Clinical trial NCT02590107: Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant
Official title: The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies the use of early oral supplementation in improving nutritional status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional status in participants undergoing hematopoietic stem cell transplant has been linked to decreased outcomes such as increased length of hospital stay and increased time to engraftment (an important milestone in transplant recovery). Early oral supplementation may increase nutritional status and help to promote a positive outcome in participants undergoing transplant.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if early oral supplementation improves nutritional status, decreases length of hospital stay, and shortens time to engraftment of hematopoietic stem cell transplant (HSCT) participants.

SECONDARY OBJECTIVES:

I. Serum albumin, serum 25-hydroxy vitamin D, and the degree of mucositis, as scored by the National Cancer Institute's Common Toxicity Criteria (NCI-CTC), a validated and widely accepted scale used for rating mucositis. The purpose of our secondary aims is to observe a potential correlation between the retrospective and prospective groups, as well as assess the need for future research based on these correlations.

OUTLINE:

Participants receive Boost Plus orally (PO) twice daily (BID) or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO once daily (QD) as an alternative.

Eligibility criteria: Inclusion Criteria:

* Undergoing an autologous or reduced intensity conditioning (RIC) allogeneic HSCT
* A serum albumin greater than or equal to 2.5 g/dL
* Able to understand and sign consent

Exclusion Criteria:

* Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease

Primary outcomes:
measure: Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: Baseline to time of hospital discharge, up to 1 year
Secondary outcomes:
measure: Length of hospital stay, defined by time of admission through discharge
timeFrame: Up to time of hospital discharge, up to 1 year
measure: Change in serum albumin
timeFrame: Baseline, up to time of hospital discharge, up to 1 year
measure: Change in serum 25-hydroxy vitamin D
timeFrame: Baseline, up to time of hospital discharge, up to 1 year
measure: Degree of mucositis
timeFrame: Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks
measure: Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500
timeFrame: Up to time of hospital discharge, up to 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Autumn Diligente, MS, RDN, LD
role: STUDY_DIRECTOR
affiliation: Case Comprehensive Cancer Center
name: Stephanie Logosh, MS, RDN, LD
role: PRINCIPAL_INVESTIGATOR
References: