Clinical trial NCT02158832: Acupuncture for Lymphedema Secondary to Breast Cancer Treatment
Official title: Rehabilitation of Breast Cancer Treatment Related Lymphedema Using Electro-acupuncture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphedema
Keywords: Lymphoedema
Edema
Oedema
Cancer
Breast Cancer
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
name: Holistic Health Research Foundation of Canada
First posted: 2014-06-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in amount of arm tissue water determined by Bioimpedance Analysis
timeFrame: Before and after a 20 minute period at a single scheduled appointment
Secondary outcomes:
measure: Change in dermal concentration of red blood cells in the arm assessed using light polarization spectroscopy
timeFrame: Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes
measure: Change in arm circumference
timeFrame: Before and after a 20 minute period at a single scheduled appointment
measure: Lymphedema Questionnaire
timeFrame: Administered at a single screening visit and 2 week follow up
Other outcomes:
measure: Baseline current perception threshold
timeFrame: Readings are taken once during a 15 minute during a single screening visit
measure: Baseline arm tissue water determined by Bioimpedance Analysis
timeFrame: Readings are taken once during a 15 minute screening visit
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Derek Rosa, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: