Primary aim of this study is to assess changes in body composition in patients with a carcinoma in the larynx, pharynx or oral cavity, in the period during and after treatment.Secundary aims of this study are:- to assess predictive factors for…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measurement is changes in body composition (fat mass and lean
body mass), assessed by:
- DEXA (dual energy x-ray absorptiometry).
- anthropometerics: skinfold measurements (triceps, biceps, subscapula,
supra-iliaca), upper arm (muscle) circumference
- hand grip strength
- bio-electrical impedance analysis (BIA)
Secondary outcome
Secondary outcome measurements are:
- serum levels leptin, adiponectin, FT3, FT4, TSH, IGF-1, IGF-BP3, albumin,
prealbumin, transferrin, total cholesterol, CRP, IL-1, IL-6, TNF-α and
hemoglobine
- presence of symptoms/complaints
- performance score
Background summary
Patients with a tumor in the upper airway and digestive tract are at high risk
for malnutrition. It is not clear which body compartments are affected in the
period during and after treatment. Until now, prediction of malnutrition is not
possible. As a result of that, it is not possible to evaluate in which patients
prophylactic placement of a PEG tube is indicated or not.
Study objective
Primary aim of this study is to assess changes in body composition in patients
with a carcinoma in the larynx, pharynx or oral cavity, in the period during
and after treatment.
Secundary aims of this study are:
- to assess predictive factors for malnutrition or changes in body composition,
for example biomarkers, TNM classification, tumor localization, irradiation
field, presence of malnutrition before treatment, performance score and
complaints/symptoms
- to assess to which extent the results of body composition measurements are
related to each other.
Study design
In the period during and after treatment, body composition of the patients will
be assessed by DEXA, bioelectrical impedance analysis, anthropometric
measurements and hand grip strength. Furthermore, blood samples will be taken
from the patients three times and nitrogen balance will be assessed, to
investigate if (changes) in biomarkers and presence of catabolism are related
to changes in body composition during and after treatment. Risk factors like
symptoms and complaints and performance score are assessed to analyse if they
are related to malnutrition.
Study burden and risks
No significant health risks are expected from participation in this study.
Radiation exposure induced by DEXA is very low (0.002 - 0.005 mSv) and is lower
than the permitted dose of 5 mVs per year.
The extra burden for the participant consists of:
- 3 times blood collection of 15 ml = 45 ml during the entire investigation.
Measurement of FT3, FT4, TSH, albumin, prealbumin, transferrin, total
cholesterol and CRP are part of routine measurements.
- 3 times DEXA
- 5 to 6 anthropometric measurements , frequency depends on type of treatment:
body weight, upper arm (muscle) circumference, 4 skinfold measurements
- 5 to 6 times hand grip strength
- 3 times BIA
- 3 times dietary history
Postbus 30001
9700 RB
Nederland
Postbus 30001
9700 RB
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14839.042.07 |