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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821442
• Other study ID #: H2015:282
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2015
• Last updated: January 24, 2018
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: University of Manitoba
• Contact: Elizabeth Hammond, M.Sc.
• Phone: 204-451-5702
• Email: umande20[@]myumanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

A double blind prospective randomized controlled pilot study with cross over.

To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.

Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.

Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Peripheral Nervous System Diseases

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	CancerCare Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-Lanss (short- Leads assessment of neuropathic symptoms and signs)	16 point pain questionnaire that differentiates nociceptive from neuropathic pain	2 years
Primary	VAS (Visual Analogue Scale)	10 point verbal rating pain scale to measure participants pain in each assessment	2 years
Primary	DASH (Disabilities of the arm, shoulder, hand)	30 item questionnaire measuring upper limb function	2 years
Primary	LEFS (Lower extremity functional scale)	20 item questionnaire measuring lower limb function	2 years