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Идёт набор NCT04997096

Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy

Без фазы С лечением Ovarian Cancer Ovarian Carcinoma Ovarian Cancer Stage IV Ovarian Cancer Stage III

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: Exercise, Attention Control.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III. 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 research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).

Подробное описание

This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.

The names of the study interventions involved in this study are/is:

* Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom * Attention control for 16 weeks, home-based stretching

The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.

It is expected that about 30 people will take part in this research study.

Вмешательства

  • Другое Exercise
    16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
  • Другое Attention Control
    Home-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer.

Первичные конечные точки

  • Proportion of patients completing the exercise intervention sessions. [Срок оценки: 16 Weeks]
  • Enrollment Rate [Срок оценки: 16 Weeks]
Вторичные конечные точки (4)
  • Short Physical Performance Battery (SPPB)-Lower Extremity Function [Срок оценки: 16 Weeks]
  • Change in 6-minute walk distance [Срок оценки: 16 weeks]
  • PROMIS- Physical function [Срок оценки: 16 Weeks]
  • Number of Participants with Treatment Related Adverse Events [Срок оценки: 16 Weeks]

Критерии участия

Критерии включения

  • Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
  • Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
  • ≥18 years, children under the age of 18 will be excluded due to rarity of disease
  • Physician's clearance to participate in moderate-vigorous intensity exercise
  • Able to read, write, and understand English
  • Ability to understand and the willingness to sign an informed consent document
  • Willing to undergo two venous blood draws for the study

Критерии исключения

  • Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
  • Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
  • Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)

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 · 1 центр
  • Dana Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT04997096 · 21-299

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗