Набор скоро начнётся NCT07695948

Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors

Фаза III С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Acupuncture, Sham acupuncture.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to examine the effect, mediators and predictors of treatment response of acupuncture in treating the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) among breast cancer survivors.

Подробное описание

Aim 1: compared to sham acupuncture and UC, determine the effect of acupuncture on a) the psychoneurological cluster (primary outcome) and b) pain, fatigue, and sleep disturbance as individual symptoms (secondary outcomes).

Aim 2: examine the role of methylsulfonylmethane as mediator in the mechanisms of acupuncture on the psychoneurological cluster and each individual symptom from week 0 to week 6 (primary endpoint) and to week 12 (secondary endpoint).

Aim 3: identify multilevel predictors of treatment response in the acupuncture group, including a) biological (metabolomic signature, age); 2) clinical (previous treatment) and 3) psychosocial (treatment expectancy) characteristics.

Вмешательства

Поведенческое Acupuncture
All participants will receive a semi-standardized acupuncture protocol with needle penetrating to the skin. Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.
Поведенческое Sham acupuncture
Participants will receive no-touch control needle on non- acupuncture points, with the tip that does not contact the skin. Participants will receive 2 sham acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each sham acupuncture treatment will take 30 minutes.

Первичные конечные точки

The psychoneurological symptom cluster [Срок оценки: week 0, week 6, week 12, week 24]

Вторичные конечные точки (5)

PROMIS Pain Interference [Срок оценки: week 0, week 6, week 12, week 24]
PROMIS fatigue [Срок оценки: week 0, week 6, week 12, week 24]
PROMIS sleep disturbance [Срок оценки: Scores range from 4-20; higher scores indicate that severe fatigue]
Serum methylsulfonylmethane concentration [Срок оценки: week 0, week 6, week 12]
GSH/GSSG [Срок оценки: week 0, week 6, week 12]

Критерии участия

Критерии включения

≥ 18 years of age
With histologically confirmed Stage 0-III ER/PR-positive HER2-negative breast cancer
Currently receiving adjuvant endocrine therapy
Completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior to recruitment
Acupuncture-naïve
Have self- reported pain, fatigue, and sleep disturbance in the last month with an average severity rating ≥ 3 (0-10 numeric rating scale) for at least 2 of the 3 symptoms.