Breast CancerAcupunctureNCT02803736
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
A study testing acupuncture in people with Breast Cancer and Lymphedema, run by Fourth Affiliated Hospital of Guangxi Medical University.
Trial summary
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Breast Cancer, Lymphedema, Acupuncture
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women who completed all primary and adjuvant treatments.
- age between 20 and 45.
- BMI between 18 and 28.
- unilateral lymphedema resulting from surgery for breast cancer.
- mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
- with no evidence of recurrence.
Who cannot join
- bilateral lymphedema.
- history of bilateral axillary lymph node dissection.
- serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
- pregnant women.
- unable to adhere to the protocol or the treatment schedule.
- recurrent breast cancer or other malignancies.
- current use of chemotherapy or radiation.
- current use of diuretic drugs like Diosmin, or other investigational drugs.
Trial locations and contacts
No sites are listed yet.
About this study
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.
Read the detailed description
In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.
- Conditions
- Breast Cancer, Lymphedema, Acupuncture
- Being tested
- acupuncture
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called zhen jiu
Acupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Real acupuncture group | Experimental | Patients in the real acupuncture group will receive true acupuncture 3 times a week for 4 weeks (12 sessions). A standardized prescription of six acupuncture points is used unilaterally. Needles are inserted and manipulated manually until needling sensation (de qi) is obtained, and are retained for 20 minutes with manual manipulation at 10 minutes. Acupuncturists are trained to inquire about specific needle sensations when providing true acupuncture. Receives: Device: acupuncture |
| Sham acupuncture group | Sham comparator | Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions). Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Reduced Limb Volume Ratio
Data of the absolute limb volume will be collected before the treatment (volume at baseline, B) and after the treatment (volume after therapy, A) for every participant. VL is the volume of the affected arm with lymphedema, and VC is the volume of the contralateral arm. Then, The ARLVR will be calculated using the following formula: ARLVR (%) = (VL-Vc)B-( VL-Vc)A/( VL-Vc)B ×100%.
The arm measurement will be conducted using perometer. This method is inspired by the method established by Anderson et al.
Measured: Day 0 (baseline), Day 30(endpoint)
Secondary outcomes (1)
Incidence of Adverse Event
Every adverse event during the treatment will be recorded, unless it is confirmed otherwise, whereas those occurs after the treatment will not be calculate unless it is confirmed.
Measured: Day 0 (baseline), Day 30(endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Wei, Principal investigator, Guangxi Medical University Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803736
- Sponsor's protocol ID
- PJK201690
- Acronym
- Acupuncture
- Status last verified
- Nov 2016
- First submitted
- 14 Jun 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
PubMed 10987238Zhu H, Li J, Peng Z, Huang Y, Lv X, Song L, Zhou G, Lin S, Chen J, He B, Qin F, Liu X, Dai M, Zou Y, Dai S. Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial. BMC Complement Altern Med. 2017 Sep 21;17(1):467. doi: 10.1186/s12906-017-1980-0.
PubMed 28934950
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT02803736
- Acronym / sponsor ID
- Acupuncture / PJK201690
- Conditions
- Breast Cancer, Lymphedema, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital
- Study start
- Dec 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Jun 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.
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.
Detailed description
In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real acupuncture group | Experimental | Device: acupuncturePatients in the real acupuncture group will receive true acupuncture 3 times a week for 4 weeks (12 sessions). A standardized prescription of six acupuncture points is used unilaterally. Needles are inserted and manipulated manually until needling sensation (de qi) is obtained, and are retained for 20 minutes with manual manipulation at 10 minutes. Acupuncturists are trained to inquire about specific needle sensations when providing true acupuncture. |
| Sham acupuncture group | Sham comparator | Device: acupuncturePatients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women who completed all primary and adjuvant treatments.
- age between 20 and 45.
- BMI between 18 and 28.
- unilateral lymphedema resulting from surgery for breast cancer.
- mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
Key exclusion criteria (8 listed)
- bilateral lymphedema.
- history of bilateral axillary lymph node dissection.
- serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
- pregnant women.
- unable to adhere to the protocol or the treatment schedule.
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 |
|---|---|---|
| acupunctureAlso: zhen jiuAcupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow. | Device | Real acupuncture group, Sham acupuncture group |
Primary outcome
Absolute Reduced Limb Volume Ratio
Time frame: Day 0 (baseline), Day 30(endpoint)
Data of the absolute limb volume will be collected before the treatment (volume at baseline, B) and after the treatment (volume after therapy, A) for every participant. VL is the volume of the affected arm with lymphedema, and VC is the volume of the contralateral arm. Then, The ARLVR will be calculated using the following formula: ARLVR (%) = (VL-Vc)B-( VL-Vc)A/( VL-Vc)B ×100%. The arm measurement will be conducted using perometer. This method is inspired by the method established by Anderson et al.
1 secondary outcome
Incidence of Adverse Event
Time frame: Day 0 (baseline), Day 30(endpoint)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Background: PubMed 10987238Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
- Derived from this study: PubMed 28934950Zhu H, Li J, Peng Z, Huang Y, Lv X, Song L, Zhou G, Lin S, Chen J, He B, Qin F, Liu X, Dai M, Zou Y, Dai S. Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial. BMC Complement Altern Med. 2017 Sep 21;17(1):467. doi: 10.1186/s12906-017-1980-0.
- Individual participant dataSharing planned: Undecided
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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.
Xiangcheng Wei principal investigator
Guangxi Medical University Institutional Review Board
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Breast Cancer and Lymphedema, run by Fourth Affiliated Hospital of Guangxi Medical University.
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 6 inclusion and 8 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Zheng Peng (+86 772 3840144, 1371@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Reduced Limb Volume Ratio (time frame: Day 0 (baseline), Day 30(endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803736, which also lists 2 linked publications.
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 23 Nov 2016.