CachexiaNCT02798003
Food Reward in Cachexia Induced by Acute or Chronic Disease
An observational study of Cachexia and Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Chronic Obstructive Pulmonary Disease, Non-small Cell Lung Cancer
- What is being tested?
- Functional magnetic resonance imaging (fMRI)
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2016to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four groups will be included: 1. Cachectic cancer patients, including NSCLC and gastro-intestinal cancer 2. Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer 3. Cachectic COPD patients 4. Non-cachectic COPD patients Individuals of all groups will be gender and age matched. In addition, COPD patients will be matched for FEV1.
Who may be able to join
- For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or >2% when body mass index is <20 kg/m2
- For non-cachectic patients: no weight loss of ≥5% during the last 6 months
- Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
Who cannot join
- Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up)
- Psychiatric or other disorders likely to impact on informed consent
- Presence of brain metastasis (screening is not mandatory)
- Medical history of cerebrovascular accident, brain tumour, brain metastasis
- Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy
- Memory problems
Show all 15Show fewer
- Current use of tube feeding or parental nutrition
- Patients with an active second malignancy
- Patients unable to lie still for 2 hours
- Unable to complete the cognitive task
- Pre-existing swallowing difficulties
- Allergy to gluten-, milk- or wheat products
- Self-reported hyperthyroidism
- Self-reported diabetes mellitus
- Current use of appetite stimulant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease
To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.
Read the detailed description
The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.
- Conditions
- Cachexia, Chronic Obstructive Pulmonary Disease, Non-small Cell Lung Cancer, Pancreatic Cancer
- Being tested
- Functional magnetic resonance imaging (fMRI)
- Keywords
- Cachexia, Food reward
- Medical subject headings
- Cachexia, Pulmonary Disease, Chronic Obstructive, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI)Other
The food-cue elicited response in the reward-circuitry of the brain will be assessed by using fMRI. This technique is based on different magnetic properties of oxygenated and deoxygenated blood. Increased neuronal activity causes an increase in blood flow. Thereby, neuronal activity is indirectly reflected by changes in blood oxygenation level-dependent (BOLD) contrast.
| Study group | Role | What they receive |
|---|---|---|
| Cachectic cancer patients | Cachectic cancer patients, including non-small cell lung cancer (NSCLC) and gastro-intestinal cancer. The study participants will undergo fMRI scanning. Receives: Other: Functional magnetic resonance imaging (fMRI) | |
| Non-cachectic cancer patients | Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer. The study participants will undergo Functional magnetic resonance imaging (fMRI) scanning. Receives: Other: Functional magnetic resonance imaging (fMRI) | |
| Cachectic COPD patients | Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning. Receives: Other: Functional magnetic resonance imaging (fMRI) | |
| Non-cachectic COPD patients | Diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning. Receives: Other: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward.
Measured: 2 years
Secondary outcomes (6)
Dietary intake assessed by a food diary
Measured: 2 years
Blood parameters: glucose (mmol/L)
Measured: 2 years
Blood parameters: insulin (pmol/L)
Measured: 2 years
Blood parameters: leptin (ug/L)
Measured: 2 years
Blood parameters: ghrelin (pg/mL)
Measured: 2 years
Blood parameters: glucagon-like peptide-1 (pmol/L)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start1 Dec 2016
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: Not feasible to include the needed patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemie Schols, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798003
- Sponsor's protocol ID
- NL54799.068.15
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2016
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease
- ClinicalTrials.gov ID
- NCT02798003
- Acronym / sponsor ID
- NL54799.068.15
- Conditions
- Cachexia, Chronic Obstructive Pulmonary Disease, Non-small Cell Lung Cancer, Pancreatic Cancer
- Keywords
- Cachexia, Food reward
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not feasible to include the needed patients
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.
Detailed description
The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cachectic cancer patients | – | Other: Functional magnetic resonance imaging (fMRI)Cachectic cancer patients, including non-small cell lung cancer (NSCLC) and gastro-intestinal cancer. The study participants will undergo fMRI scanning. |
| Non-cachectic cancer patients | – | Other: Functional magnetic resonance imaging (fMRI)Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer. The study participants will undergo Functional magnetic resonance imaging (fMRI) scanning. |
| Cachectic COPD patients | – | Other: Functional magnetic resonance imaging (fMRI)Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning. |
| Non-cachectic COPD patients | – | Other: Functional magnetic resonance imaging (fMRI)Diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four groups will be included: 1. Cachectic cancer patients, including NSCLC and gastro-intestinal cancer 2. Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer 3. Cachectic COPD patients 4. Non-cachectic COPD patients Individuals of all groups will be gender and age matched. In addition, COPD patients will be matched for FEV1.
Key inclusion criteria (3 listed)
- For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or >2% when body mass index is <20 kg/m2
- For non-cachectic patients: no weight loss of ≥5% during the last 6 months
- Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
Key exclusion criteria (15 listed)
- Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up)
- Psychiatric or other disorders likely to impact on informed consent
- Presence of brain metastasis (screening is not mandatory)
- Medical history of cerebrovascular accident, brain tumour, brain metastasis
- Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging (fMRI)The food-cue elicited response in the reward-circuitry of the brain will be assessed by using fMRI. This technique is based on different magnetic properties of oxygenated and deoxygenated blood. Increased neuronal activity causes an increase in blood flow. Thereby, neuronal activity is indirectly reflected by changes in blood oxygenation level-dependent (BOLD) contrast. | Other | Cachectic COPD patients, Cachectic cancer patients, Non-cachectic COPD patients, Non-cachectic cancer patients |
Primary outcome
Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward.
Time frame: 2 years
6 secondary outcomes
Dietary intake assessed by a food diary
Time frame: 2 years
Blood parameters: glucose (mmol/L)
Time frame: 2 years
Blood parameters: insulin (pmol/L)
Time frame: 2 years
Blood parameters: leptin (ug/L)
Time frame: 2 years
Blood parameters: ghrelin (pg/mL)
Time frame: 2 years
Blood parameters: glucagon-like peptide-1 (pmol/L)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Not feasible to include the needed patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Schols, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia and Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not feasible to include the needed patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.