Primary objective: To study the prevalence and nature of taste and smell disturbances in GvHD patients. Secondary objective: To study whether the prevalence and nature of taste and smell disturbances are related to - oral GvHD - salivary flow - oral…
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
smaak-en reukstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Qualitative and quantitative measurements of taste disturbances -
Quantitative measurements of smell disturbances
Secondary outcome
- Amount of (un)stimulated salivary flow - (Oral health related) quality of
life - Score overall GvHD - Oral GvHD (subjective/objective) - Perception of
taste and smell changes
Background summary
Over the past 50 years, more than a million hematopoietic stem cell
transplantations (HSCT) have been performed. The success of allogeneic HSCT is
tempered by one of the most common and potentially life-threatening
complications, graft-versus-host disease (GvHD), an alloimmune response of
donor immune cells against healthy recipient\u2019s tissues including skin,
liver, lungs, gut, oropharynx and oral cavity. Despite improvements in donor
selection, tailored conditioning regimens, and better supportive care, the
incidence of GVHD will increase related to more frequent use of unrelated
donors and the aging of the donor and de recipients. Clinical oral
complications of GvHD manifest from relatively innocent oral lichen planus-like
erythema/ulcers up to severe oral lesions, salivary dysfunction, impaired mouth
opening and taste disturbances. A limited number of studies have focused on
taste alterations among HSCT patients. Alterations in taste perception are
commonly caused by upper respiratory viral infections and infections in the
oral cavity. Furthermore, activation of inflammatory pathways by immune
dysregulation may alter taste bud homeostasis and contribute to the development
of taste disorders. Finally, treatment modalities such as radiotherapy and
chemotherapy can also temporarily or permanently disrupt taste bud homeostasis
through direct damage to the taste cells. Although there is some evidence for
taste changes in allogeneic HSCT recipients, it is not clear what the
prevalence of taste and smell changes is and whether these changes are related
to oral GvHD. Therefore, the aim of this project is to study the prevalence of
taste and smell disturbances in GvHD patients and to study whether there is a
relationship between post-allogeneic HSCT taste and smell disturbances and oral
GvHD.
Study objective
Primary objective: To study the prevalence and nature of taste and smell
disturbances in GvHD patients. Secondary objective: To study whether the
prevalence and nature of taste and smell disturbances are related to - oral
GvHD - salivary flow - oral health related quality of life - subjective
complaints of taste and smell disturbances
Study design
Single center, cross-sectional study that takes place at the departments of
hematology and oral and maxillofacial surgery in the AMC. All patients are
diagnosed with GvHD, we will compare two subgroups: with and without oral GvHD.
The duration of the study will be approximately 1 year.
Study burden and risks
No risk for participants
Meibergdreef 9
Amsterdam 1191GM
NL
Meibergdreef 9
Amsterdam 1191GM
NL
Listed location countries
Age
Inclusion criteria
adult allogeneic hematopoietic stem cell transplantation recipients with graft versus host disease
Exclusion criteria
allogeneic HSCT recipients without GVHD, patients with neurodegenerative diseases and smokers
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 | NL69437.018.19 |