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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01466 | Registry Identifier | NCI CTRP |
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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 neuropathy in cancer patients.
Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
Study Visits Before the First Acupuncture Session:
You will return to the clinic about 7-10 days after the screening visit. The following tests will be performed 2 times over a 1-2 week span:
A series of tests used to check your nerve function will also be performed. In total, it should take about 1-2 hours to complete these 4 tests. The following nerve function tests will be performed:
Acupuncture Sessions:
At each session, before you receive the acupuncture, your tongue checked and your heart rate will be measured.
Your first acupuncture session may be on the same day as some of the tests described above, if possible. If not, it will be scheduled for another day no more than 14 days after the screening visit, unless you are in Group 3.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body where the needles will be placed. All study participants will have the needles placed at the same points on the body (the hands, feet, legs, abdomen, and scalp).
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures. The needles will remain in place for about 20 minutes.
Electrical stimulation will be added to some of the needles on your feet and hands. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level for you.
Most acupuncture sessions will last about 1 hour. On the weeks that you complete the questionnaires, it will add about 15-20 minutes.
After your 6th and 12th acupuncture sessions, you will complete the same 3 questionnaires as you did at the beginning of the study.
Length of Study:
You may take part in this study for up to 28 weeks. If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
At the end of the study, or if you go off study early for any reason, you will have an end-of-study visit. If the doctor thinks it is needed, the following procedures will be performed within 4 weeks after your last acupuncture session:
Additional Information:
During the study, you may still receive your regular pain treatments. You should tell the study doctor if you want to change your dose or want to start any new drugs for the treatment of your neuropathy.
If you were in Group 2 or 3, after your participation on this study is complete, you may receive 3 extra acupuncture treatments.
This is an investigational study. The acupuncture needles used in this study are commercially available and FDA approved. It is considered investigational to use acupuncture to treat peripheral neuropathy related to chemotherapy.
Up to 120 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Acupuncture With Electrical Stimulation | Experimental | Participants in Group 1 have acupuncture sessions with electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, take a 2 week break. After that, participant randomly assigned to receive 12 sessions of acupuncture with electrical stimulation as before or not have anymore sessions in this study. Nerve function tests performed at visit before acupuncture and at end of study visit. These tests consist of hand tasks and balance tests. Questionnaires completed at baseline, visit before acupuncture, after 6 and 12 acupuncture visits, and at end of study visit. |
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| Group 2 - Acupuncture Sessions Without Electrical Stimulation | Experimental | Participants in Group 2 have acupuncture sessions without electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, will take a 2 week break. After that, participant randomly assigned to receive 12 extra sessions of acupuncture without electrical stimulation or not have anymore sessions in this study. Nerve function tests performed at visit before acupuncture and at end of study visit. These tests consist of hand tasks and balance tests. Questionnaires completed at baseline, visit before acupuncture, after 6 and 12 acupuncture visits, and at end of study visit. |
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| Group 3 - Waitlist Group | Active Comparator | Participants in Group 3 have acupuncture sessions 3 times per week over 4 weeks for a total of 12 sessions. Participant may or may not have electrical stimulation at these sessions. These sessions will begin 14 weeks after enrollment. Nerve function tests performed at visit before acupuncture and at end of study visit. These tests consist of hand tasks and balance tests. Questionnaires completed at baseline, visit before acupuncture, after 6 and 12 acupuncture visits, and at end of study visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Group 1: Acupuncture sessions with electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, take a 2 week break. After that, participant randomly assigned to receive 12 sessions of acupuncture with electrical stimulation as before or not have anymore sessions in this study. Group 2: Acupuncture sessions without electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, will take a 2 week break. After that, participant randomly assigned to receive 12 extra sessions of acupuncture without electrical stimulation or not have anymore sessions in this study. Group 3: Acupuncture sessions 3 times per week over 4 weeks for a total of 12 sessions. Participant may or may not have electrical stimulation at these sessions. These sessions will begin 14 weeks after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Acupuncture With or Without Electrical Stimulation | Difference in scores compared from baseline to 24 treatments between the two groups with or without electrical stimulations using two-sample t-test. Difference between baseline and 24 treatments assessed in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores separately for each of the 2 acupuncture schedules using a paired t test. | After 24 acupuncture treatments |
| Difference in Acupuncture Response | Effect of 12 versus 24 acupuncture treatments examined for symptoms of chronic, chemotherapy-induced peripheral neuropathy in cancer patients and survivors. Efficacy analysis estimated using average difference between 12-week assessment and 24-week assessment in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) scale for each acupuncture schedule using a paired t test. Response difference examined between 12 versus 24 acupuncture treatments using analysis of variance including the two treatment schedules and the indicator of receiving electrical stimulation as the factors, and considering the interaction between the two factors. | After 12 and 24 acupuncture treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Symptom Scores | Symptom scores of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) scale compared between the waitlist control and the acupuncture treatment groups at week 14 after randomization compared using two-sample t-test or Wilcoxon rank-sum test. | 14 weeks after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T. Lee, MD | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| Nerve Function Tests | Procedure | Nerve function tests consisting of hand tasks and balance evaluation performed at visit before acupuncture, and at end of study visit. |
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| Questionnaires | Behavioral | Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit. |
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| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |