Analysis of food reward system and taste perception in cachexia induced by acute or chronic disease

Completed

• Conditions: Cachexia; Anorexia; 10003018; 10027656; 10029107

• Registration Number: NL-OMON47837
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-18
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Head and Neck Cancer (HNC) patients treated with concurrent chemoradiation or bioradiation with curative intent.
-Treatment completion 2-3 months ago
-70>= age >=18;Healthy controls
-Matched for age, gender, smoking behaviour, and scanning hour of the day.

Exclusion Criteria

For all groups:
- 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)
- Pregnancy
- 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
- 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 in the imitation scanner
- Allergy to gluten-, milk- or wheat products
- Self-reported hyperthyroidism
- Current use of appetite stimulant medications
- Recurrent head and neck cancer (rHNC)
- Previously administered systemic anti-tumor therapy
- Reirradiation setting
- Analphabetic
- Mini mental state examination score <21
- Concurrent neurological disease (e.g. morbus Parkinson)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is neural representations of taste stimuli. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the relation between brain reward-related activity,<br /><br>anorexia based on a dietary questionnaire and in LAHNSCC patients only, the<br /><br>relation between taste perception and food reward related activity and degree<br /><br>of recovery after chemoradiation (CRT). </p><br>