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Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

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: NCT03783546
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : March 19, 2024
Sponsor:
Collaborator:
The Comprehensive and Integrative Medicine Institute of South Korea
Information provided by (Responsible Party):
Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Acupuncture Other: Usual Care Not Applicable

Detailed Description:

Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot flashes are common side effects of breast cancer treatments and can affect mood and daily life. Medications can help ease hot flashes, but many patients continue to experience symptoms despite these treatments.

Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on the skin, with the goal of affecting body's natural healing system. Acupuncture has been tested in clinical trials in cancer patients and has been shown to be helpful in treating a number of side effects of cancer treatment, such as nausea and vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to lessen hot flashes, but more information is needed about the benefits of acupuncture in breast cancer patients.

This study is being done to test whether acupuncture can help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with mediations such as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Immediate Acupuncture
  • Will receive a standardized acupuncture protocol for a 10-week period
  • 20 sessions: twice a week for 10 weeks
  • After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.
 Device: Acupuncture
Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
Active Comparator: Delayed acupuncture
  • Will receive standard usual care without acupuncture for 10 weeks
  • Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
 Other: Usual Care
the current standard of care with non-hormonal pharmacotherapy of western medicine


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10 [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 10 weeks ]
  2. Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer [ Time Frame: 2 years ]
  3. Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale [ Time Frame: 2 years ]
  4. Pittsburgh Sleep Quality Index [ Time Frame: 2 years ]
  5. Changes in plasma proinflammatory cytokines [ Time Frame: 2 years ]

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

Inclusion Criteria:

  • History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
  • Premenopausal or postmenopausal status;
  • Completed all primary chemotherapy and surgery;
  • Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
  • Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry;
  • Age ≥ 18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Signed informed consent

Exclusion Criteria:

Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;

  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
  • Uncontrolled seizure disorder or history of seizure;
  • Active clinically significant uncontrolled infection;
  • Use of acupuncture for hot flashes within 6 months prior to the study entry;
  • Uncontrolled major psychiatric disorders, such as major depression or psychosis;
  • Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study
Contacts and Locations
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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): NCT03783546


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
The Comprehensive and Integrative Medicine Institute of South Korea
Investigators
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Principal Investigator: Weidong Lu, PhD, MPH Dana-Farber Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weidong Lu, MB, MPH, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03783546    
Other Study ID Numbers: 18-371
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Hot Flashes
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases