Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Diabetes Mellitus

Kidney Diseases

Metabolic Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Male and female volunteers aged 10+ years in good general health as evidenced by medical history

Male and female patients aged 10+ years diagnosed with diseases thought to alter metabolism or body composition and/or taking medication thought to alter metabolism or body composition

Margaret S McGehee, C.R.N.P.

Kong Y Chen, Ph.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.

Objective:

This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.

Eligibility:

Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.

Design:

Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.

Participants will undergo many tests:

They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.

They will lie on a padded table for about 15 minutes while their body is scanned.

They will stand on a platform while a 3D scanner measures their body.

They will have a test to measure how fast an electric signal moves through their body.

They will grip an instrument to measure the strength of their hands.

They will drink salty water and provide blood and urine samples.

Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.

Study Description:

This study will examine the relationships between comprehensively measured resting energy expenditure (REE), body composition, and body surface area (BSA) in a wide range of healthy and diseased individuals.

Objectives:

Primary Objectives:

* To compare estimated and measured BSA.
* To determine if measured BSA is associated with REE independent of body composition measures

Endpoints:

Primary Endpoints:

* Mean difference and limits of agreement at baseline between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight.
* Increase in R\^2 when measured BSA is added to equations predicting REE.

A Natural History Study of Metabolic Sizing in Health and Disease

Increase in R2 when measured BSA is added to equations predicting REE

Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Neoplasms

Skin and Connective Tissue Diseases

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Body Weight

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Docetaxel

Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol

male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol

Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose

Lean body mass

Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose

Total body weight

Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model

bloodsampling

Rien Hoge, PharmD

Frank Jansman, PharmD, PhD

Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma.

Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment.

The investigators will determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.

Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma.

Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment.

For most anti-cancer drugs, including docetaxel, other anthropometric parameters, such as Lean Body Mass (LBM), have been suggested to be superior to Body Surface Are (BSA) as a determinant for dosing but this has not been implemented in clinical practice.

The investigators will determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.

The investigators will determine if occurrence of docetaxel toxicity can be related to dose/LBM.

The investigators will determine which methods to measure LBM: DEXA, Bioelectrical Impedance Assessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel.

Blood samples for docetaxel concentration measurement (n=4)

Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity

To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females

can docetaxel toxicity be related to dose/LBM? docetaxel toxicity is defined as: number of rates of grade 3/4 toxicity, dose delay, dose reduction, treatment termination and combinations of all four as Dose-Limiting Toxicity (DLT)

To determine which methods to measure LBM: Bioelectrical Impedance As-sessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel. These methods will be compared to the LBM derived from the DEXA scan as the general accepted, accurate and validated method for determining LBM.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Natural History Study of Metabolic Sizing in Health and Disease	NCT05398783	Metabolic Disor... Cancer Chronic Kidney ... Diabetes Normal Physiolo...		2 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity	NCT01621425	Breast Cancer Metastatic Cast...	Lean body mass Total body weig... bloodsampling	18 Years -	Radboud University Medical Center
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity	NCT01621425	Breast Cancer Metastatic Cast...	Lean body mass Total body weig... bloodsampling	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for body surface area