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临床试验/NCT05786014
NCT05786014已完成不适用

A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies

University of Virginia2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Subject Retention Percentage

研究概览

简要总结

The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, inflammatory responses, and quality of life.

详细描述

Breast cancer is the most common malignancy affecting women in the US and survivors experience long-term health effects of chemotherapy. Exercise training is an efficacious treatment for preserving functional capacity and has shown promise in mitigating cardiac toxicity of breast cancer chemotherapy. However, supervised exercise is not a practical solution for all breast cancer survivors, as medically monitored exercise facilities are poorly dispersed in the US and poorly utilized by cancer patients. To improve reach of these programs, remotely monitoring exercise sessions may be necessary. However, effects of remotely-monitored exercise conditioning before and during adjuvant/neoadjuvant chemotherapy on cardiotoxic outcomes are unknown. Our study aims to address this gap by testing the feasibility of two types of remotely-monitored exercise interventions, an exercise bicycle intervention compared to a brisk walking intervention, in 20 UVA Breast Cancer Clinic patients undergoing cardiotoxic chemotherapies. Remotely-monitored exercise training will start one week prior to chemotherapy (preconditioning) and continue throughout adjuvant or neoadjuvant chemotherapy (which is typically 4 months in duration). Our multidisciplinary research team proposes four aims: 1) Determine the extent to which eligible patients can be successfully recruited, randomized, and retained; 2) Assess VO2peak, echocardiography derived left ventricular ejection fraction and left ventricular global longitudinal strain among these patients at baseline and at ~4 months; 3) Examine treatment engagement and intervention acceptability; and 4) Explore the relationship between engagement in the exercise training and psychosocial function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Subjects and investigators will not be blinded to treatment allocation. Outcome assessors will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years or over
  • diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC (Docetaxel/Cyclophosphamide), AC (Doxorubicin/Cyclophosphamide followed by Paclitaxel), TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab), TCH (Docetaxel/Carboplatin/Trastuzumab) with or without Pembrolizumab)
  • Physician clearance for exercise training
  • Speak/understand English

排除标准

  • previous treatment with cardiotoxic chemotherapy
  • medical/orthopedic comorbidities that preclude stationary cycling
  • significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
  • unstable angina or myocardial infarction within 4-weeks prior to treatment
  • complex ventricular arrhythmias or New York Heart Association class IV symptoms
  • symptomatic severe aortic stenosis
  • acute pulmonary embolus
  • acute myocarditis
  • History of untreated high-risk proliferative retinopathy
  • History of retinal hemorrhage
  • uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg)
  • severe baseline electrolyte abnormalities
  • medication non-compliance
  • uncontrolled metabolic disease (diabetes with fasting blood sugar >300 mg/dl, thyrotoxicosis, myxedema)
  • symptomatic peripheral vascular disease
  • Pregnant women

结局指标

主要结局

Subject Retention Percentage

时间窗: 22 Weeks

This is a feasibility study designed to determine the extent to which eligible patients can be successfully recruited, randomized, and retained. Endpoint data will be used to justify and provide point estimates for a fully powered study. Retention will be measured as a percentage of those enrolled who complete the study interventions.

次要结局

  • Diastolic Function(22 Weeks)
  • Ejection Fraction(22 Weeks)
  • Brachial Artery Endothelium-Dependent Flow-Mediated Dilation(22 Weeks)
  • VO2peak(22 Weeks)
  • Global Longitudinal Strain(22 Weeks)
  • Carotid-Femoral Pulse Wave Velocity(22 Weeks)
  • Inflammation/Immune cell concentrations in peripheral circulation.(22 Weeks)
  • Blood pressure(22 Weeks)
  • Lipid panels(22 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siddartha Angadi

Assistant Professor of Education

University of Virginia

研究点 (2)

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