Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

NCT03881748 | Withdrawn DMC

• 1 other identifier: CASE4Y18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Peripheral Neuropathy

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Cancer-specific, health-related quality of life as measured by FACT-G

  At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.

• Peripheral neuropathy or neuropathy as measured by (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-Ntx)

  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)

  At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.

• Quality of life as measured by Neuropathy Pain Scale (NPS)

  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)

  At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.

Study Arms (2)

Manual acupuncture

EXPERIMENTAL

Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points.

Other: Manual acupuncture

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

Other: Electro-acupuncture

Interventions

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.

Manual acupuncture

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.

Electro-acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Richard Lee, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 19, 2019
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

US (1)