The Effect of Individualized NUTritional Counselling on Muscle Mass and Treatment Outcome in Patients With Metastatic COLOrectal Cancer Undergoing Chemotherapy: the COLONUT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 10
- 主要终点
- Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
研究概览
简要总结
The purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied.We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling.
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
- Single (Care Provider)
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
- •Stage IV colorectal cancer
- •Scheduled for treatment with first line chemotherapy, either CAPOX(-B), FOLFOX(-B) or capecitabine(-B)
- •CT scan suitable for evaluating muscle mass at L3 level
- •Understanding of the Dutch language
- •Able and willing to give written informed consent
排除标准
- •Chemotherapy in the previous three months
- •WHO performance status ≥ 3
- •Long-term high dose of corticosteroids: ≥ three weeks ≥ ten milligram prednisolon or equivalent
研究组 & 干预措施
Nutritional counseling
Individualized nutritional counselling by a registered dietitian
干预措施: Nutritional counseling (Procedure)
No intervention
Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.
结局指标
主要结局
Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
时间窗: During 9 weeks of first line chemotherapy
will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes
次要结局
- Change in total body lean body mass and segmental lean body mass (DEXA) in patients with stage IV colorectal cancer during 9 weeks of first line chemotherapy between individualized nutritional counseling versus usual nutritional care(During 9 weeks of first line chemotherapy)
- Change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first line chemotherapy between individualized nutritional counseling.versus usual nutritional care.(During 20 weeks of first line chemotherapy)
- Associations of (changes in) muscle area with (changes in) mid-upper arm muscle circumference, whole body fat free mass (BIA) and whole body lean body mass (DEXA).(During 9 weeks of first line chemotherapy)
- Composite of treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and hand grip strength of both study arms(During 9 weeks and during 20 weeks of first line chemotherapy)
研究者
M.A.E van Bokhorst - de van der Schueren, Dr.
Senior Investigator dietetics and nutrition sciences Vumc
Amsterdam UMC, location VUmc