LeukemiaEarly Phase 1NCT05049785
Nutrition and Physical Activity Intervention in Preventing Excess Weight Gain in Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone
A Early Phase 1 study testing Counseling, Exercise Intervention and Informational Intervention in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- What is being tested?
- Counseling, Exercise Intervention and Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2011to 21 Jul 2025
- Phase
- Early 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital
- Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital at time of enrollment
- Karnofsky performance status greater than or equal to 70
- Must be cleared by treating oncologist to participate in study
- Must live close enough to attend measurement sessions at one of the clinical centers
Who cannot join
- Patients receiving nutrition counseling or weight management counseling elsewhere
- Pediatric patients who are already receiving steroids that are not part of treatment
- History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Intervention for Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone
This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
SECONDARY OBJECTIVES:
- To conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods.
II. To conduct qualitative research on exercise habits and willingness to engage in moderate walking.
III. To assess receptivity to electronic dietary and physical activity (PA) interventions in pediatric cancer patients and survivors (PCPSs) and their parents.
IV. To determine if nutrition interventions will prevent an increase in body mass index (BMI) from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
- To determine if a nutrition counseling intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin A1C and improve absolute lymphocyte counts (ALC) from baseline measurements for pediatric leukemia or lymphoma patients, receiving prednisone and/or dexamethasone therapy.
VI. To evaluate caloric intake, nutritional parameters and oxidative stress in pediatric leukemia or lymphoma patients receiving prednisone and/or dexamethasone therapy.
VII. To evaluate responses to various energy balance interventions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.
ARM II: Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.
- Being tested
- Counseling, Exercise Intervention, Informational Intervention, Nutritional Intervention, Questionnaire Administration
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Attend nutrition counseling sessions
Exercise InterventionBehavioural
Complete PA sessions
Informational InterventionOther
Receive nutrition handouts
Nutritional InterventionDietary supplement
Attend tasting sessions
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (counseling) | Active comparator | Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts. Receives: Other: Counseling; Other: Informational Intervention; Other: Questionnaire Administration |
| Arm II (nutrition and PA intervention) | Experimental | Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session. Receives: Behavioral: Exercise Intervention; Dietary Supplement: Nutritional Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference
Will assess the difference in waist circumferences between patients in the Arm 1 intervention group compared to patients in the Arm 1 control group. The primary analysis will use the two-sample t-tests, and will be conducted on the intent-to-treat basis. This implies that if patients in the control arm received nutrition counseling, that patient will still be labeled as control.
Measured: through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start12 May 2011
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joya Chandra, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049785
- Sponsor's protocol ID
- 2010-0654
- Other IDs
- NCI-2019-02456, 2010-0654
- Status last verified
- Jul 2025
- First submitted
- 9 Sep 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention for Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone
- ClinicalTrials.gov ID
- NCT05049785
- Acronym / sponsor ID
- 2010-0654
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 May 2011 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 20 Sep 2021 (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.
This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
SECONDARY OBJECTIVES:
- To conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods.
II. To conduct qualitative research on exercise habits and willingness to engage in moderate walking.
III. To assess receptivity to electronic dietary and physical activity (PA) interventions in pediatric cancer patients and survivors (PCPSs) and their parents.
IV. To determine if nutrition interventions will prevent an increase in body mass index (BMI) from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
- To determine if a nutrition counseling intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin A1C and improve absolute lymphocyte counts (ALC) from baseline measurements for pediatric leukemia or lymphoma patients, receiving prednisone and/or dexamethasone therapy.
VI. To evaluate caloric intake, nutritional parameters and oxidative stress in pediatric leukemia or lymphoma patients receiving prednisone and/or dexamethasone therapy.
VII. To evaluate responses to various energy balance interventions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.
ARM II: Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (counseling) | Active comparator | Other: Counseling, Other: Informational Intervention, Other: Questionnaire AdministrationPatients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts. |
| Arm II (nutrition and PA intervention) | Experimental | Behavioral: Exercise Intervention, Dietary Supplement: Nutritional Intervention, Other: Questionnaire AdministrationPatients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital
- Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital at time of enrollment
- Karnofsky performance status greater than or equal to 70
- Must be cleared by treating oncologist to participate in study
- Must live close enough to attend measurement sessions at one of the clinical centers
Key exclusion criteria (3 listed)
- Patients receiving nutrition counseling or weight management counseling elsewhere
- Pediatric patients who are already receiving steroids that are not part of treatment
- History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
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 |
|---|---|---|
| CounselingAlso: Counseling InterventionAttend nutrition counseling sessions | Other | Arm I (counseling) |
| Exercise InterventionComplete PA sessions | Behavioural | Arm II (nutrition and PA intervention) |
| Informational InterventionReceive nutrition handouts | Other | Arm I (counseling) |
| Nutritional InterventionAttend tasting sessions | Dietary supplement | Arm II (nutrition and PA intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (counseling), Arm II (nutrition and PA intervention) |
Primary outcome
Change in waist circumference
Time frame: through study completion an average of 1 year
Will assess the difference in waist circumferences between patients in the Arm 1 intervention group compared to patients in the Arm 1 control group. The primary analysis will use the two-sample t-tests, and will be conducted on the intent-to-treat basis. This implies that if patients in the control arm received nutrition counseling, that patient will still be labeled as control.
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 Jul 2025.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Joya Chandra principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Counseling, Exercise Intervention and Informational Intervention in people with Leukemia and Lymphoma, run by M.D. Anderson 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 5 inclusion and 3 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 Jul 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in waist circumference (time frame: through study completion an average of 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 25 Jul 2025.