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Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized Controlled Clinical Trial

Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019644
Enrollment
Unknown
Registered
2018-11-20
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Breast cancer

Interventions

Observation group:Combining therapy with traditional Chinese Medicine-Based psychotherapy and herbal medicines

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary breast cancer (stage 0-III) by pathologic diagnosis and with menopausal symptoms; 2. Aged 25-60 years old; 3. Patients are undergoing endocrine therapy for more than 3 months; 4. The subjects experienced at least 4 times of moderate and severe hot flashes every day; 5. The Karnofsky score is greater than or equal to 60 points; 6. The predicted survival time is greater than or equal to 6 months; 7. Voluntarily sign the informed consent file.

Exclusion criteria

Exclusion criteria: 1. Patients with recurrent, metastatic breast cancer or other cancer diagnosed by imaging or histology 2. Patients who cannot adhere to endocrine therapy; 3. Uncontrolled and/or diagnosed medical conditions such as severe liver, kidney, heart, and brain diseases; abnormal bone marrow function; Uncontrolled or untreated hypertension (SBP >160mmHg and/or DBP > 100mmHg), Uncontrolled or untreated diabetes; Or abnormal thyrotropin may lead to symptoms similar to menopausal symptoms. 4. Pregnant and lactating women; 5. Participated in phase I and II clinical trials in the past 6 months or participated in phase III and IV clinical trials in 3 months; 6. Use other medications (e.g. tibolone, black cohosh extract or soy isoflavones, vitamins, etc.) for menopausal symptoms within 3 months; 7. Allergic to the tested drug.

Design outcomes

Primary

MeasureTime frame
Greene Scale;

Secondary

MeasureTime frame
HFRDIS;QLQ-BR23;

Countries

China

Contacts

Public ContactJIAN LIU

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

jianliu@gzucm.edu.cn+86 15802034064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026