International multicentric randomized controlled trial of acupuncture in the treatment of hot flashes in hormone-receptor-positive breast cancer

Phase 1

Recruiting

• Conditions: Hot flashes in a patient with hormone receptor positive breast cancer

• Registration Number: ITMCTR2100004791
• Lead Sponsor: Jiangsu Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
2. Premenopausal or postmenopausal status;
3. Post chemotherapy (if administered) and surgery;
4. Currently undergoing adjuvant hormonal therapy (eg. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at the study entry;
5. 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;
6. Aged >= 18 years;
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
8. Signed informed consent.

Exclusion Criteria

1. Currently undergoing chemotherapy or radiation or have surgery planned during protocol period;
2. Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
3. Uncontrolled seizure disorder or history of seizure;
4. Active clinically significant uncontrolled infection;
5. Use of acupuncture for hot flashes within 6 months prior to the study entry;
6. Uncontrolled major psychiatric disorders, such as major depression or psychosis;
7. 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast cancer function scale;Endocrine subscale for breast cancer;Daily of hectic fever;Pittsburgh Sleep Quality Rating Scale;