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The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. If eligible to take part in this study, participants will be randomly assigned to 1 of 2 groups - group 1 participants will receive traditional acupuncture treatments 2 times a week for a total of 20 sessions. Group 2 participants will have acupuncture sessions with electrical stimulation 2 times a week for a total of 20 sessions.
Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Peripheral neuropathy often causes weakness, numbness and pain, usually in the hands and feet. It can also affect other areas of the body. People with peripheral neuropathy generally describe the pain as stabbing, burning or tingling.
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Research has shown that acupuncture can reduce symptoms of pain and nausea by altering pain signaling along nerves. The effect of acupuncture can be enhanced by additional movement of the needles called manual acupuncture, which involves rotating the needle and moving it up and down. Another type of acupuncture is called electro-acupuncture, which involves running a low level electrical current between two needle points. Preliminary studies indicate that acupuncture may also be helpful to treat chemotherapy related neuropathy. This trial will determine the relative effects of both manual acupuncture and electro-acupuncture for treating chronic chemotherapy-induced neuropathy.
Participants will be assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual acupuncture | Experimental | Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points. |
|
| Electro-acupuncture | Experimental | Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points with additional application of weak electrical stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture | Other | Manual acupuncture twice a week for 20 treatments. Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion rate | Percent of participants that complete the treatment protocol, with completions being defined as receiving at least 20 acupuncture treatments within 2 weeks of the scheduled course of treatments (Which is 12 weeks). | Up to 12 weeks from start of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific, health-related quality of life as measured by FACT-G | Cancer-specific, health-related quality of life as measured by Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire. The range of scores lies on a spectrum of 0 - 108, with higher scores indicating better quality of life. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lee, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Participants will be randomly assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
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A research assistant blind to group assignment will distribute and collect the results of the FACT/GOG-Ntx subscale, FACT-G, TNSc, NPS, QST, GPT, Unipedal Stance balance test, and medication use per the study calendar. In addition, data about the subject's past medical history including cancer details and relevant medical conditions (e.g., diabetes mellitus and peripheral vascular disease) will be collected. This data will not be seen by the acupuncturists while the subject is receiving treatment.
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| Electro-acupuncture | Other | Electro-acupuncture twice a week for 20 treatments. Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes. Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied. |
|
| Peripheral neuropathy or neuropathy as measured by (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-Ntx) | The Ntx subscale is an 11-item questionnaire to assess neurotoxic effects of chemotherapy with scores ranging on a scale of 11-44. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Quality of life as measured by Total Neuropathy Score - Clinically Based (TNSc) | The Total Neuropathy Score - Clinically Based (TNSc) scale is a 10-item scale assessing chemotherapy-induced peripheral neuropathy with scores ranging on a scale of 0-44. Higher scores indicate worse symptoms. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Quality of life as measured by Neuropathy Pain Scale (NPS) | The Neuropathy Pain Scale (NPS) is a 10-item scale assessing neuropathic pain with scores ranging on a scale of 0-100. Higher scores indicate worse symptoms. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Change in participant's ability to detect thermal sensory stimuli as measured by Quantitative Sensory Testing (QST) | Threshold detection of thermal sensory stimuli as measured by Quantitative Sensory Testing (QST) to assess change in participant's ability to detect thermal sensory stimuli. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Change in participant's ability to detect vibration sensory stimuli as measured by Quantitative Sensory Testing (QST) | Threshold detection of vibration sensory stimuli as measured by Quantitative Sensory Testing (QST) to assess change in participant's ability to detect vibration sensory stimuli. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Change in hand function as measured by Grooved Pegboard Test (GPT) | Times the ability of subjects to complete insertion of 25 shaped pegs and is a surrogate for hand function. Subjects will be asked to complete the GPT twice and the time will be averaged for each assessment time point. An increasing time to complete the task would indicate worsening hand function due to neuropathy symptoms. Change in time taken to complete task will be reported. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Change in balance as measured by Unipedal Stance balance test | Participants will perform a unipedal stance with eyes open for a goal of 45 seconds and will be allowed a total of 3 trials to achieve the 45 seconds with the highest time recorded. A decreasing time of unipedal stance would indicate worsening balance due to neuropathy symptoms. Change in time will be reported. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |
| Use of neuropathic and pain medications | Change in number of medications after treatment (decrease in medications being positive change). These medications may include NSAIDS, acetaminophen, opioid medications (e.g., morphine, oxycodone), amitriptyline, neurontin, pregabalin, carbamezapine, or other related medications. | At 2, 4, 6, 8, 10, and 14 weeks after start of treatment. |