M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT05049785
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.
Looking for future studies?
Notify Me7 year–18 year
All sexes
Interventional
Early Phase 1
Houston, Texas, 77030, United States
PRIMARY OBJECTIVES:
I. 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:
I. 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.
V. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attend nutrition counseling sessions
Other names: Counseling Intervention
Complete PA sessions
Receive nutrition handouts
Attend tasting sessions
Ancillary studies
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.
M.D. Anderson Cancer Center
Other
Nutrition Intervention for Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06026046
Hematologic Diseases, Hemic and Lymphatic Diseases
Angers, France
View Trial DetailsNCT05763563
Hematologic Diseases, Hemic and Lymphatic Diseases
Tampa, Florida, United States
View Trial DetailsNCT01315132
Blood Protein Disorders, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04026737
Cardiotoxicity, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial Details