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

Primary Purpose

B Precursor Type Acute Leukemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dietary Intervention

Activity and Exercise Intervention

About this trial

This is an interventional treatment trial for B Precursor Type Acute Leukemia

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Childrens Hospital Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obesity Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Fat Mass

Assessment of change in fat 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. Calculated as (Day 28 Fat Mass - Diagnosis Fat Mass)/Diagnosis Fat Mass

Secondary Outcome Measures

Percentage of Participants With Minimal Residual Disease >=0.01%

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

Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist

Assess feasibility of incorporating the intervention into induction chemotherapy as defined by >80% of overall scheduled study visits successfully completed. The expected number of overall visits is equal to the sum of total visits scheduled with the physiotherapist (PT) or the registered dietitian (RD). The measure was calculated as the total # expected visits/completed visits.

Percentage of Overall Adherence to the IDEAL Intervention

Overall adherence to the study intervention was calculated as the mean of dietary adherence (average of percent consumed calories/prescribed calories for each food group) and activity (self-reported % adherence to prescribed days).

Full Information

NCT ID

NCT02708108

First Posted

March 7, 2016

Last Updated

March 27, 2023

Sponsor

Children's Hospital Los Angeles

Collaborators

Gabrielle's Angel Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02708108

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital Los Angeles

Collaborators

Gabrielle's Angel Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B Precursor Type Acute Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Obesity Intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Dietary Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Activity and Exercise Intervention

Intervention Description

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 Measure Information:

Title

Fat Mass

Description

Time Frame

Diagnosis and 28-35 days

Secondary Outcome Measure Information:

Title

Percentage of Participants With Minimal Residual Disease >=0.01%

Description

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

Time Frame

28-35 days from diagnosis

Title

Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist

Description

Time Frame

28 days

Title

Percentage of Overall Adherence to the IDEAL Intervention

Description

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Etan Orgel, MD MS

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven D Mittelman, MD PhD

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Childrens Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33792627

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.

Results Reference

derived

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

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