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

NCT03783546 | Completed Results FDA Device

• 1 other identifier: 18-371
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10

  Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.

  10 weeks

Secondary Outcomes (2)

• Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer

  10 weeks

• Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)

  10 weeks

Study Arms (2)

Immediate Acupuncture

EXPERIMENTAL

* 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

Delayed acupuncture

ACTIVE COMPARATOR

* 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

Interventions

Acupuncture DEVICE

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

Immediate Acupuncture

Usual Care OTHER

the current standard of care with non-hormonal pharmacotherapy of western medicine

Delayed acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• The Comprehensive and Integrative Medicine Institute of South Korea: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 35715806 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

We randomized patients to immediate acupuncture vs. delayed acupuncture rather than using an active control condition. This raises the possibility that the placebo effect could have contributed to the impact of the immediate acupuncture intervention on hot flashes.

Results Point of Contact

• Title: Weidong Lu, MB, MPh, PhD
• Organization: Dana-Farber Cancer Institute

weidong_lu@dfci.harvard.edu

617-632-3322

Study Officials

• Weidong Lu, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: January 15, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 9, 2026
• Results First Posted: July 18, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to: \[contact information for Sponsor- Investigator or designee\].

Locations

US (1)