An Early Phase 1 interventional study of Counseling and Exercise Intervention in Leukemia and Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by M.D. Anderson Cancer Center · Early Phase 1, Interventional, and Supportive care
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.
Other: Counseling · Other: Informational Intervention · Other: Questionnaire Administration
Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.
Behavioral: Exercise Intervention · Dietary Supplement: Nutritional Intervention · Other: Questionnaire Administration
Attend nutrition counseling sessions
Also known as: Counseling Intervention
Complete PA sessions
Receive nutrition handouts
Attend tasting sessions
Ancillary studies
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.
Time frame: through study completion an average of 1 year
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center