Clinical trial NCT02708108: Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
Official title: Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: B Precursor Type Acute Leukemia
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Gabrielle's Angel Foundation
First posted: 2016-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study tests the ability of a focused dietary, exercise, and activity intervention to reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to improve disease response and reduce toxicity.

Detailed description: In our previous study, we have observed that: 1) nearly half ALL patients are overweight or obese at diagnosis, 2) all patients, regardless of starting weight, gain significant fat mass over the first month of therapy (on average 20-30%), and 3) obesity at the time of diagnosis is associated with a higher likelihood of poor response to chemotherapy as evidenced by persistent leukemia (minimal residual disease) after induction therapy. Together, these data show that body fat is a significant risk factor for ALL treatment failure, and that its negative effects are evident within the first month of treatment. Recent laboratory and clinical data illustrates the ability of diet restriction and physical activity to improve chemotherapy efficacy, reduce treatment-related toxicities and better overall quality of life.

Given the importance of successful induction therapy for ALL in predicting long term survival and the negative role of obesity on treatment success, this study tests a complete personalized dietary and exercise intervention for pre-adolescents, adolescents, and young adults newly diagnosed with B-precursor ALL ("pre-B ALL") that aims to reduce fat gained during induction therapy and thereby improve treatment response, toxicity rates, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 10 years of age and less than or equal to 21 years of age at time of diagnosis
* Have a new diagnosis of untreated NCI/Rome High Risk B-precursor ALL (HR-ALL)
* Are beginning treatment on- or as per- a Children's Cancer Group/Children's Oncology Group (CCG-COG) protocol with a 4-drug Induction including vincristine, daunorubicin (or doxorubicin), asparaginase, and at least 14 days of glucocorticoid steroids

Exclusion Criteria:

* Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal body composition
* Be underweight or "at risk for underweight" with moderate weight loss, defined as a starting Body Mass Index (BMI) \<10th percentile for age and sex (for those \>20 years of age, defined as an absolute BMI \< 18.5)
* Have pre-existing abnormal intestinal function (e.g. protein-wasting enteropathy, fat malabsorption)
* Be unable to comply with the recommended diet or activity interventions (as determined by study or treatment team)
* Have a history of prior chemotherapy or radiation for other cancers
* Be unable to complete the necessary radiology examinations with fully interpretable data (e.g. hip replacement and metal prostheses preclude evaluation by DXA)
* Be pregnant (to be confirmed by urine or serum pregnancy test as per institutional routine care for chemotherapy and radiology exams)

Primary outcomes:
measure: Fat Mass
timeFrame: Diagnosis and 28-35 days
Secondary outcomes:
measure: Percentage of Participants With Minimal Residual Disease >=0.01%
timeFrame: 28-35 days from diagnosis
measure: Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist
timeFrame: 28 days
measure: Percentage of Overall Adherence to the IDEAL Intervention
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Etan Orgel, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Steven D Mittelman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orgel E, Framson C, Buxton R, Kim J, Li G, Tucci J, Freyer DR, Sun W, Oberley MJ, Dieli-Conwright C, Mittelman SD. Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Blood Adv. 2021 Apr 13;5(7):1853-1861. doi: 10.1182/bloodadvances.2020004018.