LymphedemaNCT02158832
Acupuncture for Lymphedema Secondary to Breast Cancer Treatment
A study testing Acupuncture + Electrical Stimulation in people with Lymphedema, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Acupuncture + Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >1yr following the conclusion of breast cancer treatment
- Lymphedema of the upper limb: unilateral (one-side)
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- Acupuncture + Electrical Stimulation
- Keywords
- Lymphoedema, Edema, Oedema, Cancer, Breast Cancer
- Medical subject headings
- Lymphedema, Edema, Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture + Electrical StimulationDevice
Also called Acupuncture, Electrical Stimulation, Electro-Acupuncture
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture + Electrical Stimulation | Experimental | Acupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes. Receives: Device: Acupuncture + Electrical Stimulation |
| Control | No intervention | Participants who are randomized to receive no intervention will still receive physical assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes
Change in arm circumference
Measurements are taken of both arms using a flexible measuring tape to be used in the calculation of size and volume.
Measured: Before and after a 20 minute period at a single scheduled appointment
Lymphedema Questionnaire
Survey is administered to collect data pertaining to the condition of lymphedema.
Measured: Administered at a single screening visit and 2 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startApr 2014 (estimated)
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The study Principal Investigator relocated and the grant funding the trial expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Interdisciplinary Network Complementary & Alternative Medicine Research, Holistic Health Research Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Derek Rosa, PhD(c), Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158832
- Sponsor's protocol ID
- HIREB 14-089
- Status last verified
- Aug 2017
- First submitted
- 14 May 2014
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Breast Cancer Treatment Related Lymphedema Using Electro-acupuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02158832
- Acronym / sponsor ID
- HIREB 14-089
- Conditions
- Lymphedema
- Keywords
- Lymphoedema, Edema, Oedema, Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study Principal Investigator relocated and the grant funding the trial expired.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Interdisciplinary Network Complementary & Alternative Medicine Research, Holistic Health Research Foundation of Canada
- Study start
- Apr 2014 (estimated)
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture + Electrical Stimulation | Experimental | Device: Acupuncture + Electrical StimulationAcupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes. |
| Control | No intervention | –Participants who are randomized to receive no intervention will still receive physical assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >1yr following the conclusion of breast cancer treatment
- Lymphedema of the upper limb: unilateral (one-side)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture + Electrical StimulationAlso: Acupuncture, Electrical Stimulation, Electro-Acupuncture2 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). | Device | Acupuncture + Electrical Stimulation |
Primary outcome
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
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).
3 secondary outcomes
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
Change in arm circumference
Time frame: Before and after a 20 minute period at a single scheduled appointment
Lymphedema Questionnaire
Time frame: Administered at a single screening visit and 2 week follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Rosa, PhD(c) principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture + Electrical Stimulation in people with Lymphedema, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.