Chewing GumNCT04142216
Effect of Chewing Gum in Hemodialysis Patients
A study testing Chewing Gum in people with Chewing Gum and Hemodialysis, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chewing Gum, Hemodialysis
- What is being tested?
- Chewing Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chewing Gum, Hemodialysis
- Being tested
- Chewing Gum
- Keywords
- Thirst, Weight gain
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum group | Experimental | The patients will be asked to chew on a regular chewing gum for three months. Receives: Dietary Supplement: Chewing Gum |
| Control group | No intervention | The patients will not chewing gum during three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Intradialytic Weight Gain
Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
Measured: up to 12 weeks
Change From Baseline Feeling of Thirst at Three Months
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.
Measured: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Dry Mouth at Three Months
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.
Measured: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Dry Mouth at Three Months
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".
Measured: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Intradialytic Symptoms at Three Months
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".
Measured: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Secondary outcomes (3)
Change From Baseline Anxiety at Three Months
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.
Measured: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Fluid Control at Three Months
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.
Measured: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Depression at Three Months
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.
Measured: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start14 Oct 2019
- Primary completion10 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chewing GumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul Demiroglu Bilim University
- Investigators
- Nurten Ozen, Asst. Prof, Principal investigator, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142216
- Sponsor's protocol ID
- 2019/7
- Status last verified
- May 2020
- First submitted
- 24 Oct 2019
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1111/j.1523-1755.2004.00933.x.
PubMed 15458464Cabrera 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.
PubMed 26197758Duruk 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.
PubMed 27509571Jagodzinska 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.
PubMed 21185739
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04142216
- Acronym / sponsor ID
- 2019/7
- Conditions
- Chewing Gum, Hemodialysis
- Keywords
- Thirst, Weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum group | Experimental | Dietary Supplement: Chewing GumThe patients will be asked to chew on a regular chewing gum for three months. |
| Control group | No intervention | –The patients will not chewing gum during three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing GumThe patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months. | Dietary supplement | Chewing gum group |
Primary outcome
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
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.
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.
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".
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".
3 secondary outcomes
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15458464Bots 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.
- Background: PubMed 26197758Cabrera 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.
- Background: PubMed 27509571Duruk 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.
- Background: PubMed 21185739Jagodzinska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurten Ozen, Asst. Prof principal investigator
Istanbul Demiroglu Bilim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing Gum in people with Chewing Gum and Hemodialysis, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Intradialytic Weight Gain (time frame: up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142216, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.