Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GCC 1068 | Other Identifier | University of Maryland Greenebaum Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | All participants will receive acupuncture treatments over a total of 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ting Bao, MD, DABMA | University of Maryland Marlene & Stewart Greenebaum Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Marlene & Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale (1 - 100) | Baseline and 10 weeks |
|
|
|
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | 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. | 0 | 27 | 0 | 27 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Parks | University of Maryland Baltimore Greenebaum Cancer Center | 410-328-7340 | eparks@umm.edu |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided