Breast CancerNCT02821442
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
A study testing Acupuncture in people with Breast Cancer, run by University of Manitoba at 1 site in Canada.
Trial summary
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.
Who cannot join
- Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
- patients with heart valve replacements
- patients on prophylactic antibiotics
- patients with severe coagulopathy
- patients who did not receive regular taxane therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0T6
Barbara Shay, PhD, 204 977 5636, Barbara.Shay@med.umanitoba.ca
Barbara L Shay, PhD
About this study
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior
Read the detailed description
A double blind prospective randomized controlled pilot study with cross over.
To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.
Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.
Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients
Sham AcupunctureDevice
Placebo needles appear to penetrate but do not actually penetrate the skin
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA). Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on. Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
Measured: 2 years
VAS (Visual Analogue Scale)
10 point verbal rating pain scale to measure participants pain in each assessment
Measured: 2 years
DASH (Disabilities of the arm, shoulder, hand)
30 item questionnaire measuring upper limb function
Measured: 2 years
LEFS (Lower extremity functional scale)
20 item questionnaire measuring lower limb function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- CancerCare Manitoba
- Responsible party
- Principal investigator, Barbara Shay, University of Manitoba
- Investigators
- Barbara Shay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821442
- Sponsor's protocol ID
- H2015:282
- Status last verified
- Jun 2017
- First submitted
- 8 Dec 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
- ClinicalTrials.gov ID
- NCT02821442
- Acronym / sponsor ID
- H2015:282
- Conditions
- Breast Cancer
- Keywords
- Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- CancerCare Manitoba
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Jul 2016 (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.
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior
Detailed description
A double blind prospective randomized controlled pilot study with cross over.
To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.
Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.
Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureAcupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA). |
| Sham Acupuncture | Sham comparator | Device: Sham AcupunctureSham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.
Key exclusion criteria (5 listed)
- Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
- patients with heart valve replacements
- patients on prophylactic antibiotics
- patients with severe coagulopathy
- patients who did not receive regular taxane therapy
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 |
|---|---|---|
| AcupunctureAcupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients | Device | Acupuncture |
| Sham AcupuncturePlacebo needles appear to penetrate but do not actually penetrate the skin | Device | Sham Acupuncture |
Primary outcome
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
Time frame: 2 years
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
VAS (Visual Analogue Scale)
Time frame: 2 years
10 point verbal rating pain scale to measure participants pain in each assessment
DASH (Disabilities of the arm, shoulder, hand)
Time frame: 2 years
30 item questionnaire measuring upper limb function
LEFS (Lower extremity functional scale)
Time frame: 2 years
20 item questionnaire measuring lower limb function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Yes
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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.
Barbara Shay, PhD principal investigator
University of Manitoba
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 in people with Breast Cancer, run by University of Manitoba 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Hammond, M.Sc. (204-451-5702, umande20@myumanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-Lanss (short- Leads assessment of neuropathic symptoms and signs) (time frame: 2 years). The study lists 4 primary outcomes in all. 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 26 Jan 2018.