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出境医 / 临床实验 / Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia (TATA)

Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia (TATA)

Study Description
Brief Summary:
Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).

Condition or disease Intervention/treatment
Sarcopenic Obesity Other: Vegetarian Diet

Detailed Description:
Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Vegetarian Diet
Includes children following a vegetarian diet.
 Other: Vegetarian Diet
Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.
Non-Vegetarian Diet
Includes children following a non-vegetarian diet.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Sarcopenic Obesity [ Time Frame: 6 months ]
    Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.


Secondary Outcome Measures :
  1. Association of a Vegetarian Diet and Sarcopenic Obesity [ Time Frame: 6 months ]
    Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fifty (50) eligible children aged 5 - 15 years old will be recruited at Tata Memorial Hospital in Mumbai, India. Any children with deteriorating health or not being able to perform diet and exercise routines are ineligible. Children getting therapy outside Tata are not eligible.
Criteria

Inclusion Criteria:

  • Newly diagnosed with ALL
  • Able to consume ≥ 80% of dietary requirements enterally
  • Adequate performance status (Lansky score ≥70)
  • Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).

Exclusion Criteria:

  • Refusal of consent
  • Relapsed ALL
  • Down's syndrome; (Other congenital anomalies too)
  • Therapy initiated elsewhere
Contacts and Locations

Contacts
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Contact: Aryal Suvekshya 646-317-2070 sa3234@cumc.columbia.edu

Locations
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India
Tata Memorial Hospital Recruiting
Mumbai, India
Contact: Maya Prasad, MD       maya.prasad@gmail.com   
Contact: Riya Ghosh       riyaghosh028@gmail.com   
Principal Investigator: Maya Prasad, MD         
Sponsors and Collaborators
Columbia University
Tata Memorial Hospital
Investigators
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Principal Investigator: Elena J. Ladas, PhD, RD Columbia University
Tracking Information
First Submitted Date June 3, 2019
First Posted Date June 5, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date April 18, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019) 		Incidence of Sarcopenic Obesity [ Time Frame: 6 months ]
Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2019) 		Association of a Vegetarian Diet and Sarcopenic Obesity [ Time Frame: 6 months ]
Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia
Official Title Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study
Brief Summary Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).
Detailed Description Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Fifty (50) eligible children aged 5 - 15 years old will be recruited at Tata Memorial Hospital in Mumbai, India. Any children with deteriorating health or not being able to perform diet and exercise routines are ineligible. Children getting therapy outside Tata are not eligible.
Condition Sarcopenic Obesity
Intervention Other: Vegetarian Diet
Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.
Study Groups/Cohorts
  • Vegetarian Diet
    Includes children following a vegetarian diet.
    Intervention: Other: Vegetarian Diet
  • Non-Vegetarian Diet
    Includes children following a non-vegetarian diet.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 3, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed with ALL
  • Able to consume ≥ 80% of dietary requirements enterally
  • Adequate performance status (Lansky score ≥70)
  • Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).

Exclusion Criteria:

  • Refusal of consent
  • Relapsed ALL
  • Down's syndrome; (Other congenital anomalies too)
  • Therapy initiated elsewhere
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Aryal Suvekshya 646-317-2070 sa3234@cumc.columbia.edu
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03974893
Other Study ID Numbers AAAR8814
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elena Ladas, Columbia University
Study Sponsor Columbia University
Collaborators Tata Memorial Hospital
Investigators
Principal Investigator: Elena J. Ladas, PhD, RD Columbia University
PRS Account Columbia University
Verification Date June 2019

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