Objective: This study objectifies the incidence and quantifies the degree of malabsorption in patients with high dose chemotherapy- or GVHD-induced-mucositis by 2 different valid markers (fecal analyses NIRs and CGT).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hematologische aandoeningen waarvoor behandeld wordt met een autologe of allogene stamceltransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of this study is the incidence of malabsorption and the level
of severity of malabsorption in patients with hematological malignancies with
chemotherapy- or GVHD-induced-mucositis by standard fecal analysis in
combination with dietary (oral/enteral) intake of energy and macronutrients (as
percentage intestinal absorption capacity).
Secondary outcome
Secondary endpoints are the accuracy and applicability of fecal volume and
citrulline (generation) test (CGT) as markers for malabsorption compared
standard procedures (fecal analyses in combination with dietary intake) in
these patients.
Background summary
Malnutrition occurs in up to 45% of patients with hematological malignancies
undergoing allogeneic stem cell transplantation (aSCT) and is negatively
associated with clinical outcome, mainly with poor overall survival, increased
transplant-related mortality and higher relapse rate. Contrary to other
prognostic factors such as age, malnutrition can possibly be influenced by
timely dietary intervention, by oral, enteral or parenteral administration.
Gastro-intestinal mucositis as a result of chemotherapy or graft versus host
disease of the digestive tract (GVHD), are common side effects, which can lead
to severe diarrhea. The severe diarrhea that patients experience can be caused
by a (partial) failure of the gastrointestinal tract and, in addition to loss
of electrolytes and fluid, might be accompanied by loss of nutrients due to an
impaired nutrient absorption (=malabsorption). In clinical practice,
malabsorption can be objectified and quantified by the intensive method of
combining accurate data of oral/enteral food intake (96 hours) and quantifying
fecal losses (48-72 hours; volume, energy, fat and nitrogen by gold standard
manual techniques as well as recently available *quick and easy* near infrared
spectroscopy (NIRs)). Besides, serum citrulline and the citrulline generation
test (CGT) are intestinal function markers, however these methods are as yet
not validated in patients with hematological malignancies.
Study objective
Objective: This study objectifies the incidence and quantifies the degree of
malabsorption in patients with high dose chemotherapy- or
GVHD-induced-mucositis by 2 different valid markers (fecal analyses NIRs and
CGT).
Study design
Observational, prospective study performed at the inpatient Dept of Hematology
of Amsterdam UMC. The expected duration of inclusion for this study is one
year.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: During hospital admission data will be collected
from electronic patients files already taken for regular patientcare. Patients
do not need to visit the hospital for an extra measurement. Fecal collection
(48-72 hour) and 72-hour nutritional diary are extra procedures, but former
research has shown that it is feasible in patients with hematological
malignancies. For CGT, 3 venous blood sample (100 uL) are conducted (fasting,
75 and 90 min after Dipeptiven* administration), purchased through PICC line,
which is already placed for hematological treatment. Therefore no added risk
are expected.
The risks in participating in this study are negligible. All study procedures
included in this study are part of standard clinical care. Although these tests
are not often applied to diagnose malabsorption in patients with hematological
malignancies, in clinical practice these tests are widely used, without any
associated risks.
The benefit of participating in this study is that patients will undergo
diagnostic tests to objectively determine the presence of malabsorption. As
soon as malabsorption is detected in our study population, dietary policy can
be adjusted accordingly.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Clinical admitted adult patients with hematological malignancies
- Suffer from chemotherapy- or GVHD-induced-mucositis with diarrhea
Exclusion criteria
- Unable to speak, read or write Dutch or English language
- Pregnant or lactating women
- Weight <40 kg
- Comorbidities in which malabsorption can be expected (ao celiac disease, IBD,
short bowel syndrome, exocrine pancreatic insufficiency)
- Altered anatomy of the gastrointestinal tract (ao intestinal segment
resections, stomata)
- Severe renal impairment (kreatinine clearance < 25 ml/minute), severe hepatic
impairment, severe metabolic acidosis or hypersensitivity to the active
substance or to N(2)-L-alanyl-L-glutamine.
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 | NL73473.029.20 |