A Phase I, Pilot Study, Single-group Investigating the Feasibility of Exercise During Oxaliplatin Infusions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluating the feasibility (adherence) of the intervention by patients
研究概览
简要总结
This single group study was conducted to test the feasibility and acceptability of implementing an exercise intervention during oxaliplatin infusion across three months of oxalipatin-based chemotherapy in patients with gastrointestinal malignancies.10 patients were enrolled onto this study and validated questionnaires were used to evaluate the feasibility and acceptability of the intervention and collect patient-reported outcomes over the course of study enrollment.
详细描述
The proposed study is a single arm study to evaluate the feasibility and acceptability of having patients exercise while receiving oxaliplatin infusions in the infusion center. The study will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancersor for cancer of unknown primary.
Patients will be provided with a wrist heart rate monitors to be used during the infusions. They will wear the heart monitors during the entirety of the oxaliplatin chemotherapy infusion. Patients will be asked to engage in aerobic exercise using a pedal machine to move their arms and legs while in a seated position. Patients will be asked to exercise for a total of 30 minutes, which will be divided into three, ten minute bouts of exercise, spaced out in 30 minute blocks of time.
The comprehensive surveys including EORTC-QLC-CIPN20 and PROMIS-29 QOL will be completed at baseline, ~6-8 weeks into treatment, and at ~12-14 weeks after treatment initiation. The feasibility and acceptability instruments will be administered ~6-8 weeks into treatment.
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
- •Receiving care at Dartmouth-Hitchcock Medical Center in Lebanon, NH
- •Age >18 years
- •Eastern Cooperative Oncology Group Status 0 to 2;
- •Diagnosed gastrointestinal cancer of any stage
- •Scheduled to receive at least 4 cycles of oxaliplatin
- •Complete the International Physical Activity Questionnaire score equal to or greater than 99 MET minutes/week (equivalent to ~30 minutes of walking)
- •Have mediport access prior to enrollment in the study
排除标准
- •Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and/or based on consultation with the medical oncologist;
- •Scheduled major surgery during the study time period;
- •Pre-existing peripheral neuropathy prior to chemotherapy;
- •Patient with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator;
- •Prior history of treatment with oxaliplatin, docetaxel, or paclitaxel
- •Pregnant women;
- •Inability to read or speak English/unable to consent;
- •Prognosis of less than six months
研究组 & 干预措施
Exercise and Oxaliplatin-induced peripheral neuropathy
A single arm to evaluate the feasibility and acceptability of having patients exercise during oxaliplatin infusions in the infusion center. Arm will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancer or for cancer of unknown primary.
干预措施: Aerobic Exercise (Other)
结局指标
主要结局
Evaluating the feasibility (adherence) of the intervention by patients
时间窗: 14 weeks
* 70% of patients completing \>60% of the exercise sessions during all infusion session * 60% of patients identifying "agree" or "strongly agree" on the Feasibility of Intervention Measure (FIM), a validated instrument
Evaluating the acceptability of the intervention by patients
时间窗: 14 weeks
≥60% of patients identifying "agree" or "strongly agree" on the Acceptability of Intervention Measure (AIM), a validated instrument
次要结局
- Describe changes in quality of life via questionnaires(14 weeks)
- Observe trends of exercise via questionnaires at various time points(14 weeks)
研究者
Natasha Dhawan
Principal Investigator
Dartmouth-Hitchcock Medical Center