Childhood Brain TumorNCT02000986
Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
A study testing Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy in people with Childhood Brain Tumor and Childhood Hodgkin Lymphoma, run by Virginia Commonwealth University.
Trial summary
This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma
- What is being tested?
- Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 2015
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of pediatric cancer
- Patients 3 months to 1 year after completion of therapy
Who cannot join
- Patients who are already on antihypertensive or insulin or cholesterol lowering medication
- Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
- Inability to understand program instructions due to language barrier or mental disability
- Unable to participate in the outlined exercise program due to a physical disability
About this study
Official title: Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.
Read the detailed description
Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks.
After completion of study treatment, patients are followed for up to 6 months.
- Conditions
- Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma, Malignant Childhood Neoplasm
- Being tested
- Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
- Keywords
- Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified
- Medical subject headings
- Neoplasms, Hodgkin Disease, Neurologic Manifestations, Lymphoma, Non-Hodgkin, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> ChemotherapyBehavioural
Participants will be taught by a registered dietician about energy balance and how body weight relates to energy intake and expenditure, although specific calorie prescriptions will not be given. An exercise physiologist will create a personalized exercise plan and prescription which is tailored to his / her needs and current level of activity and fitness
| Study group | Role | What they receive |
|---|---|---|
| Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> | Experimental | Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy Receives: Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility determined by average attendance and retention
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Measured: At 3 months
Secondary outcomes (2)
Feasibility determined by average attendance and retention from the blood pressure at enrollment
Will be assessed via paired T test.
Measured: At 6 months
Acceptability level at time of enrollment
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2015
- Study completionJul 2015
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 Childhood Brain TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marieka A Helou, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000986
- Sponsor's protocol ID
- MCC-14062
- Other IDs
- HM14062
- Status last verified
- Nov 2015
- First submitted
- 26 Nov 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
- ClinicalTrials.gov ID
- NCT02000986
- Acronym / sponsor ID
- MCC-14062
- Conditions
- Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma, Malignant Childhood Neoplasm
- Keywords
- Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Dec 2013 (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 dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.
Detailed description
Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks.
After completion of study treatment, patients are followed for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> | Experimental | Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> ChemotherapySpecimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of pediatric cancer
- Patients 3 months to 1 year after completion of therapy
Key exclusion criteria (4 listed)
- Patients who are already on antihypertensive or insulin or cholesterol lowering medication
- Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
- Inability to understand program instructions due to language barrier or mental disability
- Unable to participate in the outlined exercise program due to a physical disability
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 |
|---|---|---|
| Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> ChemotherapyParticipants will be taught by a registered dietician about energy balance and how body weight relates to energy intake and expenditure, although specific calorie prescriptions will not be given. An exercise physiologist will create a personalized exercise plan and prescription which is tailored to his / her needs and current level of activity and fitness | Behavioural | Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> |
Primary outcome
Feasibility determined by average attendance and retention
Time frame: At 3 months
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
2 secondary outcomes
Feasibility determined by average attendance and retention from the blood pressure at enrollment
Time frame: At 6 months
Acceptability level at time of enrollment
Time frame: At 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Marieka A Helou, MD principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy in people with Childhood Brain Tumor and Childhood Hodgkin Lymphoma, run by Virginia Commonwealth University.
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 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: withdrawn, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 determined by average attendance and retention (time frame: At 3 months). 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 20 Nov 2015.