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Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study

This study is not yet open for participant recruitment.
Verified June 2017 by Weidong Lu, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03170648
First Posted: May 31, 2017
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Weidong Lu, Dana-Farber Cancer Institute
  Purpose
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.

Condition Intervention
Breast Cancer Device: Acupuncture

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Weidong Lu, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Incidence of Treatment-related Adverse Events (Safety) [ Time Frame: From starting chemotherapy infusion up to 5 days of post-infusion ]
    Incidence of Treatment-related Adverse Events will be assessed by CTCAE v4.0 during chemotherapy infusion

  • The numbers of study patients being recruited and retained (Feasibility) [ Time Frame: from the activation of the study to the completion of the recruitment, 6 months. ]
    The numbers of study patients being recruited and retained during the study period will be documented as planned


Secondary Outcome Measures:
  • Changes in Edmonton Symptom Assessment System (ESAS) score relative to Baseline [ Time Frame: from baseline to Day 5 after chemotherapy infusion ]
    Edmonton Symptom Assessment System (ESAS) Total Score will be collected at 4 time points during each cycle

  • Changes in State-Trait Anxiety Inventory (STAI) score relative to Baseline [ Time Frame: from baseline to Day 5 after chemotherapy infusion ]
    State-Trait Anxiety Inventory (STAI) score will be collected at 4 time points during each cycle.


Estimated Enrollment: 25
Anticipated Study Start Date: June 19, 2017
Estimated Study Completion Date: May 31, 2023
Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Patients will receive a 30-minute session of a standardized ear acupuncture treatment Acupuncture needles will be gently manipulated to increase stimulation For each ear acupuncture session, the patient will have ear acupuncture therapy administered to each ear
Device: Acupuncture
Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea

Detailed Description:

Chemotherapy drugs used to treat cancer can cause many symptoms. Some of the most common symptoms of receiving chemotherapy are nausea, vomiting, and anxiety. These symptoms can affect the quality of life of cancer patients. Medications can help ease these, but many patients continue to experience symptoms despite these treatments.

Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea.

Ear acupuncture is a type of acupuncture that involves the stimulation of points on the external ear. A few studies have suggested that ear acupuncture may help to reduce symptoms of nausea and anxiety during chemotherapy.

This study is being done to evaluate the potential benefits of using ear acupuncture to reduce symptoms like nausea and anxiety for women receiving chemotherapy for breast cancer.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically or cytologically proven Stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Signed informed consent

Exclusion Criteria:

  • Receiving weekly chemotherapy
  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
  • Uncontrolled seizure disorder
  • Pregnancy or potential pregnancy
  • Active clinically significant uncontrolled infection
  • Prior use of acupuncture within 3 months prior to the study entry
  • Uncontrolled major psychiatric disorders, such as major depression or psychosis
  • Metastatic breast or other cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170648


Contacts
Contact: Weidong Lu, MB, MPH, PhD 617-632-4350 Weidong_Lu@dfci.harvard.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Weidong Lu, MB, MPH, PhD    617-632-3988    Weidong_Lu@dfci.harvard.edu   
Principal Investigator: Weidong Lu, MB, MPH, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Weidong Lu, MB, MPH, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Weidong Lu, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03170648     History of Changes
Other Study ID Numbers: 17-065
First Submitted: May 23, 2017
First Posted: May 31, 2017
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Weidong Lu, Dana-Farber Cancer Institute:
Acupuncture
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases