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

NCT ID: NCT02708108

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-12-30

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.

Conditions

B Precursor Type Acute Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: BEHAVIORAL

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.

Activity and Exercise Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gabrielle's Angel Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Etan Orgel

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Etan Orgel, MD MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Steven D Mittelman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33792627 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CCI-14-00073

Identifier Type: -

Identifier Source: org_study_id