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Body Composition and Physical Function Assessment for Childhood Cancer
N/A
Recruiting
Led By Jessica Benjamin-Eze
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will study how cancer treatments affect muscle mass, physical ability, and aging in children.
Who is the study for?
This trial is for children aged 8-21 with newly diagnosed malignant solid tumors or lymphoma, who are undergoing cancer treatment and can consent in English or Spanish. They must be approved by their treating physician to participate and able to undergo routine imaging like CT, MRI, or PET scans. It's not for those with a history of cancer treated only by surgery, planning palliative care, opting out of chemo/radiotherapy, diagnosed with leukemia, unable to consent, speaking other languages than English/Spanish or having conditions that prevent BIA assessment.Check my eligibility
What is being tested?
The study measures lean muscle mass changes using Bioelectrical Impedance Analysis (BIA), D3-Creatine Dilution (D3Cr) method; physical function through tests like the 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), Sit-to-Stand test; grip strength; biological aging via PBTL p16 expression; alongside routine imaging during active cancer therapy.See study design
What are the potential side effects?
Since this trial involves non-invasive measurements and standard imaging procedures rather than testing new drugs or treatments directly on participants' bodies, there are minimal side effects expected from the interventions themselves.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The feasibility of collecting body composition assessments
The feasibility of collecting individual physical function assessments
Secondary outcome measures
Feasibility of collecting repeated measurements of biological aging (p16 expression)
The acceptability of the study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment8 Interventions
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,303 Total Patients Enrolled
Jessica Benjamin-EzePrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been recently diagnosed with cancer in either my solid organs or lymph nodes.I have had cancer before.I have only had surgery to remove my condition.I am scheduled for treatment to relieve symptoms.I have chosen not to undergo chemotherapy or radiotherapy.I was diagnosed with cancer between the ages of 8 and 21.I have been diagnosed with leukemia.I am expected to undergo treatment such as chemotherapy, radiation, or immunotherapy for my cancer.I speak English or Spanish.My current cancer doctor has approved my participation in this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this clinical trial extending beyond fifty years of age?
"To participate in this clinical trial, volunteers must be between 8 and 21 years of age."
Answered by AI
What criteria are necessary for an individual to be eligible for this trial?
"This clinical trial will include 30 individuals between 8 and 21 years old diagnosed with cancer. To be eligible, they must also comply with the following additional criteria: ages 8-21 at diagnosis of malignancy and planned treatment including chemotherapy, radiation therapy, immunotherapy or other innovative biologic therapies."
Answered by AI
Is there an open enrollment period for this particular research study?
"Judging from the information available on clinicaltrials.gov, this medical investigation is presently recruiting patients. It was initially posted on May 1st 2023 and recently revised on May 15th 2023."
Answered by AI
How many individuals are being administered treatment in this research program?
"Affirmative. Clinicaltrials.gov data indicates that this research trial, initially posted on May 1st 2023 is currently recruiting candidates for participation. The study seeks to enroll 30 patients at a single location."
Answered by AI
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