Gynecologic CancersHEDNCT07573787
Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders
A study testing homoeriodictyol sodium in people with Gynecologic Cancers, run by Christoph Grimm at 1 site in Austria.
Trial summary
Background: More than 75% of women with cancer experience taste disorders during adjuvant chemotherapy. Bitter phantogeusia is particularly limiting. This can lead to impaired food intake with reduced energy intake, as well as changes in body composition, a reduced quality of life, and weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers
- What is being tested?
- homoeriodictyol sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 15 Mar 2021to 11 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (>18 years) with histologically confirmed gynaecological malignancy
- Planned chemotherapy
- Written informed consent
- Expected patient compliance
Who cannot join
- Vomiting (CTCAE 4.03) > Grade 2 (3-5 episodes within 24 hours)
- Nasogastric tube or PEG tube
- Previous platinum-based chemotherapy
- Conditions that impair taste perception (e.g., infections in the oral cavity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders - a Pilot Study
Background: More than 75% of women with cancer experience taste disorders during adjuvant chemotherapy. Bitter phantogeusia is particularly limiting. This can lead to impaired food intake with reduced energy intake, as well as changes in body composition, a reduced quality of life, and weight loss.
Study Objective: The objective of this pilot phase of the study is, on one hand, to evaluate taste testing during chemotherapy and, on the other hand, to significantly reduce bitter phantogeusia by using a mouthwash containing homoeriodictyol (HED) immediately before consuming main meals. Taste testing during chemotherapy will be evaluated as part of a pilot study.
Read more
Methods: As part of a pilot study, taste sensitivity is assessed before the start of chemotherapy and during chemotherapy. This phase of the study includes 40 patients undergoing chemotherapy. Taste sensitivity assessments are conducted before the start of chemotherapy and during the third cycle of chemotherapy, and blood samples are also collected. Food intake is assessed once a week using a 24-hour recall, and saliva samples are collected during the third cycle of chemotherapy.
Conclusion: Aim of this study is to evaluate changes in taste perception during chemotherapy and to demonstrate a reduction in bitter phantogeusia following the use of a HED mouthwash in women with cancer undergoing chemotherapy.
At a later stage, a controlled study is planned. In the double-blind, randomized, placebo-controlled study, patients with bitter phantogeusia during chemotherapy will be included. The primary endpoint will be the measured reduction in the perception of bitterness from 500 ppm caffeine between week 1 and week 3. This is intended to improve food intake and body composition and counteract treatment-related weight loss.
- Conditions
- Gynecologic Cancers
- Being tested
- homoeriodictyol sodium
- Keywords
- gynecologic cancer, homoeriodictyol, bitter phantogeusia, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homoeriodictyol sodiumDietary supplement
To prepare the study medication, 30 mg of homoeriodictyol sodium is granulated with food coloring, an opacifier and a carrier material (manufactured by Symrise AG, Holzminden, Germany) and then packaged in airtight bags. The powder is portioned and packed into bags at the Institute of Physiological Chemistry using portioning spoons.
| Study group | Role | What they receive |
|---|---|---|
| HED arm | Experimental | In the clinical pilot study, taste sensitivity was assessed by measuring detection and recognition thresholds for sweet, bitter, and metallic tastes using standardized sensory tests in the same patients, first when chemo-naïve and again 6 - 7 weeks after initiation of carboplatin-based chemotherapy, to evaluate chemotherapy-induced changes. In addition, subjective changes in taste perception were evaluated using a questionnaire. Patients, who were able to perceive and assess the bitterness of caffeine solutions, were included in the analysis of the effect of the Na-HED rinse-and-spit solution. Receives: Dietary Supplement: homoeriodictyol sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste tests
Taste tests will be conducted before the start of chemotherapy and during the third cycle of chemotherapy.
Measured: Taste tests will be conducted before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Secondary outcomes (4)
Platinum concentration in saliva samples
Saliva samples will be collected directly before the start of chemotherapy and 1 hour, 6 hours, 18 hours and 24 hours after start of chemotherapy. This will be performed during first and third cycle of chemotherapy.
Measured: Saliva samples will be collected before chemotherapy and 2, 4, 6, and 18-20 hours after start of chemotherapy. These samples will be assessed at the day of first and third cycle of chemotherapy (each cycle is 21 days, thus assessment).
Serum zinc concentration
Blood samples to evaluate serum zinc concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
Measured: Blood samples will be assessed before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Serum platinum concentration
Blood samples to evaluate serum platinum concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
Measured: Blood samples will be assessed before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Food intake measurements
Food intake will be assessed using a 24-hour recall before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.
Measured: 24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start15 Mar 2021
- Primary completion10 Jan 2023
- Study completion11 Jan 2023
Why it stopped: slow recruitment during COVID pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Grimm
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Sponsor-investigator, Christoph Grimm, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573787
- Sponsor's protocol ID
- 1185/2018
- Acronym
- HED
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocl
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders - a Pilot Study
- ClinicalTrials.gov ID
- NCT07573787
- Acronym / sponsor ID
- HED / 1185/2018
- Conditions
- Gynecologic Cancers
- Keywords
- gynecologic cancer, homoeriodictyol, bitter phantogeusia, chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment during COVID pandemia
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Christoph GrimmUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: More than 75% of women with cancer experience taste disorders during adjuvant chemotherapy. Bitter phantogeusia is particularly limiting. This can lead to impaired food intake with reduced energy intake, as well as changes in body composition, a reduced quality of life, and weight loss.
Study Objective: The objective of this pilot phase of the study is, on one hand, to evaluate taste testing during chemotherapy and, on the other hand, to significantly reduce bitter phantogeusia by using a mouthwash containing homoeriodictyol (HED) immediately before consuming main meals. Taste testing during chemotherapy will be evaluated as part of a pilot study.
Methods: As part of a pilot study, taste sensitivity is assessed before the start of chemotherapy and during chemotherapy. This phase of the study includes 40 patients undergoing chemotherapy. Taste sensitivity assessments are conducted before the start of chemotherapy and during the third cycle of chemotherapy, and blood samples are also collected. Food intake is assessed once a week using a 24-hour recall, and saliva samples are collected during the third cycle of chemotherapy.
Conclusion: Aim of this study is to evaluate changes in taste perception during chemotherapy and to demonstrate a reduction in bitter phantogeusia following the use of a HED mouthwash in women with cancer undergoing chemotherapy.
At a later stage, a controlled study is planned. In the double-blind, randomized, placebo-controlled study, patients with bitter phantogeusia during chemotherapy will be included. The primary endpoint will be the measured reduction in the perception of bitterness from 500 ppm caffeine between week 1 and week 3. This is intended to improve food intake and body composition and counteract treatment-related weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HED arm | Experimental | Dietary Supplement: homoeriodictyol sodiumIn the clinical pilot study, taste sensitivity was assessed by measuring detection and recognition thresholds for sweet, bitter, and metallic tastes using standardized sensory tests in the same patients, first when chemo-naïve and again 6 - 7 weeks after initiation of carboplatin-based chemotherapy, to evaluate chemotherapy-induced changes. In addition, subjective changes in taste perception were evaluated using a questionnaire. Patients, who were able to perceive and assess the bitterness of caffeine solutions, were included in the analysis of the effect of the Na-HED rinse-and-spit solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients (>18 years) with histologically confirmed gynaecological malignancy
- Planned chemotherapy
- Written informed consent
- Expected patient compliance
Key exclusion criteria (4 listed)
- Vomiting (CTCAE 4.03) > Grade 2 (3-5 episodes within 24 hours)
- Nasogastric tube or PEG tube
- Previous platinum-based chemotherapy
- Conditions that impair taste perception (e.g., infections in the oral cavity)
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 |
|---|---|---|
| homoeriodictyol sodiumTo prepare the study medication, 30 mg of homoeriodictyol sodium is granulated with food coloring, an opacifier and a carrier material (manufactured by Symrise AG, Holzminden, Germany) and then packaged in airtight bags. The powder is portioned and packed into bags at the Institute of Physiological Chemistry using portioning spoons. | Dietary supplement | HED arm |
Primary outcome
Taste tests
Time frame: Taste tests will be conducted before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Taste tests will be conducted before the start of chemotherapy and during the third cycle of chemotherapy.
4 secondary outcomes
Platinum concentration in saliva samples
Time frame: Saliva samples will be collected before chemotherapy and 2, 4, 6, and 18-20 hours after start of chemotherapy. These samples will be assessed at the day of first and third cycle of chemotherapy (each cycle is 21 days, thus assessment).
Serum zinc concentration
Time frame: Blood samples will be assessed before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Serum platinum concentration
Time frame: Blood samples will be assessed before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).
Food intake measurements
Time frame: 24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.
Results and safety
The study was stopped early (reason given: slow recruitment during COVID pandemia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. study protocl
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing homoeriodictyol sodium in people with Gynecologic Cancers, run by Christoph Grimm at 1 site in Austria.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 May 2026. 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 Austria. 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?
The study was stopped early (reason given: slow recruitment during COVID pandemia). Results are not available in the source record.
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?
Taste tests (time frame: Taste tests will be conducted before the start of chemotherapy and at the third cycle of chemotherapy (each cycle is 21 days, thus assessment is performed at day 42).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.