MalnutritionCONSEPTNCT02734797
Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
An observational study of Malnutrition and Obesity, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Malnutrition, Obesity
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2016to 10 Feb 2020
- Phase
- Observational
- 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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric hematopoietic cell transplant patients
Who may be able to join
- Pediatric hematopoietic cell transplant patients, aged 2-25 years.
- Participants and/or at least one caregiver must speak, read and understand English.
Who cannot join
- Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.
- Conditions
- Malnutrition, Obesity
- Medical subject headings
- Malnutrition, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of comprehensive nutrition assessments in pediatric HCT patients
Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.
Measured: 1 year post-HCT
Secondary outcomes (6)
Dietary intake
Measured: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Determination of lean body mass measured using air displacement plethysmography (BOD POD)
Measured: baseline (pre-HCT); day 100 and 1 year post-HCT
Hand grip strength
Measured: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Pediatric Quality of Life Inventory
Participants 10 years or older
Measured: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Cognitive Functioning Scale
Participants 10 years or older
Measured: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Dietary Patient Self-Efficacy Survey
Participants 10 years or older
Measured: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start9 Mar 2016
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734797
- Sponsor's protocol ID
- UMCC 2015.108
- Other IDs
- HUM00102331
- Acronym
- CONSEPT
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2016
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
- ClinicalTrials.gov ID
- NCT02734797
- Acronym / sponsor ID
- CONSEPT / UMCC 2015.108
- Conditions
- Malnutrition, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 12 Apr 2016 (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.
Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | –This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric hematopoietic cell transplant patients
Key inclusion criteria (2 listed)
- Pediatric hematopoietic cell transplant patients, aged 2-25 years.
- Participants and/or at least one caregiver must speak, read and understand English.
Key exclusion criteria (1 listed)
- Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of comprehensive nutrition assessments in pediatric HCT patients
Time frame: 1 year post-HCT
Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.
6 secondary outcomes
Dietary intake
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Determination of lean body mass measured using air displacement plethysmography (BOD POD)
Time frame: baseline (pre-HCT); day 100 and 1 year post-HCT
Hand grip strength
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Pediatric Quality of Life Inventory
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Cognitive Functioning Scale
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Dietary Patient Self-Efficacy Survey
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
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 25 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Obesity, run by University of Michigan Rogel 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 2 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: finished, as of the sponsor's last update on 25 Jan 2024. 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 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?
Feasibility of comprehensive nutrition assessments in pediatric HCT patients (time frame: 1 year post-HCT). 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 25 Jan 2024.