- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158832
Acupuncture for Lymphedema Secondary to Breast Cancer Treatment
Rehabilitation of Breast Cancer Treatment Related Lymphedema Using Electro-acupuncture: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be invited to attend a 30-60 minute screening visit to determine eligibility. This screening visit will be located at a laboratory at McMaster University's Institute of Applied Health Sciences. Eligibility will be determined using health questionnaires and non-invasive physical assessment of the upper limbs. Participants may not be eligible for further participation based on their health status and risks to health and safety.
Participants meeting eligibility criteria will be invited to 1 scheduled appointment (30-60 minutes in duration). The appointment time will be scheduled according to individual symptoms, such that it will coincide with the time of day that lymphedema symptoms are predicted to be at their highest. Upon arrival at the scheduled appointment, participants will be randomized to receive 20 minutes of acupuncture+applied electrical stimulation or no treatment. Participants in both groups will be asked to provide physical assessment data over a period of 30 minutes during the scheduled appointment. Differences between groups in tissue swelling of the affected upper-limb will be determined immediately following treatment, and at 10 minutes following treatment.
Participants will be asked to report any significant changes to their health state for a period of 2 weeks following treatment. A follow-up questionnaire will be made available at 2 weeks following attendance of the scheduled appointment.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >1yr following the conclusion of breast cancer treatment
- Lymphedema of the upper limb: unilateral (one-side)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture + Electrical Stimulation
Acupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes.
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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).
Other Names:
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No Intervention: Control
Participants who are randomized to receive no intervention will still receive physical assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in amount of arm tissue water determined by Bioimpedance Analysis
Time Frame: Before and after a 20 minute period at a single scheduled appointment
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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).
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Before and after a 20 minute period at a single scheduled appointment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dermal concentration of red blood cells in the arm assessed using light polarization spectroscopy
Time Frame: Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes
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A digital camera is used to 'see under the skin' and measure the amount of red blood cells in the arm.
The camera is an ordinary digital camera connected to special computer software.
Assessment using the camera is harmless and patients will not be able to feel it working.
A series of digital photographs of a small area of the arms will be taken.
The computer uses these photographs to calculate a number that represents the amount of blood contained in the skin of the arm.
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Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes
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Change in arm circumference
Time Frame: Before and after a 20 minute period at a single scheduled appointment
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Measurements are taken of both arms using a flexible measuring tape to be used in the calculation of size and volume.
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Before and after a 20 minute period at a single scheduled appointment
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Lymphedema Questionnaire
Time Frame: Administered at a single screening visit and 2 week follow up
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Survey is administered to collect data pertaining to the condition of lymphedema.
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Administered at a single screening visit and 2 week follow up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline current perception threshold
Time Frame: Readings are taken once during a 15 minute during a single screening visit
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Small electrodes will be placed on the tips of the middle finger and a weak electrical stimulus applied.
This electrical stimulus will be raised up until the point participants can feel it as a 'tingling' or 'tapping' sensation (a non-painful stimulus).
Doing so is used to assess the functioning of nerves in the affected arm.
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Readings are taken once during a 15 minute during a single screening visit
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Baseline arm tissue water determined by Bioimpedance Analysis
Time Frame: Readings are taken once during a 15 minute screening visit
|
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).
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Readings are taken once during a 15 minute screening visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Derek Rosa, PhD(c), McMaster University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIREB 14-089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphedema
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Lymphatica Medtech SATerminatedLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmSwitzerland
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Maastricht University Medical CenterRadboud University Medical Center; Erasmus Medical CenterRecruitingLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmNetherlands
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ThuasneUniversity Hospital, Tours; Delta ConsultantsCompletedLymphedema, Secondary | Lymphedema of Leg | Lymphedema Congenital | Lymphedema PrimaryFrance
-
Odense University HospitalDanish Cancer SocietyActive, not recruitingPathologic Processes | Neoplasms | Skin Diseases | Lymphatic Diseases | Postoperative Complications | Breast Cancer | Breast Diseases | Lymphedema | Breast Neoplasm | Surgery | Secondary Lymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema Arm | Iatrogenic Lymphedema | A... and other conditionsDenmark
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Swansea Bay University Health BoardSwansea University; Huntleigh Healthcare Ltd; Lymphoedema Wales Clinical NetworkCompleted
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ResMedLymphatic Solutions, LLCCompletedLymphedema | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema PrimaryUnited States
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