Breast Cancer LymphedemaNCT03373474
Warm Acupuncture for Breast Cancer Related Lymphedema
A study testing local distribution points association and local-distal points association in people with Breast Cancer Lymphedema, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- local distribution points association and local-distal points association
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2018to 26 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms.
- Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
- Karnofsky Performance Score (KPS) ≥ 70
- Men or women aged 18 to 80 years
- Out-patients
- Estimated life expectancy > 6 months
Who cannot join
- Bilateral breast cancer related lymphedema
- Taking diuretic
- History of primary lymphedema
- A diagnosis of severe heart, liver, kidney or hematologic disease
- Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
- Have hypoproteinemia
Show all 13Show fewer
- Inflammation, scar, or trauma at the site of operation, or other active skin infections
- Unable to self-care, had a history of psychological disorders, or unable to communicate
- Received lymphedema treatment within the past 1 month
- Pregnancy or breastfeeding
- The presence of electronic medical device implants
- Deny to sign the informed written consent, or unwilling to conform to randomization
- Participation in other clinical trials during the study period
Trial locations and contacts
1 site in 1 country.
China1 site
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
About this study
Official title: Comparison of Effectiveness Between Warm Acupuncture With Local-Distal Points Association and Local Distribution Points Association in Breast Cancer Related Lymphedema Patients: A Multicenter, Randomized, Controlled Clinical Trial
The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- local distribution points association, local-distal points association
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local distribution points associationOther
Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.
local-distal points associationOther
Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.
| Study group | Role | What they receive |
|---|---|---|
| local distribution points association | Experimental | Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only. Receives: Other: local distribution points association |
| local-distal points association | Experimental | Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs. Receives: Other: local-distal points association |
| waiting-list | No intervention | Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity circumference
Various assessment methods are available but circumference measure is simple, convenient with low cost, and reliable. Therefore, the primary outcome measures will be the mean change in inter-limb circumference difference from baseline to the end of the 8-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease, 10 cm above the wrist crease, elbow crease, 10 cm above the elbow crease, where the lymphedema is most severe and its corresponding location on the unaffected limb.
Measured: 80 weeks
Secondary outcomes (5)
Upper extremity volume
Volume measurement is also commonly used for the evaluation of lymphedema and the mean change in inter-limb volume difference from baseline to the end of the 8-week intervention will be included as the second primary outcome measure. The volume of the affected and unaffected limb will be measured by the volumetric measuring device (Baseline, America) using the water displacement method, which is considered as the most reliable method for volume measurements.
Measured: 80 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
Common terminology criteria for adverse events (CTCAE 4.03) will be used to grade the severity of swelling using the edema limbs criteria. A grading of mild, moderate or severe swelling will be assessed based on the inter-limb circumference or volume discrepancy, anatomic architecture, appearance, or activities of daily living. The CTCAE 4.03 will allow us to evaluate the clinical significance of circumference change.
Measured: 80 weeks
Stages of lymphedema from the international society of lymphology
Stages of lymphedema from the international society of lymphology will be used to grade the severity of lymphedema. Staging of 0, I, II, or III will be assessed based on severity of swelling, ability to reduce swelling by elevation, and skin changes.
Measured: 80 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Disabilities of the arm, shoulder, and hand (DASH) is a scale consists of two concepts: functional status (part A) and symptoms (part B) respectively. The functional status part is further divided into three dimensions: physical, social, and psychological. The total score of the DASH ranges from 0 to 100 with higher scores representing worse symptoms and function. The DASH has good validity and responsiveness and it is recommended to assess upper extremity function in breast cancer survivors. The validated Chinese version of the DASH will be used in this study.
Measured: 80 weeks
The MOS 36-Item Short-Form Health Survey (SF-36)
The medical outcome study 36-item short-form health survey (SF-36) is a commonly used instrument to assess quality of life that has good validity. The SF-36 includes the following eight concepts: physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perception. The validated Chinese version of the SF-36 will be used in this study.
Measured: 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start18 Jan 2018
- Primary completion26 May 2020
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemaStudies 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
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Basic Research Program, China, Tianjin Medical University Cancer Institute and Hospital, The Second Affiliated Hospital of Baotou Medical College, Henan Provincial People's Hospital, Qilu Hospital of Shandong University, Sichuan Cancer Hospital and Research Institute
- Responsible party
- Principal investigator, Yi Guo, Tianjin University of Traditional Chinese Medicine
- Investigators
- XingFang Pan, Principal investigator, Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373474
- Sponsor's protocol ID
- 2014CB543202-02
- Status last verified
- Apr 2021
- First submitted
- 7 Dec 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeh CH, Zhao TY, Zhao MD, Wu Y, Guo YM, Pan ZY, Dong RW, Chen B, Wang B, Wen JR, Li D, Guo Y, Pan XF. Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2019 Jul 5;20(1):403. doi: 10.1186/s13063-019-3491-4.
PubMed 31277678
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness Between Warm Acupuncture With Local-Distal Points Association and Local Distribution Points Association in Breast Cancer Related Lymphedema Patients: A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03373474
- Acronym / sponsor ID
- 2014CB543202-02
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- National Basic Research Program, China, Tianjin Medical University Cancer Institute and Hospital, The Second Affiliated Hospital of Baotou Medical College, Henan Provincial People's Hospital, Qilu Hospital of Shandong University, Sichuan Cancer Hospital and Research Institute
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 14 Dec 2017 (actual)
- 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.
The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| local distribution points association | Experimental | Other: local distribution points associationParticipants will receive warm acupuncture with the local distribution acupoints association on the affected arm only. |
| local-distal points association | Experimental | Other: local-distal points associationParticipants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs. |
| waiting-list | No intervention | –Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms.
- Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
- Karnofsky Performance Score (KPS) ≥ 70
- Men or women aged 18 to 80 years
- Out-patients
Key exclusion criteria (13 listed)
- Bilateral breast cancer related lymphedema
- Taking diuretic
- History of primary lymphedema
- A diagnosis of severe heart, liver, kidney or hematologic disease
- Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
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 |
|---|---|---|
| local distribution points associationParticipants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm. | Other | local distribution points association |
| local-distal points associationParticipants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9. | Other | local-distal points association |
Primary outcome
Upper extremity circumference
Time frame: 80 weeks
Various assessment methods are available but circumference measure is simple, convenient with low cost, and reliable. Therefore, the primary outcome measures will be the mean change in inter-limb circumference difference from baseline to the end of the 8-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease, 10 cm above the wrist crease, elbow crease, 10 cm above the elbow crease, where the lymphedema is most severe and its corresponding location on the unaffected limb.
5 secondary outcomes
Upper extremity volume
Time frame: 80 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
Time frame: 80 weeks
Stages of lymphedema from the international society of lymphology
Time frame: 80 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time frame: 80 weeks
The MOS 36-Item Short-Form Health Survey (SF-36)
Time frame: 80 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 31277678Yeh CH, Zhao TY, Zhao MD, Wu Y, Guo YM, Pan ZY, Dong RW, Chen B, Wang B, Wen JR, Li D, Guo Y, Pan XF. Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2019 Jul 5;20(1):403. doi: 10.1186/s13063-019-3491-4.
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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.
XingFang Pan principal investigator
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local distribution points association and local-distal points association in people with Breast Cancer Lymphedema, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
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 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: finished, as of the sponsor's last update on 6 May 2021. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Upper extremity circumference (time frame: 80 weeks). 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 NCT03373474, which also lists 1 linked publication.
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 6 May 2021.