Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
The aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage IIb-IV melanoma undergoing immunotherapy or targeted therapy. Additionally, we will investigate whether a supervised exercise program improves patients' quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. We will also examine other health outcomes and various blood parameters, such as interleukins and metabolites, to understand how regular activity can affect metabolism and immune function.
After the initial assessment at the clinic, patients will be randomly assigned to two groups. Those in the intervention group will participate in a 12-week exercise program, which includes a 60-minute personalized and supervised online training session twice a week. In weeks 3, 6, and 9, one training session will be held at the clinic. Furthermore, patients in the intervention group are encouraged to complete a self-administered 20-minute exercise session once a week. The control group will not receive a supervised exercise program. Following the 12-week intervention period, another assessment will be conducted at the clinic. All patients will then enter a 6-week follow-up phase, during which neither group will receive supervised exercise training. After this follow-up phase, a final assessment of all outcomes will take place at the clinic.
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
- 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 ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy
- •patients with ECOG level 0-2
- •patients already on the same treatment protocol for at least 3 months and no more than 9 months
- •sufficient knowledge of German
- •completed and signed written consent form and completed medical history form
- •medical clearance for the exercise program and performance diagnostics
- •ability to participate in the exercise program
- •willingness to visit the study hospital for training sessions and examinations
排除标准
- •confirmation of contraindications for physical exercise by the attending physician (e.g. fracture risk in the case of bone metastases)
- •untreated, symptomatic, known brain metastases
- •severe neurological or cardiac impairment according to ACSM criteria
- •confirmation of respiratory insufficiency by the attending physician
- •life expectancy less than 3 months
- •physical or mental conditions that would not allow implementation of the exercise program or study protocol
- •excessive physical activity (i.e. >150 minutes/week of moderate to intense physical activity and systematic intense strength/endurance training at least twice a week for one hour)
研究组 & 干预措施
Control Group
Control group will receive usual care without an exercise program. After the final endpoint assessment, patients randomized into the control group will be offered the opportunity to participate in an exercise program conducted by the Sports and Exercise Therapy Group at WTZ Essen.
Exercise Intervention
The supervised progressive endurance and resistance exercise program will be conducted twice per week online in small groups and will be guided by a sports scientist over a period of 12 weeks. All sessions will start with a warm-up, transitioning to endurance training, followed by strength exercises and finishing with a cool-down, and will take approximately 60 minutes. The moderate-to-high-intensity endurance training will be performed at the beginning of each training session for 15 minutes in the range of the ventilatory threshold 1 (VT1), which was obtained during the baseline cardiorespiratory exercise test. The moderate-to-high-intensity progressive resistance training and bodyweight regime will include 6 exercises that target major upper and lower body muscle groups as well as trunk exercises. Resistance exercise includes free weight, resistance bands, and bodyweight workouts.
干预措施: Supervised 12-week Resistance and Endurance Exercise Program (Behavioral)
结局指标
主要结局
Fatigue
时间窗: From baseline assessment to the end of treatment at 12 weeks
Fatigue will be assessed with the validated 40-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F, version 4). It includes four multi-item functional scales (physical, social, emotional and functional well-being) and a multi-item symptom scale (fatigue).
次要结局
- Weight(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Height(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- BMI(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Blood pressure at rest(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Resting heart rate(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Fatigue(From the end of treatment to follow-up assessment at 18 weeks)
- Quality of life of melanoma patients(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Physical Activity Behaviour(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Strength of large muscle groups(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Cardiopulmonary fitness(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Cognitive Performance(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Body composition(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Side effects/ symptoms(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Response to therapy(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Blood parameters(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Adherence(During the intervention phase)
- Fatigue(From the end of treatment to follow-up assessment at 18 weeks)
- Quality of life of melanoma patients(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Physical Activity Behaviour(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Strength of large muscle groups(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Cardiopulmonary fitness(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Cognitive Performance(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Body composition(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Weight(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Height(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- BMI(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Blood pressure at rest(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Resting heart rate(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Side effects/ symptoms(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Response to therapy(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Blood parameters(From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks)
- Adherence(During the intervention phase)
- Assessment of Safety(During the intervention phase)
研究者
Miriam Götte
PD Dr.
Universität Duisburg-Essen