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Идёт набор NCT06123286

Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms

Ранняя фаза I С лечением Breast Cancer Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) Joint Pain

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: Tart Cherry, Omega 3 FA (Fish Oil).
Кому может быть актуально
Состояния в реестре: Breast Cancer, Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Joint Pain. 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
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Официальное название

An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms

Обзор

Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia. There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.

Вмешательства

  • Препарат Tart Cherry
    1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
  • Препарат Omega 3 FA (Fish Oil)
    2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) \[650 mg EPA and 450 mg DHA per capsule\] daily for 12 weeks

Первичные конечные точки

  • The primary objective is to assess changes in joint function between groups. [Срок оценки: 6 Months]
Вторичные конечные точки (5)
  • To assess changes in nociplastic pain between groups. [Срок оценки: 6 Months]
  • To assess changes in nociplastic pain between groups. [Срок оценки: 6 Months]
  • To assess changes in functional performance between groups. [Срок оценки: 6 Months]
  • To assess changes in quality of life between groups. [Срок оценки: 6 Months]
  • To assess changes in cognition between groups. [Срок оценки: 6 Months]

Критерии участия

Критерии включения

  • Breast cancer diagnosis (Stage I-III) with any hormonal status.
  • Females aged ≥ 18 years.
  • Currently receiving AI therapy.
  • BMI ≥ 27.
  • Clinical diagnosis of AIMSS.
  • Omega-3 Index \<8%.
  • Average joint pain score ≥ 4 on the Brief Pain Inventory (BPI) within 7 days of enrollment.
  • Written informed consent obtained from subject and ability and willingness of subject to comply with the requirements of the study.

Критерии исключения

  • Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto).
  • Allergy to cherries or fish/fish products.
  • Lifetime history of rheumatoid arthritis and/or inflammatory joint diseases (Including but not limited to reactive arthritis, ankylosing spondylitis, and psoriatic arthritis).
  • Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and/or insulin).
  • Lifetime history of stroke or transient ischemic attacks.
  • New use or dose change of oral or topical analgesics in the previous 14 days. (Including but not limited to opioids, non-steroidal anti-inflammatories, acetaminophen, SNRI's, SSRI's, gabapentinoids, tricyclic antidepressants, and muscle relaxants).
  • Oral or intra-articular steroid use in the previous 30 days (Including but not limited to dexamethasone, prednisone, methylprednisolone, triamcinolone, hydrocortisone).
  • History of joint fracture or surgery of the symptomatic joint in the previous 6 months.

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
Поддерживающая терапия

Центры проведения

США · 2 центра
  • Cedars-Sinai Medical Center — Los Angeles
  • CS Cancer at the Hunt Cancer Center — Torrance

Идентификаторы

NCT: NCT06123286 · IIT2022-08-CHANG-TaCO3AIMSS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗