DABMA, University of Maryland Marlene & Stewart Greenebaum Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01541644
• Other Study ID Numbers: HP-00047788; GCC 1068
• First Posted: Mar 1, 2012
• Last Update Posted: Nov 7, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by University of Maryland, Baltimore: Acupuncture Therapy; bortezomib-induced peripheral neuropathy
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Peripheral Nervous System Diseases

Study Results

Participant Flow

Arm/Group Title	Acupuncture
Arm/Group Description	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.
Period Title: Overall Study
STARTED	27
COMPLETED	24
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Acupuncture
Arm/Group Description	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.
Overall Participants	27
Age, Customized (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63
Sex: Female, Male (Count of Participants)
Female	13 48.1%
Male	14 51.9%
Region of Enrollment (participants) [Number]
United States	27 100%

Outcome Measures

1. Primary Outcome

Title	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)
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.
Time Frame	Baseline and 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture
Arm/Group Description	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.
Measure Participants	27
Mean (Standard Deviation) [units on a scale (1 - 100)]	13.3 (6.5)

Adverse Events

Time Frame	9 months
Arm/Group Title	Acupuncture
Arm/Group Description	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.
All Cause Mortality
	Acupuncture
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Acupuncture
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	Acupuncture
	Affected / at Risk (%)	# Events
Total	0/27 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.