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

NCT02708108 | Completed Results

• 1 other identifier: CCI-14-00073
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

B Precursor Type Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

  Diagnosis and 28-35 days

Secondary Outcomes (3)

• Percentage of Participants With Minimal Residual Disease >=0.01%

  28-35 days from diagnosis

• Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist

  28 days

• Percentage of Overall Adherence to the IDEAL Intervention

  28 days

Study Arms (1)

Obesity Intervention

EXPERIMENTAL

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; Behavioral: Activity and Exercise Intervention

Interventions

Dietary Intervention 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.

Obesity Intervention

Activity and Exercise Intervention 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.

Obesity Intervention

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Gabrielle's Angel Foundation: collaborator

Study Sites (1)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (1)

• 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.

  PMID: 33792627 DERIVED

MeSH Terms

Interventions

Diet Therapy; Exercise

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Adverse event reporting was not available from the historical cohort for comparison with the IDEAL cohort.

Results Point of Contact

• Title: Dr Etan Orgel
• Organization: Childrens Hospital Los Angeles

eorgel@chla.usc.edu

13233612121

Study Officials

• Etan Orgel, MD MS

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Steven D Mittelman, MD PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 15, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: December 30, 2019
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)