Changes in body composition in patients with cancer in the upper airway and digestive tract: a prospective study
Recruiting
- Conditions
- malnutritionundernutrition1000301810027655
- Registration Number
- NL-OMON34021
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
- malignant tumour in the upper digestive and airway tract: larynx, pharynx or oral cavity
- curative treatment with surgery and postoperative radiotherapy, or radiotherapy, or chemoradiation
- age 18 year or above
- caucasian race
- good understanding of dutch language
Exclusion Criteria
- palliative treatment
- tumor in other region than head and neck region (either secondary primary tumor or metastasis)
- amputated arm(s)/leg(s)
- oedema as a result of cardial failure, ascites, nefrological or hepatic dysfunction
- orthopedic prosthesis (hip or knee)
- pacemaker
- dementia/mental dysfunction
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measurement is changes in body composition (fat mass and lean<br /><br>body mass), assessed by:<br /><br>- DEXA (dual energy x-ray absorptiometry).<br /><br>- anthropometerics: skinfold measurements (triceps, biceps, subscapula,<br /><br>supra-iliaca), upper arm (muscle) circumference<br /><br>- hand grip strength<br /><br>- bio-electrical impedance analysis (BIA) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measurements are:<br /><br>- serum levels leptin, adiponectin, FT3, FT4, TSH, IGF-1, IGF-BP3, albumin,<br /><br>prealbumin, transferrin, total cholesterol, CRP, IL-1, IL-6, TNF-a and<br /><br>hemoglobine<br /><br>- presence of symptoms/complaints<br /><br>- performance score</p><br>