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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients

NCT04591340

Nutrition Related Cancer

UNKNOWN

Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

NCT03563352

Breast Carcinoma Cholangiocarcinoma Colorectal Carcinoma +4 more

WITHDRAWN

Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer

NCT06671613

Stage IV NSCLC NSCLC Immunotherapy +1 more

RECRUITING NA

Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery

NCT04029857

Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 +12 more

WITHDRAWN PHASE3

Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)

NCT03700437

Non-small Cell Lung Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supportive care (Boost Plus, Pro-Stat 101)

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.

Group Type EXPERIMENTAL

Boost Plus

Intervention Type DIETARY_SUPPLEMENT

Receive nutritional supplementation twice daily to provide 28g of protein

Pro-Stat 101

Intervention Type DIETARY_SUPPLEMENT

Receive nutritional supplementation twice daily to provide 30g of protein

Milkshake

Intervention Type DIETARY_SUPPLEMENT

Receive alternate nutritional supplementation once daily to provide 28g protein

daily food diaries

Intervention Type OTHER

Participants will be given a food intake form, clipboard, and pen to record specific foods, as well as amounts of foods that are consumed from outside sources. In addition, the specific food items that each participant consumes will be recorded by the participant on his or her meal tickets which are included with each meal tray

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Boost Plus

Receive nutritional supplementation twice daily to provide 28g of protein

Intervention Type DIETARY_SUPPLEMENT

Pro-Stat 101

Receive nutritional supplementation twice daily to provide 30g of protein

Intervention Type DIETARY_SUPPLEMENT

Milkshake

Receive alternate nutritional supplementation once daily to provide 28g protein

Intervention Type DIETARY_SUPPLEMENT

daily food diaries

Participants will be given a food intake form, clipboard, and pen to record specific foods, as well as amounts of foods that are consumed from outside sources. In addition, the specific food items that each participant consumes will be recorded by the participant on his or her meal tickets which are included with each meal tray

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Supplementation Supplementation Supplementation food diary food intake form

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No