Nutrition Intervention Among Stem Cell Recipients: Post Hospital Discharge

February 7, 2018 updated by: Jean El Sheikh, American University of Beirut Medical Center

Nutrition Intervention Among Stem Cell Recipients: a Randomized Controlled Trial Post Hospital Discharge

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: Nutrition Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with a PGSGA score ≥4
Time Frame: 100 days post transplantation
100 days post transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Handgrip strength
Time Frame: 100 days post transplantation
100 days post transplantation
Lean Body Mass Changes
Time Frame: 100 days post transplantation
100 days post transplantation
Re-hospitalization Rate
Time Frame: 100 days post transplantation
100 days post transplantation
Quality of life (QoL) [ Time Frame: 100 days post transplantation ]
Time Frame: 100 days post transplantation
100 days post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

Aix Marseille Université

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM.J-EC.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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