Warm Acupuncture for Breast Cancer Related Lymphedema

April 30, 2021 updated by: Yi Guo, Tianjin University of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: local distribution points association
Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
Other: local distribution points association

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.
EXPERIMENTAL: local-distal points association
Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
Other: local-distal points association

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.
NO_INTERVENTION: waiting-list
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
80 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper extremity volume
Time Frame: 80 weeks
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.
80 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
Time Frame: 80 weeks
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.
80 weeks
Stages of lymphedema from the international society of lymphology
Time Frame: 80 weeks
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.
80 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time Frame: 80 weeks
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.
80 weeks
The MOS 36-Item Short-Form Health Survey (SF-36)
Time Frame: 80 weeks
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.
80 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Qilu Hospital of Shandong University
Tianjin Medical University Cancer Institute and Hospital
Henan Provincial People's Hospital
Sichuan Cancer Hospital and Research Institute
National Basic Research Program, China
The Second Affiliated Hospital of Baotou Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XingFang Pan, Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014CB543202-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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