Hodgkin's LymphomaPhase 2NCT01699581
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
A Phase 2 study testing Nestle Impact Advanced Recovery in people with Hodgkin's Lymphoma and Multiple Myeloma, run by Greg Monohan at 1 site in United States.
Trial summary
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
- What is being tested?
- Nestle Impact Advanced Recovery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2
- Any prior diet or supplement will be allowed.
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.
- Conditions
- Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Being tested
- Nestle Impact Advanced Recovery
- Keywords
- Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Medical subject headings
- Hodgkin Disease, Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestle Impact Advanced RecoveryDietary supplement
dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Nestle Impact Advanced Recovery | Experimental | Nestle Impact Advanced Recovery
1 dose of Nestle Impact Advanced Recovery orally three times a day Receives: Dietary Supplement: Nestle Impact Advanced Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Days to engraftment
Measured: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionOct 2015
Why it stopped: Research cancelled following interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg Monohan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Greg Monohan, University of Kentucky
- Investigators
- Greg Monohan, MD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699581
- Sponsor's protocol ID
- 11-HEM-03-MCC
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT01699581
- Acronym / sponsor ID
- 11-HEM-03-MCC
- Conditions
- Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research cancelled following interim analysis
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Greg MonohanUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Oct 2012 (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.
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nestle Impact Advanced Recovery | Experimental | Dietary Supplement: Nestle Impact Advanced RecoveryNestle Impact Advanced Recovery 1 dose of Nestle Impact Advanced Recovery orally three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2
- Any prior diet or supplement will be allowed.
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (1 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
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 |
|---|---|---|
| Nestle Impact Advanced Recoverydose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge. | Dietary supplement | Nestle Impact Advanced Recovery |
Primary outcome
Hospital length of stay
Time frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Days to engraftment
Time frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Results and safety
The study was stopped early (reason given: Research cancelled following interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
Greg Monohan, MD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nestle Impact Advanced Recovery in people with Hodgkin's Lymphoma and Multiple Myeloma, run by Greg Monohan 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 4 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 18 Oct 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Research cancelled following interim analysis). 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?
Hospital length of stay (time frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge). The study lists 2 primary outcomes in all. 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 18 Oct 2016.