A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hot Flashes
- Sponsor
- Nanjing University of Traditional Chinese Medicine
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in cancer therapy functional assessment
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
This topic combines the theory of "unblocking the governor and warming the yang" with the important findings of modern research, that is, the important mechanism of the spine in the pathogenesis of breast cancer, and innovatively proposes the technique of unblocking the governor and treating the spine. Prospective clinical intervention research in rehabilitation, objectively evaluate the clinical efficacy, advantages and disadvantages of this technology, so as to effectively break through the current application dilemma of acupuncture and bone-setting manipulation in tumor diseases.
Investigators
Qianyan Liu
Principal Investgator
Nanjing University of Traditional Chinese Medicine
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in cancer therapy functional assessment
Time Frame: Baseline, 8, 12，24 weeks later
Cancer therapy functional assessment scores will be assessed with Cancer Therapy Functional Assessment-Breast cancer, version 4.The minimum value is 0 , and the maximum value is 185. The higher scores mean a worse outcome.
Change in acupuncture efficacy expectation assessment
Time Frame: Baseline, 8, 12，24 weeks later
Acupuncture efficacy expectation assessment scores will be assessed with acupuncture efficacy expectation assessment. The minimum value is 0 , and the maximum value is 20. The higher scores mean a better outcome.
Change of functional connectivity of whole brain
Time Frame: Baseline, 8, 12，24 weeks later
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.
Change of metabolism of glucose in the brain
Time Frame: Baseline, 8, 12，24 weeks later
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.
Change of hot flash severity
Time Frame: Baseline, 8, 12，24 weeks later
Hot flash severity will be assessed with hot flash scores each week. There are four levels of severity： Mild: Duration: Less than five minutes. Symptoms: warmth, discomfort, flushing. Moderate: Duration: Up to fifteen minutes. Symptoms: warmth in head, neck, ears, or body; tense, tight muscles; clammy skin; change in heart rate or rhythm; light sweating; dry mouth. Severe: Duration: Up to twenty minutes. Symptoms: Fever, sometimes like a crucible or burning sensation; change in heart rate or rhythm; feeling faint; headache; heavy sweating. Very severe: Duration: Up to forty-five minutes. Symptoms: boiling heat; constant sweating; trouble breathing; feeling faint, dizzy; leg cramps or feeling cramps; change in heart rate; stomach upset. The greater severity mean a worse outcome.
Secondary Outcomes
- Change in sleep(Baseline, 8, 12，24 weeks later)