Nutrition Intervention Among Stem Cell Recipients: a Randomized Controlled Trial Post Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Proportion of patients with a PGSGA score ≥4
研究概览
简要总结
Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated with severe gastrointestinal toxicity, commonly compromising patients' food intake, nutritional status and functioning level. Malnutrition has been associated with worse functional status, reduced survival, increased rate of infections, complications, hospitalizations, and therapy toxicity in oncology patients.
To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The proposed study is a single center, prospective, RCT with a parallel design that aims to assess the impact of a nutrition intervention on the nutritional and functional statuses of SCT recipients 100 days post SCT.
详细描述
This study is a single center RCT with a parallel design. It aims to improve the SCT recipients' nutritional status and QoL and reduce the associated morbidities. Results of the study can guide the recommendations for the medical and nutritional outpatient assessment post SCT.
During the pre-SCT workup, patients will be invited to participate in the study. Around discharge from the hospital, recruited patients will be randomized to a control or an intervention group based on permuted block random sampling. Patients in the Nutrition Intervention group (NIG) will receive a tailored diet plan from the dietitian as well as regular outpatient follow-ups measuring and reinforcing compliance. Patients in the Control Group (CG) will receive usual care; they will only be assessed in the nutrition clinics upon referral by the medical team. The body composition, Quality of Life (QoL), Physical Activity (PA) level, nutrient intake, functional status and nutritional status of both groups will be evaluated at regular intervals during the hospital stay and post discharge through the Patient Generated Subjective Global Assessment (PGSGA), Body Impedance Analysis (BIA), handgrip strength, Functional Assessment of Cancer Therapy -Bone Marrow Transplantation (FACT-BMT), PA questionnaire and Karnofsky scale. Moreover, patients' food intake will be analyzed for its micronutrient and macronutrient content to assess the changes in nutrient analysis in the peri-transplantation phase. When applicable, BIA and Computed Tomography (CT) tests will be compared for their agreements.
Considering a power of 80%, an attrition rate of 30% and a difference of 40% between the NIG and CG groups, 52 patients need to be recruited in the study. Analysis will be done based on 'intention to treat' and 'per protocol' analysis.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults admitted to the adult BMT service at AUBMC
- •Allogeneic or autologous SCT
- •Malignant or non-malignant indication for SCT
排除标准
- •Patients who pass away before day +100
- •Patients who miss 2 assessment points
研究组 & 干预措施
Control
Upon discharge from the medical center, patients would be advised on a qualitative, neutropenic diet. Participants' quality of life, physical activity level, functional and nutritional status would be assessed at days +30, +60 and +100 post transplantation.
These participants will not receive nutritional counseling by the dietitian as outpatients except if referred by the medical team.
Nutrition Intervention Group
Upon discharge from the medical center, NIG patients will receive tailored nutrition counseling with the provision of patient education material and oral nutritional supplements if needed. Patients will be advised on a diet high in energy and proteins and tailored to their medical condition in the hospital before discharge.
Patients will be followed up at days +30, +60 and +100 post transplantation. Compliance will be measured at each visit by comparing patients caloric and protein needs to their actual protein and energy intake. Compliance will be reinforced to meet patients' goals using nutritional tips, oral supplementation, and artificial nutrition use.
干预措施: Nutrition Intervention (Other)
结局指标
主要结局
Proportion of patients with a PGSGA score ≥4
时间窗: 100 days post transplantation
次要结局
- Re-hospitalization Rate(100 days post transplantation)
- Handgrip strength(100 days post transplantation)
- Lean Body Mass Changes(100 days post transplantation)
- Quality of life (QoL) [ Time Frame: 100 days post transplantation ](100 days post transplantation)
研究者
Jean El Sheikh
Assistant Professor of Hematology Oncology- Department of Internal Medicine
American University of Beirut Medical Center