Recruiting

Electro Acupuncture

Sponsor:

University of Manitoba

Code:

NCT02821442

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Sham Acupuncture

Study Details

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

Study ID

NCT02821442

Start date

Feb, 2016

Status verified date

Jun, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acupuncture

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).

sham comparator: Sham Acupuncture

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.

Interventions

Acupuncture

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

Sham Acupuncture

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

Primary outcome measure

  • S-Lanss (short- Leads assessment of neuropathic symptoms and signs) [ Time Frame: 2 years ]
  • VAS (Visual Analogue Scale) [ Time Frame: 2 years ]
  • DASH (Disabilities of the arm, shoulder, hand) [ Time Frame: 2 years ]
  • LEFS (Lower extremity functional scale) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Elizabeth Hammond, M.Sc.

204-451-5702umande20@myumanitoba.ca

Barbara Shay, PhD

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

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0T6

Contacts

Barbara Shay, PhD

204 977 5636Barbara.Shay@med.umanitoba.ca

Principal Investigator:

Barbara L Shay, PhD

More Information

Sponsor

University of Manitoba

Last update posted

Jan 26, 2018

Last verified

Jun, 2017

Keywords

  • Electroacupuncture
  • Neuropathic Pain
  • Chemotherapy Induced Peripheral Neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2018-01-26.