NCT02791347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

June 1, 2016

Last Update Submit

February 7, 2018

Conditions

Hematopoietic Stem Cell TransplantationMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a PGSGA score ≥4

    100 days post transplantation

Secondary Outcomes (4)

  • Handgrip strength

    100 days post transplantation

  • Lean Body Mass Changes

    100 days post transplantation

  • Re-hospitalization Rate

    100 days post transplantation

  • Quality of life (QoL) [ Time Frame: 100 days post transplantation ]

    100 days post transplantation

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Nutrition InterventionOTHER
Nutrition Intervention Group

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Hematology Oncology- Department of Internal Medicine

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

LE(1)