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Идёт набор NCT06915116

Acupuncture for People Experiencing Period Loss Due to Chemotherapy

Фаза II С лечением Cancer Period Problem

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, No Acupuncture.
Кому может быть актуально
Состояния в реестре: Cancer, Period Problem. Базовые параметры: 15 лет — 40 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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Официальное название

Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)

Обзор

The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.

Вмешательства

  • Процедура Acupuncture
    Acupuncture will be delivered by licensed experienced acupuncturists at MSK. The intervention includes 12 treatments of acupuncture over 12 weeks (i.e. one treatment a week) with a +/- 14-day window. This window applies to the 12-week treatment period rather than to individual visits. The minimum required time between each treatment is 48 hours. When patients experience menses recovery during the treatment period, they have the option to discontinue treatment or continue receiving up to 12 acupu
  • Другое No Acupuncture
    Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period

Первичные конечные точки

  • Enrollment rate [Срок оценки: 1 year]
  • Acupuncture treatment adherence rate. [Срок оценки: up to 16 weeks]
Вторичные конечные точки (1)
  • Menses recovery [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • English speaking woman between the ages of 15 and 40
  • History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team
  • Premenopausal status with regular menstruation at the time of diagnosis by patient report
  • Completed cytotoxic chemotherapy within the past year
  • Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older
  • Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
  • Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old
  • Patient reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
  • Have been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy
  • Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC

Критерии исключения

  • Had been pregnant or lactating within 3 months prior to enrollment
  • History of hysterectomy or bilateral oophorectomy
  • Ongoing or planned radiation or surgery within 4 months from randomization
  • Use of acupuncture for menses recovery within 3 months of enrollment
  • Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period

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
Открытое
Основная цель
Лечение

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre

Идентификаторы

NCT: NCT06915116 · 25-020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗