Effect of Chewing Gum in Hemodialysis Patients

• ClinicalTrials.gov Identifier: NCT04142216
• Recruitment Status: Completed
• First Posted: October 29, 2019
• Results First Posted: May 21, 2020
• Last Update Posted: May 21, 2020
• Sponsor: Istanbul Demiroglu Bilim University
• Information provided by (Responsible Party): Nurten Ozen, Istanbul Demiroglu Bilim University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chewing Gum; Hemodialysis	Dietary Supplement: Chewing Gum	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
• Actual Study Start Date: October 14, 2019
• Actual Primary Completion Date: January 10, 2020
• Actual Study Completion Date: January 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chewing gum group; The patients will be asked to chew on a regular chewing gum for three months.	Dietary Supplement: Chewing Gum; The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months.
No Intervention: Control group; The patients will not chewing gum during three months.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline Intradialytic Weight Gain [ Time Frame: up to 12 weeks ]
   Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
2. Change From Baseline Feeling of Thirst at Three Months [ Time Frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed three times at the end of the dialysis session with Visual Analogue. Thirst intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Thirst increases as the score increases. The high point describes bad outcome.
3. Change From Baseline Dry Mouth at Three Months [ Time Frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed three times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no dry mouth) to 10 (worst dry mouth). Dry mouth increases the score increases. The high point describes bad outcome.
4. Change From Baseline Dry Mouth at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed two times at the end of the dialysis session with sample of saliva. Saliva flow rate/minute will be measured. Saliva flow rate/minute is presented with "ml".
5. Change From Baseline Intradialytic Symptoms at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed with "Dialysis Symptom Index". Using this scoring system, the minimum possible total severity score was 0 if none of the 30 symptoms was present and the maximum potential. Score was 150 if all of the 30 symptoms were reported and rated as "very much bothersome". The minimum value is "0" and the maximum value is "150".

Secondary Outcome Measures :

1. Change From Baseline Anxiety at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.
2. Change From Baseline Fluid Control at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed with "Fluid Control Scale in Hemodialysis Patients". the scale had 24 items and three subdimensions,namely, knowledge, behavior, and attitude. The lowest score obtained from the scale was 24 and the highest score was 72, and the higher the score, the greater the compliance of the patients with fluid control.
3. Change From Baseline Depression at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
   It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Demiroglu Bilim University

Istanbul, Turkey

Sponsors and Collaborators

Istanbul Demiroglu Bilim University

Investigators

• Principal Investigator: Nurten Ozen, Asst. Prof; Istanbul Demiroglu Bilim University

  Study Documents (Full-Text)

Documents provided by Nurten Ozen, Istanbul Demiroglu Bilim University:

Study Protocol and Statistical Analysis Plan  [PDF] April 20, 2020

More Information

Publications:

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.

Cabrera C, Brunelli SM, Rosenbaum D, Anum E, Ramakrishnan K, Jensen DE, Stålhammar NO, Stefánsson 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.

Duruk N, Eşer 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.

Jagodzińska 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.

• Responsible Party: Nurten Ozen, Assistant Professor, Istanbul Demiroglu Bilim University
• ClinicalTrials.gov Identifier: NCT04142216
• Other Study ID Numbers: 2019/7
• First Posted: October 29, 2019
• Results First Posted: May 21, 2020
• Last Update Posted: May 21, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nurten Ozen, Istanbul Demiroglu Bilim University:

Thirst; Weight gain

Additional relevant MeSH terms:

Weight Gain; Body Weight Changes; Body Weight