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| Name | Class |
|---|---|
| Gabrielle's Angel Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28-35 days from diagnosis |
| Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etan Orgel, MD MS | Children's Hospital Los Angeles | Principal Investigator |
| Steven D Mittelman, MD PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33792627 | Derived | 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. |
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A non-prospective, historical cohort was used as a comparison group for this single-arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obesity Intervention | Diet: 10% caloric deficit, protein >= 20% calories, fat <25% calories, carbohydrate <55% calories, low glycemic load <100/2000 kcal. Activity: 200 minutes/week of aerobic and resistance training Duration 28 days |
| FG001 | Historical Control | Previous, consecutively treated unselected patients with B-ALL without the IDEAL intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Includes enrolled (or from historical control) with imaging information via DXA scan. | Posted | Median | Inter-Quartile Range | percent change in fat mass | Diagnosis and 28-35 days |
|
A maximum of 35 days from enrollment (i.e., Induction phase only)
Adverse event (AE) reporting was targeted and included: nil per os (NPO, 'nothing by mouth') due to toxicity, use of naso-gastrointestinal/nasojejunal (NG/NJ) or parenteral nutrition, any surgeries, any ICU admissions, Grade 3 or 4 hepatic or pancreatic toxicity, presence of osteonecrosis or fracture. Toxicities due to underlying chemotherapy were not attributable to the intervention and were not captured.
AE data was unavailable for the historical cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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Adverse event reporting was not available from the historical cohort for comparison with the IDEAL cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Etan Orgel | Childrens Hospital Los Angeles | 13233612121 | eorgel@chla.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2018 | Aug 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
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| 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. |
|
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. |
| 28 days |
| 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). | 28 days |
| No MRD and no imaging available |
|
| BG001 | Historical Control | Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI Category | BMI category assigned as per Center for Disease Control & Prevention age and sex normalized values for ages <20 years of age (Absolute BMI for age 20 years and older). Lean BMI%ile 10 to 84.9 (BMI 18.5 to <25) Overweight BMI%ile 85-94.9 (BMI 25-29) Obese BMI%ile >=95 (BMI >=30) | Count of Participants | Participants |
|
| OG001 | Historical Control | Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria. |
|
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| Secondary | 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 | Posted | Count of Participants | Participants | 28-35 days from diagnosis |
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| Secondary | 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. | A total of 392 visits with the PT or RD were expected to be completed as part of the the study intervention. | Posted | Count of Units | Visits | 28 days | Visits | Visits |
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|
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | % adherence | 28 days |
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| 1 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Historical Control | Historical control group Prospective adverse event reporting is NOT available for this group. Zero reflected below therefore reflects the absence of prospective reporting in this arm. | 2 | 80 | 0 | 80 | 0 | 80 |
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| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |