NCT07216495招募中不适用
Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
To learn if participating in a supervised exercise program can help participants with early-stage TNBC who are receiving ICI therapy before undergoing breast surgery.
详细描述
Primary Objective To evaluate the feasibility of a supervised cardiorespiratory exercise program in patients with clinical stage 2-3 Triple Negative Breast Cancer (TNBC) undergoing neoadjuvant chemotherapy with immune checkpoint inhibitor therapy.
Secondary Objectives To explore the relationship between cardiorespiratory exercise and circulating immune (CD8+ T) cells in the peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male participants 18 years or older and willing to provide Informed Consent
- •clinical stage 2 or 3 TNBC (estrogen receptor and progesterone receptor ≤ 10% by immunohistochemistry (IHC) and human epidermal growth factor-2 (HER2) negative (IHC 0, IHC1+, or IHC 2+ with negative fluorescence in situ hybridization))
- •Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device
- •Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1
- •Planned receipt of neoadjuvant chemoICI therapy (carboplatin/taxane in combination with pembrolizumab; taxane options are weekly paclitaxel or every 3 week docetaxel)
- •clearance to participate in the study by the patient's medical oncologist
- •normal bone marrow function
- •able to read/complete study forms/assessments and understand instructions in English
排除标准
- •a) Any physical condition which hinders the ability to safely participate in exercise including: uncontrolled or symptomatic cardiac/respiratory disease (e.g. uncontrolled angina, unusual shortness of breath, congestive heart failure, symptomatic peripheral vascular disease), stroke/myocardial infarction in the past year, fragility fracture, recent or planned orthopedic surgery, or any comorbid condition precluding exercise per the treating physician b) receipt of medications known to influence immune function including corticosteroids (>10 mg prednisone equivalent), other immune-suppressive medication, or beta blockers47 c) Any infection or vaccination within the last 4 weeks d) e) Known HIV-positive participants on combination antiretroviral therapy f) concurrent participation in a therapeutic clinical trial or other exercise program g) pregnant h) medically advised to not exercise i) Unable to walk on a motor-driven treadmill for ~30 minutes at study enrollment j) Adults unable to consent k) No external catheters/drains (e.g., nephrostomy tube, foley catheter). A colostomy or Ileostomy is acceptable.
- •l) Prior or concurrent non-breast malignancy. Those with prior cancers treated with curative intent are eligible. Participants with known (or history) of hepatitis B positive, or hepatitis C positive infection
研究组 & 干预措施
Acute cardiorespiratory exercise program
Experimental
consisting of 4 in-clinic exercise sessions
干预措施: Exercise (Other)
结局指标
主要结局
Adherence
时间窗: Approximately 8 weeks
Feasibility will be measured by adherence to both exercise frequency and time (duration/intensity) at the supervised sessions.
次要结局
- Circulating immune (CD8+ T) cells in the peripheral blood(Approximately 8 weeks)
研究者
研究点 (1)
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