Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
研究概览
简要总结
The purpose of this randomized study is to evaluate whether a six-month program of structured resistance exercise combined with individualized nutritional support can preserve or improve skeletal muscle mass and muscle quality in adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors.
Participants will be randomly assigned either to the exercise and nutritional intervention in addition to standard oncology care or to standard oncology care alone. The study aims to obtain complete measurements from at least 40 participants.
Assessments will be performed at baseline, after 3 months, and after 6 months. They will include magnetic resonance imaging of the thigh, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, indirect calorimetry, clinical data, and patient-reported outcomes. The study will compare changes in skeletal muscle mass and volume, fatty infiltration of skeletal muscle, sarcopenia, body composition, resting energy expenditure, quality of life, fatigue, treatment tolerance, treatment delays, and early treatment discontinuation between the two groups.
Treatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.
详细描述
MEL-FIT-IO is an umbrella randomized interventional study evaluating a six-month structured resistance exercise and individualized nutritional intervention in patients with malignant melanoma receiving immune checkpoint inhibitors.
Two prespecified doctoral substudies are embedded within the parent study and use the same participants, study groups, randomization, and assessment schedule. No separate randomization is performed for the substudies.
The ultrasound substudy, protocol ORI2026-5 (US-MUMELICI), evaluates the validity and longitudinal responsiveness of skeletal muscle ultrasound. Rectus femoris shear-wave velocity, muscle stiffness, echogenicity, and thigh muscle thickness are compared with magnetic resonance imaging, dual-energy X-ray absorptiometry, and bioelectrical impedance analysis at baseline, 3 months, and 6 months.
The myokine and metabolic substudy, protocol ORI2026-35 (MY-MEL-FIT-IO), evaluates changes in circulating myokines, systemic inflammatory and immune-cell markers, metabolic parameters, body composition, treatment tolerance, and patient-reported outcomes. Biomarker analyses are performed in the prespecified subgroup of participants with metastatic melanoma.
Treatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.
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
- •Age 18 years or older.
- •Confirmed diagnosis of malignant melanoma, stage II, III, or IV.
- •Planned first-line or adjuvant treatment with immune checkpoint inhibitors.
- •Life expectancy greater than 6 months.
- •Sufficient knowledge of the Slovenian language.
- •Ability to provide written informed consent and comply with the study protocol.
排除标准
- •Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors.
- •Symptomatic brain metastases.
- •Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants.
- •Neurological diseases affecting the skeletal muscular system, such as muscular dystrophy.
- •Any condition that, in the investigator's judgment, prevents participation or the safe performance of study assessments.
- •Participation in another study that includes structured physical exercise as part of its protocol.
研究组 & 干预措施
Exercise and Nutritional Intervention
Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, together with a six-month structured resistance exercise program performed three times per week under the supervision of trained exercise professionals and individualized nutritional support.
干预措施: Structured Resistance Exercise (Behavioral)
Exercise and Nutritional Intervention
Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, together with a six-month structured resistance exercise program performed three times per week under the supervision of trained exercise professionals and individualized nutritional support.
干预措施: Individualized Nutritional Support (Behavioral)
Standard Oncology Care
Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention.
结局指标
主要结局
Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
时间窗: Baseline and 6 months
Thigh skeletal muscle volume will be quantified using magnetic resonance imaging. The change from baseline to 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Change From Baseline in Skeletal Muscle Fat Infiltration Assessed by Magnetic Resonance Imaging
时间窗: Baseline and 6 months
Skeletal muscle fat infiltration in the thigh will be quantified using magnetic resonance imaging. The change from baseline to 6 months will be compared between the two study groups.
Number of Participants With Sarcopenia at 6 Months
时间窗: Baseline and 6 months
Sarcopenia will be assessed based on study measurements of skeletal muscle mass and muscle function. The number and proportion of participants with sarcopenia at 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group, taking baseline sarcopenia status into account.
次要结局
- Mean Change From Baseline in Resting Energy Expenditure Assessed by Indirect Calorimetry(Baseline and 6 months)
- Change From Baseline in Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry(Baseline, 3 months, and 6 months)
- Mean Change From Baseline in Total Body Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry(Baseline, 3 months, and 6 months)
- Number of Participants With at Least One Immunotherapy Treatment Delay(From baseline through 6 months)
- Number of Participants With Premature Discontinuation of Immune Checkpoint Inhibitor Treatment(From baseline through 6 months)
- Number of Participants With Grade 3 or Higher Immune Checkpoint Inhibitor-Related Toxicity(From baseline through 6 months)
- Mean Change From Baseline in Phase Angle Assessed by Bioelectrical Impedance Analysis(Baseline, 3 months, and 6 months)