Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Malignant Neoplasm

Treatments: Dietary Supplement: Boost Plus; Other: daily food diaries; Dietary Supplement: Milkshake; Dietary Supplement: Pro-Stat 101

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02590107

CASE6Z14 (Other Identifier)

NCI-2015-00477 (Registry Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Supportive care (Boost Plus, Pro-Stat 101)

Experimental group

Description:

Participants receive Boost Plus PO 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 QD as an alternative.

Treatment:

Dietary Supplement: Pro-Stat 101

Dietary Supplement: Milkshake

Other: daily food diaries

Dietary Supplement: Boost Plus