Nutrition Intervention Among Stem Cell Recipients: Post Hospital Discharge
Condition: Hematopoietic Stem Cell Transplantation; Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nutrition Intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care