Melphalan Autologous TransplantPhase 1NCT03449927
Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
A Phase 1 study testing Specialized menu, Self report dietary intake worksheet and Post study questionnaire in people with Melphalan Autologous Transplant, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melphalan Autologous Transplant
- What is being tested?
- Specialized menu, Self report dietary intake worksheet and Post study questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 27 Feb 2018
- Phase
- Phase 1
- 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 undergoing melphalan autologous transplants will be included in this study
- All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
- Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
- Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.
Who cannot join
- Patients <18 years of age
- Pregnant women
- Prisoners
- Patient unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Study of Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.
- Conditions
- Melphalan Autologous Transplant
- Being tested
- Specialized menu, Standard of care menu, Self report dietary intake worksheet, Post study questionnaire
- Keywords
- Nutrition Tool, Melphalan Autologous Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized menuOther
-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea
Standard of care menuOther
-Standard registered dietitian support
Self report dietary intake worksheetOther
-Self report nausea and diarrhea
Post study questionnaireOther
-Completed upon count recovery and prior to discharge
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Regular menu | Active comparator | * Calorie count initiated on day +1 of transplant and ending upon count recovery
* Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
* Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
* Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians Receives: Other: Standard of care menu; Other: Self report dietary intake worksheet; Other: Post study questionnaire |
| Intervention Arm: Specialized Menu | Experimental | * Calorie count and tool provided on day +1 and ending upon count recovery
* Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
* Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
* Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise Receives: Other: Specialized menu; Other: Self report dietary intake worksheet; Other: Post study questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post intervention mean total caloric intake
Measured: Through count recovery (10 days)
Mean total protein intake
Measured: Through count recovery (10 days)
Secondary outcomes (2)
Mean daily caloric intake
Measured: Through count recovery (10 days)
Mean daily protein intake
Measured: Through count recovery (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Jan 2018
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melphalan Autologous TransplantStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Kathleen Stockmann, MS, RD, LD, Principal investigator, Washington University School of MedicineMeaghan Ryan, MSN, FNP-BC, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449927
- Sponsor's protocol ID
- 201711044
- Status last verified
- Mar 2019
- First submitted
- 22 Feb 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
- ClinicalTrials.gov ID
- NCT03449927
- Acronym / sponsor ID
- 201711044
- Conditions
- Melphalan Autologous Transplant
- Keywords
- Nutrition Tool, Melphalan Autologous Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 28 Feb 2018 (actual)
- 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.
The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Regular menu | Active comparator | Other: Standard of care menu, Other: Self report dietary intake worksheet, Other: Post study questionnaire* Calorie count initiated on day +1 of transplant and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians |
| Intervention Arm: Specialized Menu | Experimental | Other: Specialized menu, Other: Self report dietary intake worksheet, Other: Post study questionnaire* Calorie count and tool provided on day +1 and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise |
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 undergoing melphalan autologous transplants will be included in this study
- All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
- Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
- Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.
Key exclusion criteria (4 listed)
- Patients <18 years of age
- Pregnant women
- Prisoners
- Patient unable to provide informed consent.
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 |
|---|---|---|
| Specialized menu-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea | Other | Intervention Arm: Specialized Menu |
| Standard of care menu-Standard registered dietitian support | Other | Control Arm: Regular menu |
| Self report dietary intake worksheet-Self report nausea and diarrhea | Other | Control Arm: Regular menu, Intervention Arm: Specialized Menu |
| Post study questionnaire-Completed upon count recovery and prior to discharge | Other | Control Arm: Regular menu, Intervention Arm: Specialized Menu |
Primary outcome
Pre and post intervention mean total caloric intake
Time frame: Through count recovery (10 days)
Mean total protein intake
Time frame: Through count recovery (10 days)
2 secondary outcomes
Mean daily caloric intake
Time frame: Through count recovery (10 days)
Mean daily protein intake
Time frame: Through count recovery (10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kathleen Stockmann, MS, RD, LD principal investigator
Washington University School of Medicine
Meaghan Ryan, MSN, FNP-BC principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Specialized menu, Self report dietary intake worksheet and Post study questionnaire in people with Melphalan Autologous Transplant, run by Washington University School of Medicine 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 4 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: finished, as of the sponsor's last update on 13 Mar 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre and post intervention mean total caloric intake (time frame: Through count recovery (10 days)). 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 13 Mar 2019.