Clinical Trials /

Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

NCT03881748

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Suspended

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
  • Official Title: A Randomized Phase II Pilot Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial IDs

  • ORG STUDY ID: CASE4Y18
  • NCT ID: NCT03881748

Conditions

  • Peripheral Neuropathy

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Manual acupunctureExperimentalInsertion of very thin, solid, sterile, stainless steel needles into the skin at specific points.
    Electro-acupunctureExperimentalInsertion of very thin, solid, sterile, stainless steel needles into the skin at specific points with additional application of weak electrical stimulation

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Participants must have the ability to understand English, sign a written informed
                   consent document, and be willing to follow protocol requirements.
      
                -  History of a diagnosis of cancer, verifiable through documentation in a medical
                   record.
      
                -  Participants must have neuropathy ≥1 according to CTCAE v 4.0 scale or a neuropathy
                   score of >3 on a 0-10 scale despite previous treatment, which may include Neurontin,
                   Cymbalta and/or Lyrica.
      
                -  The participant'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.
      
                -  More than 6 months since last treatment
      
                -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
      
                -  Willingness to comply with all study interventions of acupuncture and follow-up
                   assessments.
      
              Exclusion Criteria:
      
                -  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
                   bortezomib chemotherapy within the past 6 months.
      
                -  Local infection at or near the acupuncture site. (Although acupuncture is a minimally
                   invasive procedure, participants 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. Participants
                   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.
      
                -  White Blood Cells (WBCs) < 3.0 K/UL or absolute neutrophil count (ANC) <1,500 K/UL) in
                   the past 30 days.
      
                -  Active Central Nervous System (CNS) disease. (The action for acupuncture may be
                   associated with central nervous system activity, and participants with CNS pathology
                   may respond differently to treatment than the general population.)
      
                -  Implanted electrical device such as cardiac pacemaker, insulin pump, or pain pump.
      
                -  Mental incapacitation or significant emotional or psychological disorder that, in the
                   opinion of the investigators, precludes study entry. (These participants 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, neuropathy related to HIV, or other medical causes of
                   chronic neuropathy in the baseline assessment including past medical history, any
                   history of diabetes, alcoholism, and vitamin B.
      
                -  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
                   chemotherapy-induced peripheral neuropathy (CIPN). New medications for the treatment
                   of CIPN are not allowed during the study. Subjects need to be on stable doses of CIPN
                   medications for 4 weeks.
      
                -  Grade III lymphedema or lymphedema considered severe by the treating clinician
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Treatment completion rate
      Time Frame:Up to 12 weeks from start of study.
      Safety Issue:
      Description: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).

      Secondary Outcome Measures

      Measure:Cancer-specific, health-related quality of life as measured by FACT-G
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Peripheral neuropathy or neuropathy as measured by (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-Ntx)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description:The Ntx subscale is an 11-item questionnaire to assess neurotoxic effects of chemotherapy with scores ranging on a scale of 11-44.
      Measure:Quality of life as measured by Total Neuropathy Score - Clinically Based (TNSc)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Quality of life as measured by Neuropathy Pain Scale (NPS)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Change in participant's ability to detect thermal sensory stimuli as measured by Quantitative Sensory Testing (QST)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Change in participant's ability to detect vibration sensory stimuli as measured by Quantitative Sensory Testing (QST)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Change in hand function as measured by Grooved Pegboard Test (GPT)
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Change in balance as measured by Unipedal Stance balance test
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.
      Measure:Use of neuropathic and pain medications
      Time Frame:At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
      Safety Issue:
      Description: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.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Case Comprehensive Cancer Center

      Trial Keywords

      • Acupuncture

      Last Updated

      November 8, 2019