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NCT Number: NCT05460819

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

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.

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Key information

Conditions

Hot Flashes Acupuncture Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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 after chemotherapy (if any);
  • Eastern Cooperative Oncology Group score of 0-1 points.
  • Sign the informed consent and voluntarily participate in this clinical observation.

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;
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in cancer therapy functional assessment

    Time frame: Baseline, 8,24 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.

  2. Change in acupuncture efficacy expectation assessment

    Time frame: Baseline, 8,24 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.

  3. Change of functional connectivity of whole brain

    Time frame: Baseline, 8,24 weeks later

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

  4. Change of metabolism of glucose in the brain

    Time frame: Baseline, 8,24 weeks later

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

  5. Change of hot flash severity

    Time frame: Baseline, 8,24 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

  1. Change in sleep

    Time frame: Baseline, 8,24 weeks later

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lijun Bai, phd

CONTACT

[email protected]

0086-15129034948

Sponsors and collaborators

Lead sponsor

Nanjing University of Traditional Chinese Medicine

Other

Collaborators

  • Xi'an Jiaotong University

Registry information

Official study title

A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2022
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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