Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02500004
Other study ID # 142071
Secondary ID NL51402.068.14
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date July 2018

Study information

Verified date March 2016
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.


Description:

This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria:

- Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients

- The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index < 20 kg/m2 and muscle wasting assessed by DXA;

- Age = 30 years;

- Gender: male and female;

- Caucasians.

Exclusion Criteria:

- Uncontrolled Diabetes Mellitus;

- Patients with severe clotting disorder;

- Patients with an active second malignancy;

- Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia;

- Persons unable to lie or sit still for 1-2 hours;

- Oxygen therapy;

- Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets);

- Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history;

- Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;

- The use of medication that influences the sympathetic nerve system: ß-blockers, a-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
18F-FDG PET-MRI-imaging
BAT activity: 18F-FDG PET-MRI-imaging.
DXA scanning
Body composition: DXA scanning, D2O and MRI.
Procedure:
Abdominal subcutaneous adipose tissue biopsy
Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.
Blood sampling
Systemic inflammatory profile: blood sampling.
Other:
Indirect calorimetry
Resting metabolic rate: indirect calorimetry.
Device:
Accelerometry
Physical activity level: accelerometry.
Other:
Double-labeled water
Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.

Locations

Country Name City State
Netherlands Maastricht UMC+ Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brown adipose tissue (BAT) activity measured by PET(-MRI) The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning. participants will be followed for 2 weeks
Secondary Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water participants will be followed for 2 weeks
Secondary Resting metabolic rate measured by REE participants will be followed for 2 weeks
Secondary Metabolic gene expression in WAT measured by biopsy of subcutaneous fat participants will be followed for 2 weeks
Secondary Systemic inflammatory status measured in blood participants will be followed for 2 weeks
Secondary Fat tissue mass measured by MRI, DXA, and doubly labeled water Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA) participants will be followed for 2 weeks
Secondary Hormonal status measured in blood participants will be followed for 2 weeks
Secondary Lean tissue mass measured by MRI, DXA, and doubly labeled water Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA) participants will be followed for 2 weeks
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A