Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Study feasability, measured by adequacy and efficiency of recruitment strategies
研究概览
简要总结
The treatment of melanoma has improved significantly in recent years. A modern form of cancer treatment known as immunotherapy with checkpoint inhibitors plays a key role in this. These drugs help the immune system better recognize and fight cancer cells. Nevertheless, it remains a challenge to maximize treatment effectiveness while minimizing side effects.
One possible approach to influencing treatment efficacy and tolerability is diet. A high-fiber diet, as recommended by the German Nutrition Society, increases the effectiveness of immunotherapy, in part through its influence on gut bacteria (the gut microbiota). Initial studies also show that short-term fasting (i.e., eating nothing or very little for a limited period) reduces the side effects of immunotherapy in mouse models and improves the tolerability of chemotherapy in humans.
This study investigates the feasability of a study on short-term fasting, in addition to a high-fiber diet in patiens with melanoma undergoing immunotherapy.
40 participants will follow a high-fiber diet based on the recommendations of the German Nutrition Society. Additionally, half of the participants will undergo periodic cycles of short-term fasting of 72h with each immunotherapy. Another 20 participants will not undergo any intervention and serve as a control group.
The goal is to determine whether this study concept is feasible. Exploratory outcomes include, quality of life, fatigue, tolerability of the therapy, impact on disease progression, immune system (flow cytometry) and gut bacteria (microbiome).
The results are intended to help understand whether targeted dietary measures can support the effectiveness of modern cancer treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Histologically or cytologically confirmed stage IIB-IIIC melanoma
- •Indication for immune checkpoint inhibition as monotherapy as determined by the tumor board
- •No prior systemic melanoma therapy
- •ECOG 0 or 1
- •≥ 18 years of age
排除标准
- •Pregnancy or breastfeeding
- •Underweight (BMI ≤19.5)
- •Pre-existing eating disorder
- •Severe internal medical conditions (e.g., renal insufficiency with creatinine > 2 mg/dL) or secondary malignancy
- •Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months
- •Use of antibiotics within 4 weeks prior to the start of the study intervention
研究组 & 干预措施
High-Fiber Diet
干预措施: High-Fiber Diet (Behavioral)
Observational
High-Fiber Diet and Short-Term Fasting
干预措施: High-Fiber Diet and Short-Term Fasting (Behavioral)
结局指标
主要结局
Study feasability, measured by adequacy and efficiency of recruitment strategies
时间窗: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Number of participants recruited per month (at least 2 per month)
Study feasability, measured by adherence to the intervention and dropout rate
时间窗: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Adherence to the Intervention for intervention groups (at least 70% of the fasting cycles)
Study feasability, measured by acceptability of study outcome measures
时间窗: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Patient acceptability of study assessments (number of completed study visits)
Feasibility of the study procedures
时间窗: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of study procedures, e.g. in terms of patient and provider acceptance of randomisation and outcome measures (percentage of eligible participants who explicitly refuse to participate because of the randomization process, missing item-level data, completion rates of questionnaires)
Feasibility of the intervention procedures
时间窗: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of the intervention methods (including patient acceptance of video and telephone consultations measured by no-show rate, patient safety in terms of number of adverse events)
次要结局
- Adverse events(After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Hospitalizations rate(After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Dose Interruption or reduction(After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Cumulative dose(After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Treatment discontinuation(After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Subjective Severity of the main symptom(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Distress Thermometer(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Health status (EQ-5D-5L)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Short Form 36(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Quality of life of cancer patients (EORTC QLQ-C30)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Electrolytes(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Nutrition(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Differential blood count(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- C-reactive protein (CRP)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Alanine aminotransferase (ALT/ALAT)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Aspartate aminotransferase (AST/ASAT)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Creatinine(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Glucose(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- Lactate dehydrogenase (LDH)(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
- S100 protein(Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months)
研究者
Anika Hartmann Rajput, MD/PhD
MD/PhD, Department of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin, Clinician Scientist
Charite University, Berlin, Germany