Study Stopped
The study Principal Investigator relocated and the grant funding the trial expired.
Acupuncture for Lymphedema Secondary to Breast Cancer Treatment
Rehabilitation of Breast Cancer Treatment Related Lymphedema Using Electro-acupuncture: A Randomized Controlled Trial
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 14, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 30, 2017
August 1, 2017
2.8 years
May 14, 2014
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in amount of arm tissue water determined by Bioimpedance Analysis
Bioimpedance analysis devices take readings using 8 electrode pads that are placed on top of the skin of the arms. The electrode pads are connected to a computer that transmits a small amount of electrical current between the electrode pads. The process of taking readings takes less than 1 minute and is painless (participants may not be able to feel it working).
Before and after a 20 minute period at a single scheduled appointment
Secondary Outcomes (3)
Change in dermal concentration of red blood cells in the arm assessed using light polarization spectroscopy
Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes
Change in arm circumference
Before and after a 20 minute period at a single scheduled appointment
Lymphedema Questionnaire
Administered at a single screening visit and 2 week follow up
Other Outcomes (2)
Baseline current perception threshold
Readings are taken once during a 15 minute during a single screening visit
Baseline arm tissue water determined by Bioimpedance Analysis
Readings are taken once during a 15 minute screening visit
Study Arms (2)
Acupuncture + Electrical Stimulation
EXPERIMENTALAcupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes.
Control
NO INTERVENTIONParticipants who are randomized to receive no intervention will still receive physical assessment.
Interventions
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).
Eligibility Criteria
You may qualify if:
- \>1yr following the conclusion of breast cancer treatment
- Lymphedema of the upper limb: unilateral (one-side)
You may not qualify if:
- History or evidence of hormone-receptor positive cancer
- Previous nodal dissection or radiotherapy to other regions
- Contraindications for acupuncture or electrical stimulation
- Pre-cancer or bi-lateral lymphedema
- Evidence of active cancer
- History of contralateral cancer, radiation or surgery
- Edema of the neck/midline/torso
- Pregnancy
- Allergies to nickel, chromium, or silicon
- Seizures (epilepsy)
- Tremors (shakiness) that may interfere with treatment
- Infections, scarring, open wounds, or broken skin at needle sites
- Infections, open wounds, or broken skin on the upper limbs (electrode \& landmark sites)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8S 4L8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek Rosa, PhD(c)
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
June 9, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2017
Study Completion
December 1, 2017
Last Updated
August 30, 2017
Record last verified: 2017-08