Clinical trial · Interventional
Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
NCT05613504CI-TRIAL-00062199not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study intends to further evaluate the efficacy of acupuncture by comparing the intervention effects of different acupuncture treatment regimens on hot flashes in breast cancer ; and to explore the central effect regulation mechanism of acupuncture intervention on hot flashes based on integrated PET/MRI technology.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture treatment | Other | — | UNRESOLVED |
| Sham acupuncture treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Treatment group A
- description
- Treatment group A was given endocrine and acupuncture treatment for 8 weeks (24 times in total, 3 times a week); followed up for 16 weeks, no acupuncture treatment.
- interventionNames
- Other: Acupuncture treatment
- type
- SHAM_COMPARATOR
- label
- Treatment group B
- description
- Treatment group B was given endocrine and sham acupuncture treatment for 8 weeks, followed up for 16 weeks, no acupuncture during the period, and after 16 weeks, received standardized acupuncture for 8 weeks (24 times in total, 3 times a week).
- interventionNames
- Other: Sham acupuncture treatment
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 30-75 years old; * Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment; * Patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4; * Patients after surgery and chemotherapy (if any); * Eastern Cooperative Oncology Group score of 0-1 points. * Sign the informed consent and participate in the clinical observation voluntarily. Exclusion Criteria: * Tumor metastases, undergoing chemoradiotherapy or planning surgery; * Pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4 weeks prior to study initiation; * Patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines; * Started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks, pregnant or breastfeeding patients; * Bleeding or coagulation disorders with obvious uncontrolled infection * Psychiatric illness or family history; neurological disorder or family history; seizure possibility or history of seizures.
References
Publications (0)
Data not yet available
No reference posted for this study.