Acupuncture for Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

NCT05460819 | Not Yet Recruiting

• 1 other identifier: 2022JC-55
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 functional magnetic resonance imaging technology.

Conditions

Hot Flashes; Breast Cancer; Acupuncture

Keywords

breast cancer; Acupuncture; hot flashes; Functional MRI

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 8,24 weeks later

• 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.

  Baseline, 8,24 weeks later

• Change of functional connectivity of whole brain

  Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.

  Baseline, 8,24 weeks later

• Change of metabolism of glucose in the brain

  Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.

  Baseline, 8,24 weeks later

• 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.

  Baseline, 8,24 weeks later

Secondary Outcomes (1)

• Change in sleep

  Baseline, 8,24 weeks later

Study Arms (3)

Treatment group A

EXPERIMENTAL

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.

Other: Acupuncture treatment

Treatment group B

SHAM COMPARATOR

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).

Other: Sham Acupuncture treatment

control

NO INTERVENTION

The control group was given conventional adjuvant endocrine therapy, premenopausal patients received tamoxifen therapy, and postmenopausal patients received aromatase inhibitor or tamoxifen therapy.

Interventions

Acupuncture treatment OTHER

Acupoint selection: Hegu-Yinxi acupoint group (clearing heat and relieving sweat), Sanyinjiao-Fuliu acupoint group (nourishing yin and tonifying kidney), Tianshu-uteri acupoint group (special effect points) (12 acupoints on both sides). 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.

Treatment group A

Sham Acupuncture treatment OTHER

Selecting acupoints: Select the side opening positions of the 6 acupuncture points in the real acupuncture group, and select non-meridian and non-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.

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 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;
• Vasomotor syndrome for at least 6 weeks;
• Premenopausal or postmenopausal patients;
• Patients after surgery and after chemotherapy (if any);
• Eastern Cooperative Oncology Group score of 0-1 points.
• Sign the informed consent and voluntarily participate in this clinical observation.

You may not qualify if:

• 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;
• Unstable heart disease or myocardial infarction within 6 months prior to study start;
• 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;
• Seizures of unknown likelihood or history of seizures;
• Have used acupuncture for hot flashes within 6 months prior to the start of the study;
• Pregnant or breastfeeding patients;
• Apparent uncontrolled infection;
• Mental illness or family history; neurological disorder or family history.

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead
• Xi'an Jiaotong University: collaborator

Study Sites (1)

Jiangsu Province Hospital of Traditional Chinese Medcine

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lijun Bai, phd

  Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Lijun Bai, phd

CONTACT

0086-15129034948; bailijun@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)