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SINF: Peripheral Neuropathy in Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168894
Recruitment Status : Withdrawn
First Posted : June 20, 2014
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Procedure: Acupuncture Procedure: Nerve Function Tests Behavioral: Questionnaires Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Acupuncture for the Treatment of Chronic, Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - Acupuncture With Electrical Stimulation
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.
Procedure: Acupuncture

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.


Procedure: Nerve Function Tests
Nerve function tests consisting of hand tasks and balance evaluation performed at visit before acupuncture, and at end of study visit.

Behavioral: Questionnaires
Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit.
Other Name: Surveys

Experimental: Group 2 - Acupuncture Sessions Without Electrical Stimulation
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.
Procedure: Acupuncture

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.


Procedure: Nerve Function Tests
Nerve function tests consisting of hand tasks and balance evaluation performed at visit before acupuncture, and at end of study visit.

Behavioral: Questionnaires
Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit.
Other Name: Surveys

Active Comparator: Group 3 - Waitlist Group
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.
Procedure: Acupuncture

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.


Procedure: Nerve Function Tests
Nerve function tests consisting of hand tasks and balance evaluation performed at visit before acupuncture, and at end of study visit.

Behavioral: Questionnaires
Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit.
Other Name: Surveys




Primary Outcome Measures :
  1. Efficacy of Acupuncture With or Without Electrical Stimulation [ Time Frame: After 24 acupuncture treatments ]
    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.

  2. Difference in Acupuncture Response [ Time Frame: After 12 and 24 acupuncture treatments ]
    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.


Secondary Outcome Measures :
  1. Comparison of Symptom Scores [ Time Frame: 14 weeks after randomization ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have the ability to understand English, Mandarin, or Taiwanese.
  2. Sign a written informed consent document.
  3. Willing to follow protocol requirements.
  4. Age 18 and older.
  5. History of diagnosis of cancer.
  6. Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients will be removed from the study if a change in type of medication is necessary. Patients are allowed to stop medications but not replace them with other medications
  7. The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team.
  8. ECOG Performance Status of 0, 1, or 2 (Appendix B).
  9. Willingness to comply with all study interventions of acupuncture and follow-up assessments.

Exclusion Criteria:

  1. Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
  2. Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
  3. Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
  4. Physical deformities that could interfere with accurate acupuncture point location.
  5. Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals.
  6. Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
  7. Platelets < 50 H K/UL in the past 30 days.
  8. WBCs < 3.0 K/UL or ANC <1,500 K/UL) in the past 30 days.
  9. Active CNS disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
  10. Cardiac pacemaker.
  11. Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
  12. Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
  13. History of diabetic neuropathy or neuropathy related to HIV.
  14. Previous acupuncture treatment for any indication within 30 days of enrollment.
  15. Planned or actual changes in type of medications that could affect symptoms related to PN. New medications for the treatment of CIPN are not allowed during the study. Note: Subjects need to be on stable doses of CIPN medications for 4 weeks.
  16. Grade III lymphedema or lymphedema considered severe by the treating clinician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168894


Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Richard T. Lee, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02168894    
Other Study ID Numbers: 2013-0930
NCI-2014-01466 ( Registry Identifier: NCI CTRP )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by M.D. Anderson Cancer Center:
Peripheral neuropathy
Chemotherapy-Induced Peripheral Neuropathy
Cancer Survivors
Acupuncture
Electrical stimulation
Nerve function tests
Hand function tests
Balance tests
Questionnaires
Surveys
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases