Clinical trial NCT04142216: Effect of Chewing Gum in Hemodialysis Patients
Official title: Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chewing Gum
Hemodialysis
Keywords: Thirst
Weight gain
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.

Detailed description: The prevalence of xerostomia varies high in patients with chronic hemodialysis (HD), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. The significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in HD patients is further affected by the restriction in fluid intake. The use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. Thirst is common in chronic HD patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. The osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. Volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the HD session. Increased interdialytic weight in HD patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. Interdialytic weight gain (IWG) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* 18 years of age younger
* Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis.
* The patient who took chemotherapy and radiotherapy
* Have salivary gland infection and dementia
* Oral and / or dental diseases to prevent chewing gum
* Unwilling to to participate to the study

Primary outcomes:
measure: Change From Baseline Intradialytic Weight Gain
timeFrame: up to 12 weeks
measure: Change From Baseline Feeling of Thirst at Three Months
timeFrame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
measure: Change From Baseline Dry Mouth at Three Months
timeFrame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
measure: Change From Baseline Dry Mouth at Three Months
timeFrame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
measure: Change From Baseline Intradialytic Symptoms at Three Months
timeFrame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Secondary outcomes:
measure: Change From Baseline Anxiety at Three Months
timeFrame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
measure: Change From Baseline Fluid Control at Three Months
timeFrame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
measure: Change From Baseline Depression at Three Months
timeFrame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
affiliation: Istanbul Demiroglu Bilim University
name: Nurten Ozen, Asst. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.
citation: Cabrera C, Brunelli SM, Rosenbaum D, Anum E, Ramakrishnan K, Jensen DE, Stalhammar NO, Stefansson BV. A retrospective, longitudinal study estimating the association between interdialytic weight gain and cardiovascular events and death in hemodialysis patients. BMC Nephrol. 2015 Jul 22;16:113. doi: 10.1186/s12882-015-0110-9.
citation: Duruk N, Eser I. The Null Effect of Chewing Gum During Hemodialysis on Dry Mouth. Clin Nurse Spec. 2016 Sep-Oct;30(5):E12-23. doi: 10.1097/NUR.0000000000000234.
citation: Jagodzinska M, Zimmer-Nowicka J, Nowicki M. Three months of regular gum chewing neither alleviates xerostomia nor reduces overhydration in chronic hemodialysis patients. J Ren Nutr. 2011 Sep;21(5):410-7. doi: 10.1053/j.jrn.2010.08.002. Epub 2010 Dec 24.