Clinical trial NCT02791347: Nutrition Intervention Among Stem Cell Recipients: Post Hospital Discharge
Official title: Nutrition Intervention Among Stem Cell Recipients: a Randomized Controlled Trial Post Hospital Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Malnutrition
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Aix Marseille Université
First posted: 2016-06-06
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults admitted to the adult BMT service at AUBMC
* Allogeneic or autologous SCT
* Malignant or non-malignant indication for SCT

Exclusion Criteria:

* Patients who pass away before day +100
* Patients who miss 2 assessment points

Primary outcomes:
measure: Proportion of patients with a PGSGA score ≥4
timeFrame: 100 days post transplantation
Secondary outcomes:
measure: Handgrip strength
timeFrame: 100 days post transplantation
measure: Lean Body Mass Changes
timeFrame: 100 days post transplantation
measure: Re-hospitalization Rate
timeFrame: 100 days post transplantation
measure: Quality of life (QoL) [ Time Frame: 100 days post transplantation ]
timeFrame: 100 days post transplantation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References: