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Corticosteroid

Nutrition and Exercise Plan for Leukemia/Lymphoma

N/A
Waitlist Available
Led By Joya Chandra
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 not have
Pediatric patients who are already receiving steroids that are not part of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a nutrition and activity plan to help kids with leukemia/lymphoma avoid weight gain from prednisone/dexamethasone.

Who is the study for?
This trial is for pediatric leukemia or lymphoma patients at MD Anderson Children's Cancer Hospital who are currently being treated with prednisone and/or dexamethasone. Participants must have a good performance status, be cleared by their oncologist, and live close enough to attend sessions. Those already getting nutrition/weight counseling or on non-treatment steroids, or with certain psychological disorders can't join.
What is being tested?
The study is testing whether a program of nutritional guidance and physical activity can prevent kids receiving steroid treatment for leukemia or lymphoma from gaining too much weight. It involves exercise routines, dietary advice, educational materials about health habits, and regular questionnaires.
What are the potential side effects?
Since the interventions include lifestyle changes like diet modification and increased exercise rather than medication, side effects may be minimal but could include typical exercise-related injuries or stress if not properly supervised.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking prednisone or dexamethasone at MD Anderson Children's Cancer Hospital.
Select...
I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a child taking steroids not related to my cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in waist circumference

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (nutrition and PA intervention)Experimental Treatment3 Interventions
Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.
Group II: Arm I (counseling)Active Control3 Interventions
Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Nutritional Intervention
2011
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,145 Total Patients Enrolled
464 Trials studying Leukemia
31,699 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,901 Total Patients Enrolled
1,534 Trials studying Leukemia
385,471 Patients Enrolled for Leukemia
Joya ChandraPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05049785 — N/A
Leukemia Research Study Groups: Arm I (counseling), Arm II (nutrition and PA intervention)
Leukemia Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05049785 — N/A
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049785 — N/A
~14 spots leftby Feb 2027
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