Acupuncture to Prevent Nausea and Vomiting After Stem Cell Transplant

Официальное название

Clinical Study and Mechanism Exploration of Acupuncture at Neiguan (PC6) for Preventing Nausea and Vomiting in Patients Undergoing Hematopoietic Stem Cell Transplantation

Обзор

This study is testing whether acupuncture at a point on the wrist called "Neiguan" can help reduce nausea and vomiting in patients undergoing stem cell transplantation. Participants will receive either real acupuncture or standard care. We hope to find a safe way to improve comfort during cancer treatment.

Вмешательства

• Процедура Acupuncture
  Add-on manual acupuncture at bilateral Neiguan (PC6) to standard quadruple anti-emetic prophylaxis. Disposable sterile acupuncture needles inserted perpendicularly 0.5-1 cun (approximately 10-25 mm) into Neiguan with even reinforcing-reducing manipulation; needles retained for 30 minutes. Administered once daily throughout the conditioning (preparative) regimen. This distinguishes the intervention from: (1) the active comparator arm in this study, which receives identical pharmacological prophy
• Препарат Conventional care
  Standard quadruple pharmacological anti-emetic prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, dexamethasone, and olanzapine, administered per institutional HSCT supportive care protocol. No acupuncture or sham procedure is provided. This distinguishes the arm from the experimental arm, which receives the identical pharmacological regimen plus add-on manual acupuncture at Neiguan (PC6).

Первичные конечные точки

• Incidence and severity of nausea and vomiting during the conditioning regimen for hematopoietic stem cell transplantation [Срок оценки: Throughout the conditioning period (approximately 3-7 days)]

Вторичные конечные точки (1)

• Nutritional status assessed by serum albumin and prealbumin levels [Срок оценки: Baseline (pre-conditioning), Day 7, Day14, and Day 28 of conditioning, and Day 30 post-transplant]

Критерии участия

Критерии включения

Age 18-65 years, either sex. Patients scheduled to receive a conditioning (preparative) regimen for hematopoietic stem cell transplantation (HSCT).

Life expectancy ≥ 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment.

Voluntary participation with signed informed consent.

Критерии исключения

Received chemotherapy with highly emetogenic agents within 14 days prior to enrollment.

Received radiotherapy within 7 days prior to enrollment, or planned radiotherapy during the study period.

Known hypersensitivity to any study drug or its excipients. Complicated with gastrointestinal obstruction, brain metastasis with symptoms of increased intracranial pressure, or any other condition that may cause and/or exacerbate nausea and vomiting.

Active infection. Unable to take oral medications. Use of any anti-emetic medication (including corticosteroids) within 48 hours or 5 half-lives of the drug (whichever is longer) prior to enrollment.

Any episode of nausea, vomiting, or retching within 24 hours prior to the first administration.

Severe psychiatric illness or cognitive impairment that precludes understanding, reading, and completing patient diaries.

Any other condition that the investigator deems would make the patient unsuitable for participation in this study.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• The General Hospital of Western Theater Command — Чэнду

Идентификаторы

NCT: NCT07747194 · PC6-HSCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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