Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy

NCT02831114 | Completed

• 1 other identifier: Pro00038410
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the global use of antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the mechanisms underlying resolution of TIPN. This would provide critical validation of acupuncture and increase potential for other forms of chemotherapy induced peripheral neuropathy.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Change in taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale.

  All 18 participants will complete the PGIC scale at 6 weeks and 12 weeks. This scale will ask questions about the participants' change in activity limitations, symptoms, emotions, and overall quality of life related to their peripheral neuropathy since the beginning of treatment.

  12 Weeks

• Evaluate the mechanism of acupuncture as a treatment of TIPN through quantification of inflammatory biomarkers and circulation levels of mitochondrial DNA (mtDNA)

  Approximately 8ml of blood will be collected from each participant at baseline, 6 weeks, and 12 weeks. The samples will be collected in purple top BD vacutainers.

  12 Weeks

Secondary Outcomes (3)

• Change in quality of life using the FACT/GOG-NTX questionnaire

  12 Weeks

• Evaluate if neuropathic mechanisms are contributing to pain measured by the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale

  12 Weeks

• Change in taxane induced peripheral neuropathy related pain measured by the Brief Pain Inventory (BPI).

  12 Weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The nine participants in the intervention arm will receive 18 acupuncture treatments over the course of 12 weeks (2 treatments per week for 6 weeks and 1 treatment per week for 6 weeks). They will undergo assessments at baseline, 6 weeks, and 12 weeks through the use of questionnaires and blood tests. The participants will also be allowed to continue their conventional therapy for TIPN.

Other: Acupuncture

Control

NO INTERVENTION

The nine participants in this arm will undergo the same assessments as the intervention arm at baseline, 6 weeks, and 12 weeks. They will not receive any acupuncture treatments during this time, but will be allowed to continue their conventional therapy. The control arm will be offered the same 18 acupuncture treatments after a wait of at least 12 weeks.

Interventions

Acupuncture OTHER

Acupuncture uses tiny needles to promote blood flow, nervous system signaling, and brings the body back into homeostasis which the state of optimum functioning. Treatment for taxane induced peripheral neuropathy will consist of traditional acupuncture and will use points located in the foot (SP 3, ST 41, LR 3, K 3, GB 41), knee (SP 9, ST 36, K 10, GB 34), and arm (LI 11). Participants will continue to take their conventional therapy. Each acupuncture treatment will take place at Oriental Medicine Associates with trained acupuncturist, William Hendry. Each session should last about 30 minutes.

Intervention

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III)
• Completed active chemotherapeutic with taxane therapy (taxotere, Taxol, Abraxane) within the last 24 months
• Established diagnosis of motor and sensory neuropathy greater or equal to 2 according to the CTCAE v 4.03 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica
• Read, understand, and speak English

You may not qualify if:

• Currently undergoing active treatment with chemotherapy (not including TKI's or other targeted therapy)
• Any acupuncture treatment for any indication within the 30 days of enrollment
• Cardiac Pacemaker
• Deformities that interfere with accurate acupuncture point locations
• Local infection at or near the acupuncture site
• Pregnant or currently lactating
• Medical History of chronic alcohol use
• Mental incapacitation or significant emotional or psychological disorder

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship

Greenville, South Carolina, 29605, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Mark A O'Rourke, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

• Renee J LeClair, PhD

  University of South Carolina School of Medicine, Greenville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: July 13, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 4, 2018

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)