NCT03540251

Clinical Study on Auricular Points Sticking Plus Chinese Medication for Hot Flashes in Breast Cancer Women

Auricular Points Sticking for the Treatment of Hot Flashes in Breast Cancer Patients, a Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Longhua Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Object:The aim of this study was to investigate the effectiveness of sticking and massaging auricular points for the management of hot flashes in postoperative breast cancer patients.

Detailed description

Patients and Methods A randomized controlled trial is conducted by comparing effectiveness of sticking and massaging auricular points relieving hot flashes in women with breast cancer versus placebo auricular points. A total of 92 women(still recuiting) with breast cancer, who were under hormonal therapy were randomly assigned and the allocation ratio was 1:1. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments. The primary outcome was hot flash score(HFS)at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes.The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric Scale(GCS)and Menopause Quality of Life scales(MenQoL)as well as serum estradiol(E2), follicle-stimulating hormone(FSH) and beta-endorphin(β-EP).Expectation and satisfaction of treatment effect and safety were also evaluated.

Conditions

• Breast Cancer
• Hormonal Therapy
• Hot Flashes
• Acupuncture

Interventions

Type	Name	Description
OTHER	Auricular Points Sticking	Auricular Points Sticking is a kind of acupunture based on Meridians Theory of traditional Chinese Medicine.Sticking and pressing predefined therapeutic auricular points can relieve the frequency and severity of hot flashes and other climacteric symptoms. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments.

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2018-05-30
• Last updated: 2019-03-05

Locations

1 site across 1 country: China