Exercise regiMens Before and duRing Advanced Cancer thErapy: A Pilot Study to Investigate Improvements in Physical Fitness With Exercise Training Programme Before and During Chemotherapy in Advanced Lung Cancer Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants completing exercise sessions as a function of the whole programme.
研究概览
简要总结
Trial Phase: Pilot
Indication: Stage IIIB/IV NSCLC
Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy.
Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness.
- To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline.
4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation.
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To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy.
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To document the effects of chemotherapy on cellular energetics and mitochondrial function.
Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training.
Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm.
Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).
详细描述
EMBRACE is a multi-centre pilot study for 100 patients with EGFR negative NSCLC undergoing first line platinum based chemotherapy. It is a prospective randomised (1:1) 2-arm controlled study. A nested mechanism study will be performed in a sub group of patients willing to have muscle biopsies.
Patients will be randomised to the exercise intervention or the control arm. All patients will undergo standard chemotherapy with gemcitabine and carboplatin (or equivalent) for 12 weeks. Patients randomised to the intervention arm will undergo concurrent exercise training during their 12 weeks of chemotherapy treatment. Patients randomised to the control arm will undergo chemotherapy only. During the 12 weeks of the study, assessments will be performed on all patients (including CPET tests and HRQL questionnaires). The exercise training sessions and study assessments will not affect timing of delivery of chemotherapy. Patients who decline randomisation will be offered entry into an observational study.
The follow-up phase will commence when patients have completed 12 weeks of chemotherapy, or sooner for patients who stop chemotherapy early due to progressive disease or toxicity. During the follow-up phase data will be for survival and to follow any AEs related to study procedures. AEs not related to study procedures will not require follow up. Ongoing chemotherapy after week 12 will be as per investigator and patient choice, and may include further induction cycles, maintenance chemotherapy, or observation.
In a subgroup of willing patients muscle biopsies will be performed at baseline, during chemotherapy, and after completion of chemotherapy.
TRIAL OUTCOME MEASURES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Cardiopulmonary exercise testing assessor, outcome/toxicity assessor
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
- •Male or female patients, aged over 18 years old
- •Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- •Stage IIIb/IV disease
- •Patients being treated with first line gemcitabine and platinum based chemotherapy (other equivalent regimens may be considered on discussion with Judith Cave)
- •Performance status 0-2 (PS 2 have to be deemed fit enough to complete all cycles of chemotherapy).
排除标准
- •Unable to consent
- •Under 18 years
- •Unable to perform CPET
- •Significant cardiac ischaemia of > 1.5mm symptomatic and > 2mm asymptomatic observed on the baseline ECG
- •Weight of >145kg (weight limit for cycle ergometer)
- •Any other contraindication to CPET based on ACCP/ATS Guidelines and summarised in the table below.
研究组 & 干预措施
Exercise Intervention
Patients in the intervention arm will participate in a supervised in-hospital, exercise training program on a cycle ergometer before and during chemotherapy. At week 5-6 there will be a transition period of in-hospital to home-based exercise training (at this point we will perform the exercises that they will perform at home in the in-hospital environment to ensure that the patient understands the home-based exercise training programme) and then week 7-12 will be home-based exercise training only with telephone support.
干预措施: Exercise (Behavioral)
Negative Control
Patients in the control arm will not undergo an exercise training program.
Observational
Patients who do not enrol in RCT will be enrolled in the observational arm
结局指标
主要结局
Number of participants completing exercise sessions as a function of the whole programme.
时间窗: 12 weeks
Adherence to the exercise training program
Adverse events
时间窗: 12 weeks
Common Terminology on Complications (CTC AE v4)
次要结局
- Grip strength(12 weeks)
- Physical activity(12 weeks)
- Survival(1 year)
- Response to chemotherapy(12 weeks)
- Timed up and go test (TUG)(12 weeks)
- Montreal score - Prognostic survival score(12 weeks)
- Fitness levels as measured by Cardiopulmonary exercise testing (CPET)(12 weeks)
- Health related quality of life questionnaire(12 weeks)