Back to resultsStudy of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Primary Purpose
Hot Flashes, Breast Cancer, Acupuncture
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture treatment
Sham acupuncture treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring breast cancer, Acupuncture, Integrated PET/MRI technology, Hot flashes
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.
Sites / Locations
- Jiangsu Province Hospital of Traditional Chinese Medcine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Treatment group A
Treatment group B
control
Arm 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.
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).
The control group was given conventional adjuvant endocrine therapy, premenopausal patients received tamoxifen therapy, and postmenopausal patients received aromatase inhibitor or tamoxifen therapy.
Outcomes
Primary Outcome Measures
Change in cancer therapy functional assessment
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
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
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.
Change of metabolism of glucose in the brain
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.
Change of hot flash severity
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 Outcome Measures
Change in sleep
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
Full Information
NCT ID
NCT05613504
First Posted
November 6, 2022
Last Updated
November 11, 2022
Sponsor
Nanjing University of Traditional Chinese Medicine
Collaborators
Health Science Center of Xi'an Jiaotong University, Hanzhong Hospital of Traditional Chinese Medicine, Xiang'an Hospital of Xiamen University, Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05613504
Brief Title
Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Official Title
A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine
Collaborators
Health Science Center of Xi'an Jiaotong University, Hanzhong Hospital of Traditional Chinese Medicine, Xiang'an Hospital of Xiamen University, Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Breast Cancer, Acupuncture
Keywords
breast cancer, Acupuncture, Integrated PET/MRI technology, Hot flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Active Comparator
Arm 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.
Arm Title
Treatment group B
Arm Type
Sham Comparator
Arm 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).
Arm Title
control
Arm Type
No Intervention
Arm Description
The control group was given conventional adjuvant endocrine therapy, premenopausal patients received tamoxifen therapy, and postmenopausal patients received aromatase inhibitor or tamoxifen therapy.
Intervention Type
Other
Intervention Name(s)
Acupuncture treatment
Intervention Description
Acupoint selection: 4 general points + syndrome differentiation acupoints (select or replace 2-4 acupoints according to symptom 1, select 1-2 acupoints according to symptom 2 and symptom 3), and adjust acupoints according to symptoms every week.
Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment.
Operation: Use a one-time sterile acupuncture needle (0.30×40mm, Huatuo brand), insert the needle 0.5 inch along the anatomical position, level up and relieve the qi, and keep the needle for 20 minutes.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture treatment
Intervention Description
Acupoint selection: According to the selected acupoints of the electroacupuncture group, 5-7 positions were selected at the non-meridian and non-acupoint points(points with less nerve distribution, sparseness, and rich muscles).
Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment.
Operation: ① Shallow needling scheme: use a disposable sterile acupuncture needle, insert the needle 0.2 inch, without twisting, and keep the needle for 20 minutes. ②Non-invasive acupuncture plan: choose a special comfort needle with no needle tip at the top of the needle, paste a disposable sterile foam pad on the non-acupoint, and use a disposable sterile flat head The acupuncture needles were pierced into the foam pad, lightly touching but not piercing the skin, and not breathing; the needles were kept for 20 minutes.
Primary Outcome Measure Information:
Title
Change in cancer therapy functional assessment
Description
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.
Time Frame
Baseline, 8, 12，24 weeks later
Title
Change in acupuncture efficacy expectation assessment
Description
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.
Time Frame
Baseline, 8, 12，24 weeks later
Title
Change of functional connectivity of whole brain
Description
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.
Time Frame
Baseline, 8, 12，24 weeks later
Title
Change of metabolism of glucose in the brain
Description
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.
Time Frame
Baseline, 8, 12，24 weeks later
Title
Change of hot flash severity
Description
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.
Time Frame
Baseline, 8, 12，24 weeks later
Secondary Outcome Measure Information:
Title
Change in sleep
Description
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
Time Frame
Baseline, 8, 12，24 weeks later
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Bai, phd
Phone
0086-15129034948
Email
bailijun@xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijun Bai
Organizational Affiliation
Health Science Center of Xi'an Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Province Hospital of Traditional Chinese Medcine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Bai, PHD
Phone
0086-15129034948
Email
bailijun@xjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
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