Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma

Официальное название

Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study

Обзор

Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.

Вмешательства

• Устройство Acupuncture
  Acupuncture will be administered bilaterally on points PC6, LI 4, CV6, SP6, SP10 and ST36 on the first day of each cycle (d1), prior to administration of chemotherapy; and on d8, each session lasting between 30 to 45 minutes. Patients will continue from d1 to d8 with press-tack acupuncture needles on points PC 6, LI4, SP 6 and ST 36. On d8, patients will again undergo acupuncture, and continue with self-acupressure on the same points as the press-tack needles, until the next chemotherapy cycle.

Первичные конечные точки

• Incidence of chemotherapy-induced febrile neutropenia-related hospitalization [Срок оценки: 3 weeks]
• Duration of chemotherapy-induced febrile neutropenia-related hospitalization [Срок оценки: 3 weeks]

Вторичные конечные точки (5)

• Relative Dose Intensity of Chemotherapy Regimen [Срок оценки: 3 weeks]
• G-CSF-related muscle and bone pain [Срок оценки: 3 wseks]
• Quality of life-related outcomes: Quantitative Assessment [Срок оценки: 3 weeks]
• Quality of life-related outcomes: Qualitative Assessment [Срок оценки: 3 weeks]
• Adverse effects of study intervention [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• age 18-65 years
• diagnosed with sarcoma of any stage
• scheduled for doxorubicin-based chemotherapy
• function ECOG status score of 0-1

Критерии исключения

• not fulfilling all inclusion criteria
• unwilling or unable to provide written informed consent for study participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Shaare Zedek Medical Center — Jerusalem

Публикации

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• Li S, Huang J, Guo Y, Wang J, Lu S, Wang B, Gong Y, Qin S, Zhao S, Wang S, Liu Y, Fang Y, Guo Y, Xu Z, Ulloa L. PAC1 Receptor Mediates Electroacupuncture-Induced Neuro and Immune Protection During Cisplatin Chemotherapy. Front Immunol. 2021 Sep 6;12:714244. doi: 10.3389/fimmu.2021.714244. eCollection 2021. PMID 34552585
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Идентификаторы

NCT: NCT06500715 · ACP-CIFN.2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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