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Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)

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ClinicalTrials.gov Identifier: NCT02708108
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Gabrielle's Angels Foundation for Cancer Research
Information provided by (Responsible Party):
Etan Orgel, Children's Hospital Los Angeles

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.

Condition or disease Intervention/treatment Phase
B Precursor Type Acute Leukemia Behavioral: Dietary Intervention Behavioral: Activity and Exercise Intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Obesity Intervention
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Behavioral: Dietary Intervention
Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.

Behavioral: Activity and Exercise Intervention
Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.




Primary Outcome Measures :
  1. Body Fat [ Time Frame: +28-35 days ]
    Assessment of change in body fat and lean muscle mass before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort.


Secondary Outcome Measures :
  1. Assessment of Minimal Residual Disease [ Time Frame: +28-35 days ]
    Compare the rate of minimal residual disease "positivity" (defined as >=0.01%) in the bone marrow by flow cytometry after the induction phase of chemotherapy as compared to a recent historical cohort

  2. Feasibility [ Time Frame: 28 days ]
    Assess feasibility of incorporating the intervention into induction chemotherapy as defined by >80% of scheduled visits overall and with the PT and RD (# completed visits/# scheduled visits)

  3. Adherence [ Time Frame: 28 days ]
    Assess adherence to the diet and activity components of the intervention defined by >75% adherence to the recommended diet changes (daily calories prescribed/intake, and % food group prescribed/ intake) and activity (prescribed minutes/actual minutes and prescribed metabolic equivalents/actual metabolic equivalents).



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708108


Contacts
Contact: Stephanie Garcia 323-361-8897 stegarcia@chla.usc.edu
Contact: Lakshmi Damerla 323-361-8359 ldamerla@chla.usc.edu

Locations
United States, California
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Stephanie Garcia    323-361-8897    stegarcia@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
Gabrielle's Angels Foundation for Cancer Research
Investigators
Principal Investigator: Etan Orgel, MD MS Children's Hospital Los Angeles
Principal Investigator: Steven D Mittelman, MD PhD Children's Hospital Los Angeles

Responsible Party: Etan Orgel, Assistant Professor of Clinical Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02708108     History of Changes
Other Study ID Numbers: CCI-14-00073
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases