Malignant NeoplasmNCT02590107
Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant
A study testing Boost Plus, Pro-Stat 101 and Milkshake in people with Malignant Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Boost Plus, Pro-Stat 101 and Milkshake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Malignant Neoplasm
- Being tested
- Boost Plus, Pro-Stat 101, Milkshake, daily food diaries
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost PlusDietary supplement
Also called Supplementation
Receive nutritional supplementation twice daily to provide 28g of protein
Pro-Stat 101Dietary supplement
Also called Supplementation
Receive nutritional supplementation twice daily to provide 30g of protein
MilkshakeDietary supplement
Also called Supplementation
Receive alternate nutritional supplementation once daily to provide 28g protein
daily food diariesOther
Also called food diary, food intake form
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
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Boost Plus, Pro-Stat 101) | Experimental | 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. Receives: Dietary Supplement: Boost Plus; Dietary Supplement: Pro-Stat 101; Dietary Supplement: Milkshake; Other: daily food diaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
To test the improvement of nutritional status over a period of time, a linear mixed model will be fit and the PG-SGA trend will be tested.
Measured: Baseline to time of hospital discharge, up to 1 year
Secondary outcomes (5)
Length of hospital stay, defined by time of admission through discharge
Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients.
Measured: Up to time of hospital discharge, up to 1 year
Change in serum albumin
Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients.
Measured: Baseline, up to time of hospital discharge, up to 1 year
Change in serum 25-hydroxy vitamin D
Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients.
Measured: Baseline, up to time of hospital discharge, up to 1 year
Degree of mucositis
Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients.
Measured: Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks
Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500
Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients.
Measured: Up to time of hospital discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start1 Apr 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Autumn Diligente, MS, RDN, LD, Study director, Case Comprehensive Cancer CenterStephanie Logosh, MS, RDN, LD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590107
- Sponsor's protocol ID
- CASE6Z14
- Other IDs
- NCI-2015-00477, CASE6Z14, P30CA043703
- Status last verified
- May 2018
- First submitted
- 27 Oct 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT02590107
- Acronym / sponsor ID
- CASE6Z14
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Boost Plus, Pro-Stat 101) | Experimental | Dietary Supplement: Boost Plus, Dietary Supplement: Pro-Stat 101, Dietary Supplement: Milkshake, Other: daily food diariesParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boost PlusAlso: SupplementationReceive nutritional supplementation twice daily to provide 28g of protein | Dietary supplement | Supportive care (Boost Plus, Pro-Stat 101) |
| Pro-Stat 101Also: SupplementationReceive nutritional supplementation twice daily to provide 30g of protein | Dietary supplement | Supportive care (Boost Plus, Pro-Stat 101) |
| MilkshakeAlso: SupplementationReceive alternate nutritional supplementation once daily to provide 28g protein | Dietary supplement | Supportive care (Boost Plus, Pro-Stat 101) |
| daily food diariesAlso: food diary, food intake formParticipants 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 | Other | Supportive care (Boost Plus, Pro-Stat 101) |
Primary outcome
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: Baseline to time of hospital discharge, up to 1 year
To test the improvement of nutritional status over a period of time, a linear mixed model will be fit and the PG-SGA trend will be tested.
5 secondary outcomes
Length of hospital stay, defined by time of admission through discharge
Time frame: Up to time of hospital discharge, up to 1 year
Change in serum albumin
Time frame: Baseline, up to time of hospital discharge, up to 1 year
Change in serum 25-hydroxy vitamin D
Time frame: Baseline, up to time of hospital discharge, up to 1 year
Degree of mucositis
Time frame: Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks
Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500
Time frame: Up to time of hospital discharge, up to 1 year
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Autumn Diligente, MS, RDN, LD study director
Case Comprehensive Cancer Center
Stephanie Logosh, MS, RDN, LD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost Plus, Pro-Stat 101 and Milkshake in people with Malignant Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) (time frame: Baseline to time of hospital discharge, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.