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

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

Tracking Information

• First Submitted Date: December 19, 2018
• First Posted Date: December 21, 2018
• Last Update Posted Date: March 19, 2024
• Actual Study Start Date: January 15, 2019
• Actual Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2018): Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10 [ Time Frame: 10 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 19, 2018)

• Response Rate [ Time Frame: 10 weeks ]
• Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer [ Time Frame: 2 years ]
• Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale [ Time Frame: 2 years ]
• Pittsburgh Sleep Quality Index [ Time Frame: 2 years ]
• Changes in plasma proinflammatory cytokines [ Time Frame: 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
• Official Title: Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Breast Cancer

Intervention

• 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
• Other: Usual Care
  the current standard of care with non-hormonal pharmacotherapy of western medicine

Study Arms

• 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.
  Intervention: Device: Acupuncture
• 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
  Intervention: Other: Usual Care

• Publications *: Baedorf Kassis S, Lu W, White SA, Shin IH, Park SH, Jeong YJ, Yao C, Ligibel J, Bierer BE. Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial. BMC Complement Med Ther. 2022 Jun 17;22(1):161. doi: 10.1186/s12906-022-03648-4.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 19, 2018): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2024
• Actual Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03783546
• Other Study ID Numbers: 18-371
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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].

• Current Responsible Party: Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: The Comprehensive and Integrative Medicine Institute of South Korea

Investigators

• Principal Investigator: Weidong Lu, PhD, MPH; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: March 2024