Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy

Обзор

This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.

Подробное описание

This study is a parallel-group, blinded (participant, evaluator, and statisticians), randomized controlled trial to investigate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy. Patients in each group will receive electroacupuncture or sham electroacupuncture during the first week of the chemotherapy cycle. They will receive self-acupressure or sham acupressure during the second and third weeks of the chemotherapy cycle. Participants will be asked to complete the EQ-5D-5L and FACT-B scales. Primary and secondary outcomes will be assessed.

Вмешательства

• Комбинированный продукт electroacupuncture+ self-acupressure
  Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi"; is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2/10Hz for 30 minutes. self-acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint
• Комбинированный продукт sham electroacupuncture + sham self-acupressure
  Sham electroacupuncture: The sham electroacupuncture shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi"; sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure poin

Первичные конечные точки

• Differences in quality of life during the overall stage [Срок оценки: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle]

Вторичные конечные точки (3)

• Differences in quality of life during the overall stage [Срок оценки: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle]
• Changes in scores on the five dimensions of the EQ-5D-5L [Срок оценки: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle]
• Changes in the dimensions of the FACT-B scale [Срок оценки: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle]

Критерии участия

Критерии включения

• Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Patients who have not received prior chemotherapy and are scheduled to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy or combination targeted therapy;
• Normal organ function with platelets ≥ 100\*10\^9/ L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 mg/dl (133 mmol/L), or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase ≤ 2.5 times ULN, and aspartate aminotransferase ≤ 2.5 times ULN;
• Premenopausal women need appropriate contraception;
• Ability to understand the study well and complete the study questionnaire.

Критерии исключения

• Patients with needle phobia or allergy to stainless steel needles; and
• Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
• History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
• Comorbid bleeding disorders or thyroid dysfunction;
• Implantation of a pacemaker; pregnancy or breastfeeding;
• A plan for adjuvant radiotherapy in the upcoming chemotherapy cycle;
• Current active infection;
• Acupuncture treatment within the last four weeks;
• Patients who are allergic to the drugs used;
• Use of other Traditional Chinese Medicine (TCM) techniques such as Chinese herbs in the next chemotherapy cycle.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qinghai University Affiliated Hospital — Xining

Идентификаторы

NCT: NCT06601621 · AHQU-2024002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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