FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients with Breast Cancer ReceivIng Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Drop-out rate (%)
研究概览
简要总结
The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.
详细描述
Rationale: Breast cancer is the most common type of cancer among women. The disease and treatment are associated with an increased risk of deterioration in physical fitness, muscle strength, nutritional status (sarcopenic obesity), mental well-being, health-related quality of life (HRQoL) and fatigue. To improve health outcomes, modifiable factors should be intervened as early as possible. The preoperative period during which patients receive neoadjuvant chemotherapy seems ideal to offer a multimodal lifestyle intervention, but is currently hardly used for this purpose. Nutritional status can be optimised through guidance from a dietician and self-monitoring of nutritional intake via a digital food diary. Additionally, offering a moderate-intensity endurance training (MIET) exercise programme during neoadjuvant intravenous chemotherapy infusion enables supervised exercise at a time when patients would otherwise be inactive. It may also improve tumour perfusion, thereby increasing the effectiveness of cytostatic uptake into the tumour and counteracting resistance to cytostatic drugs. The last six weeks prior to surgery can be used to further optimise cardiorespiratory fitness and muscle strength through a high-intensity interval training (HIIT) and strength training programme. Before the effect of a preoperative, multimodal lifestyle intervention in breast cancer patients receiving neoadjuvant chemotherapy can be investigated, its feasibility needs to be investigated first.
Objective: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.
Study design: A prospective, single-centre, longitudinal mixed-methods feasibility study.
Study population: Patients with breast cancer scheduled for neoadjuvant chemotherapy and surgery at the MUMC+ Comprehensive Cancer Center.
Intervention: The multimodal lifestyle intervention consists of three modalities. Patients are asked to complete 11 sessions of MIET during intravenous chemotherapy infusion, 8 sessions of HIIT and strength training in the last six weeks prior to surgery, and 4 consultations with a dietician throughout the preoperative period. The MIET training sessions consist of 45-50 minutes training programme on a cycle ergometer during the chemotherapy infusion. The physiotherapist will additionally advise patients to adhere (or build up to) the Nederlandse Norm Gezond Bewegen (NNGB) on remaining weekdays. The HIIT and strength training sessions consist of a 25 minutes training programme performed on a cycle ergometer, followed by four muscle-strengthening exercises. During the consultations with the dietician, patients' energy and protein intake are evaluated and advice is given on how to achieve the calculated energy and protein requirements. To improve patient self-management and empowerment, patients are also advised to use a free digital food diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant intravenous chemotherapy at the MUMC+
- •Aged ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Scale grade 0-1 (Table 1)
- •Enough understanding of the Dutch language
排除标准
- •Human Epidermal growth factor Receptor 2 (HER2) - positive tumour
- •Scalp cooling
- •Conditions that seriously hamper physical exercise
- •Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible.
结局指标
主要结局
Drop-out rate (%)
时间窗: Week 1-22
Number of participants who dropped out divided by the total number of participants
Recruitment rate (%)
时间窗: Week 0
Number of included patients / number of eligible patients within the study period
Characteristics of included participants
时间窗: Week 0
Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).
Attendance rate for MIET sessions (%)
时间窗: Week 10-20
Number of attended sessions / total number of planned sessions
Adherence rate, exercise relative dose intensity (ExRDI) MIET (%)
时间窗: Week 10-20
ExRDI = completed exercise dose intensity / prescribed exercise dose intensity. Completed exercise dose intensity is defined as total duration (min.) performed in targeted HR zones \* total training duration (min.) performed. Prescribed exercise dose intensity is defined as total duration (min) prescribed in targeted HR zones \* prescribed training duration. ExRDI MIET = calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.
Reasons for not having executed a training session as intended
时间窗: Week 10-20
Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.)
Attendance rate HIIT + strength sessions (%)
时间窗: Week 17-22
Number of attended sessions / total number of planned sessions
Adherence rate, ExRDI HIIT training (%)
时间窗: Week 17-22
ExRDI = completed exercise dose intensity / prescribed exercise dose intensity. Completed exercise dose intensity is defined as total duration (min) work intervals \* completed work rate (W) work interval. Prescribed exercise dose intensity is defined as prescribed total duration (min) work intervals \* prescribed work rate (W) work interval. ExRDI HIIT is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.
Adherence rate, ErXDI strength training (%)
时间窗: Week 17-22
ExRDI = completed exercise dose intensity / prescribed exercise dose intensity. Completed exercise dose intensity is defined as completed training volume (weight \* sets \* repetitions) Prescribed exercise dose intensity is defined as prescribed training volume (weight \* sets \* repetitions) ExRDI strength training is calculated per participant per training session for each exercise and for all four exercises cumulative. And cumulative for all training sessions; and cumulative for all participants.
Attendance rate for dietary consultations (%)
时间窗: Weeks 9, 15, 20 and 22
Number of attended sessions / total number of planned sessions
Percentage of days on which nutritional requirements were achieved (%)
时间窗: Weeks 15, 20 and 22
Number of days on which individual nutritional recommendations (energy and protein intake) were achieved / number of days on which 'Mijn Eetmeter' is filled out
Time point of drop-out
时间窗: Week 1-22
Time point in the study (week number after inclusion) during which patients drop-out
Reasons for drop-out
时间窗: Week 1-22
Reasons for drop-out
Serious adverse events (SAE)
时间窗: Week 10-22
Any untoward medical occurrence or effect that: * results in death; * is life threatening (at the time of the event); * requires hospitalisation or prolongation of existing inpatients' hospitalisation; * results in persistent or significant disability or incapacity; * is a congenital anomaly or birth defect; or * any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator. An elective hospital admission will not be considered as a serious adverse event.
Percentage of use of the digital food diary 'Mijn Eetmeter'(%)
时间窗: Weeks 15, 20 and 22
Number of days the food diary is filled out / total number of days agreed to complete
Reasons for not achieving the nutritional requirements as intended
时间窗: Weeks 15, 20 and 22
Reasons for not achieving the nutritional requirement as intended
Study related adverse events
时间窗: Week 10-22
Any occurrence of the following study related adverse events during or immediately after a MIET or HITT and strength training session: * Early termination of the training, because of the occurrence of one of the subjective or objective termination criteria (as described in section 5.1) * extravasation (unintentional leakage of the chemotherapy agent from the vein into the surrounding tissue * collapse * severe muscle pain lasting \>2 days * dizziness * severe nausea * excessive sweating * palpitations or chest pain during exertion
Acceptance - Barriers and enablers regarding participation in the study
时间窗: Week 22
Barriers and enablers regarding participation in the study as perceived by patients. Barriers and enablers are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+. Topic guide: * Which factors have positively influenced participation in the intervention? * Which factors have negatively influenced participation in the intervention?
Acceptance - Experiences with the multimodal lifestyle intervention
时间窗: Week 22
Experiences with the multimodal lifestyle intervention as perceived by patients. Experiences are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+. Topic guide: * What was your experience with the multimodal lifestyle intervention in general? * What was your experience with the Moderate-intensity endurance training (MIET) during intravenous chemotherapy infusion? * What was your experience with the High-intensity interval training (HIIT) and strength training * What was your experience with the nutritional counselling and use of the digital food diary 'Mijn Eetmeter'?
Acceptance - Suitability of the multimodal lifestyle intervention and study procedures
时间窗: Week 22
Suitability of the intervention and study procedures as perceived by patients Suitability is explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+. Topic guide: * Did you consider the intervention to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy? * Did you consider the study procedures to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy?
次要结局
- Fatigue(Week 0, 9, 17, 20, 22)
- Cardiorespiratory fitness(Week 0, 9, 17, 20, 22)
- Muscle strength(Week 0, 9, 17, 20, 22)
- Height (cm)(Week 9)
- Body Mass Index (BMI)(Week 9, 15, 20, 22)
- Energy and protein intake (absolute kcal and gr and gr/kg body weight per day)(Week 9, 15, 20, 22)
- Energy requirements (kcal)(Week 9)
- Nutritional status(Week 0, 9, 15, 20, 22)
- Weight (kg)(Week 9, 15, 20, 22)
- Protein requirements(Week 9)
- Circumference of upper arm and waist (cm)(Week 9, 15, 20, 22)