Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03170648|
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|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|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2023|
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
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
- 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
- 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.
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
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Weidong Lu, MB, MPH, PhD||Dana-Farber Cancer Institute|