Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Conditions

• B-cell Acute Lymphoblastic Leukemia
• Obesity

Eligibility Criteria

Sex

ALL

Age

7 Years - 25 Years

Healthy Volunteers

Not accepted

Interventions

• IDEAL2 Intervention — BEHAVIORAL
  Intervention of diet and exercise to improve outcomes for ALL patients

Study Details

This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.

Key Dates

First listed

Oct 19, 2021

Start date

Mar 12, 2022

Status verified

Aug 2026

Primary completion

Aug 15, 2027

Completion

Aug 15, 2032

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: IDEAL2 intervention
  Focused and short-term intervention of diet and exercise during induction. Calorie goal is \>=15% daily deficit as determined by each subject's estimated energy requirement. Fat intake will make up \<25% of daily calories. Carbohydrate will make up \<55% of daily calories consisting of "low" glycemic load foods (\<100/2,000 kcal adjusted for daily calories). Protein will make up \>=20% of daily calories. Subjects will also perform moderate exercise 5 days per week for 30 minutes/session (total = 150 minutes per week). Subjects will have a step goal to decrease sedentary behavior, with a starting goal of \>=1000 steps/day and increasing by at least 1000 steps/day each week.
• No Intervention: Control - Standard of Care
  One-time education of diet and exercise, which is the standard of care for ALL patients during induction.

Primary Outcome Measure

EOI MRD positivity >= 0.01% [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]

Central Contacts

• Ellynore Florendo
  323-361-3022
  [email protected]
• Suganya Rajendran
  323-361-8835
  [email protected]

Locations (16)

Find similar trials in Los Angeles, CA

Related Studies

• Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
  Recruiting · University of Michigan · Ann Arbor, Michigan
• Investigating the Impact of Obesity on Pubertal Development in Girls
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• Inflammation, Diabetes, Ethnicity and Obesity Cohort
  Recruiting · University of California, San Francisco · San Francisco, California
• Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
  Recruiting · University of Colorado, Denver · Aurora, Colorado