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Acupuncture for Lymphedema Secondary to Breast Cancer Treatment

NCT02158832 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-08-30

No results posted yet for this study

Summary

This study is being conducted to determine if electro-acupuncture can reduce swelling of the arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted on animals suggests that such treatment might be used to improve circulation leading to reductions in swelling. Previous research in humans with lymphedema suggests that treatment may be safe to use, although results regarding its efficacy in the reduction of swelling have not yet been established.

This research will use sophisticated, non-invasive assessment methods to determine if a single session of electro-acupuncture treatment can be effective for reducing lymphedema. Results may be used to further develop our understanding of how electro-acupuncture can be used in the management of this condition. Electro-acupuncture may provide a promising complement or alternative to conventional lymphedema treatments such as compression bandaging, massage therapy or surgery.

Conditions

  • Lymphedema

Interventions

DEVICE

Acupuncture + Electrical Stimulation

2 acupuncture needles are inserted into the upper back. 10Hz, 0.5ms biphasic square wave electrical pulses are applied to needles x20 mins. Current \>sensation threshold \& maintained at a level that is comfortable/painless \& does not elicit skeletal muscle contractions (\~5mA, \<10mA). Needle locations are in the vicinity of nerves that supply the affected upper limb: EX-B1': Affected hemisphere, 1.5cm lateral to C5 spinous process. Insertion angle: shallow, 'inferior-lateral', \~15⁰ perpendicular to the skin, \~15⁰ lateral to the midline. Depth: \~1.5 cm (secure anchorage). EX-HN15': Affected hemisphere, 1.5cm lateral to the C7 spinous process. Insertion angle: shallow, 'inferior-medial' \~15⁰ perpendicular to the skin, \~15⁰ medial. Depth: \~1.5 cm (secure anchorage).

Sponsors & Collaborators

  • Canadian Interdisciplinary Network Complementary & Alternative Medicine Research

    collaborator OTHER

  • Holistic Health Research Foundation of Canada

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Derek Rosa, PhD(c) · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-01-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158832 on ClinicalTrials.gov