Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Acupuncture, Breast Cancer
Eligibility 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
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
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
Outcomes
Primary Outcome Measures
Incidence of Treatment-related Adverse Events (Safety)
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)
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
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
State-Trait Anxiety Inventory (STAI) score will be collected at 4 time points during each cycle.
Full Information
NCT ID
NCT03170648
First Posted
May 23, 2017
Last Updated
February 6, 2023
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03170648
Brief Title
Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
Official Title
Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Acupuncture, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Treatment-related Adverse Events (Safety)
Description
Incidence of Treatment-related Adverse Events will be assessed by CTCAE v4.0 during chemotherapy infusion
Time Frame
From starting chemotherapy infusion up to 5 days of post-infusion
Title
The numbers of study patients being recruited and retained (Feasibility)
Description
The numbers of study patients being recruited and retained during the study period will be documented as planned
Time Frame
from the activation of the study to the completion of the recruitment, 6 months.
Secondary Outcome Measure Information:
Title
Changes in Edmonton Symptom Assessment System (ESAS) score relative to Baseline
Description
Edmonton Symptom Assessment System (ESAS) Total Score will be collected at 4 time points during each cycle
Time Frame
from baseline to Day 5 after chemotherapy infusion
Title
Changes in State-Trait Anxiety Inventory (STAI) score relative to Baseline
Description
State-Trait Anxiety Inventory (STAI) score will be collected at 4 time points during each cycle.
Time Frame
from baseline to Day 5 after chemotherapy infusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Lu, MB, MPH, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35238615
Citation
Yang E, Lu W, Giobbie-Hurder A, Shin IH, Chen WY, Block CC, Partridge A, Jeselsohn RM, Tolaney SM, Freedman RA, Ligibel JA. Auricular Acupuncture During Chemotherapy Infusion in Breast Cancer Patients: A Feasibility Study. J Integr Complement Med. 2022 May;28(5):427-435. doi: 10.1089/jicm.2021.0256. Epub 2022 Mar 2.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35238615/
Description
PubMed link
Learn more about this trial
Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
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