"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"

NCT02821442 | Unknown

• 1 other identifier: H2015:282
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior

Conditions

Breast Cancer

Keywords

Electroacupuncture; Neuropathic Pain; Chemotherapy Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (4)

• S-Lanss (short- Leads assessment of neuropathic symptoms and signs)

  16 point pain questionnaire that differentiates nociceptive from neuropathic pain

  2 years

• VAS (Visual Analogue Scale)

  10 point verbal rating pain scale to measure participants pain in each assessment

  2 years

• DASH (Disabilities of the arm, shoulder, hand)

  30 item questionnaire measuring upper limb function

  2 years

• LEFS (Lower extremity functional scale)

  20 item questionnaire measuring lower limb function

  2 years

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA).

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on.

Device: Sham Acupuncture

Interventions

Acupuncture DEVICE

Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients

Acupuncture

Sham Acupuncture DEVICE

Placebo needles appear to penetrate but do not actually penetrate the skin

Sham Acupuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.

You may not qualify if:

• Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
• patients with heart valve replacements
• patients on prophylactic antibiotics
• patients with severe coagulopathy
• patients who did not receive regular taxane therapy

Sponsors & Collaborators

• University of Manitoba: lead
• CancerCare Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Barbara Shay, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Hammond, M.Sc.

CONTACT

204-451-5702; umande20@myumanitoba.ca

Barbara Shay, PhD

CONTACT

204-977-5636; barbara.shay@med.umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department head, College of Rehabilitation Sciences

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: July 1, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 26, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)