NCT02168894

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

June 18, 2014

Last Update Submit

March 7, 2016

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathyChemotherapy-Induced Peripheral NeuropathyCancer SurvivorsAcupunctureElectrical stimulationNerve function testsHand function testsBalance testsQuestionnairesSurveys

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Comparison of Symptom Scores

    14 weeks after randomization

Study Arms (3)

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.

Procedure: AcupunctureProcedure: Nerve Function TestsBehavioral: Questionnaires

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.

Procedure: AcupunctureProcedure: Nerve Function TestsBehavioral: Questionnaires

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.

Procedure: AcupunctureProcedure: Nerve Function TestsBehavioral: Questionnaires

Interventions

AcupuncturePROCEDURE

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.

Group 1 - Acupuncture With Electrical StimulationGroup 2 - Acupuncture Sessions Without Electrical StimulationGroup 3 - Waitlist Group
Nerve Function TestsPROCEDURE

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

Group 1 - Acupuncture With Electrical StimulationGroup 2 - Acupuncture Sessions Without Electrical StimulationGroup 3 - Waitlist Group
QuestionnairesBEHAVIORAL

Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit.

Also known as: Surveys
Group 1 - Acupuncture With Electrical StimulationGroup 2 - Acupuncture Sessions Without Electrical StimulationGroup 3 - Waitlist Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have the ability to understand English, Mandarin, or Taiwanese.
  • Sign a written informed consent document.
  • Willing to follow protocol requirements.
  • Age 18 and older.
  • History of diagnosis of cancer.
  • 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
  • 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.
  • ECOG Performance Status of 0, 1, or 2 (Appendix B).
  • Willingness to comply with all study interventions of acupuncture and follow-up assessments.

You may not qualify if:

  • 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.
  • Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
  • 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.)
  • Physical deformities that could interfere with accurate acupuncture point location.
  • Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals.
  • 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.
  • Platelets \< 50 H K/UL in the past 30 days.
  • WBCs \< 3.0 K/UL or ANC \<1,500 K/UL) in the past 30 days.
  • 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.)
  • Cardiac pacemaker.
  • 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.)
  • Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
  • History of diabetic neuropathy or neuropathy related to HIV.
  • Previous acupuncture treatment for any indication within 30 days of enrollment.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Acupuncture TherapySurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Richard T. Lee, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

March 1, 2016

Primary Completion

March 1, 2020

Last Updated

March 8, 2016

Record last verified: 2016-03