Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders (HED)

May 1, 2026 updated by: Christoph Grimm

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.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients (>18 years) with histologically confirmed gynaecological malignancy
  • Planned chemotherapy
  • Written informed consent
  • Expected patient compliance

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HED arm
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.
Dietary supplement: homoeriodictyol sodium
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
Blood samples to evaluate serum zinc concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
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).
Blood samples to evaluate serum platinum concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
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.
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.
24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Grimm

Collaborators

University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

January 11, 2023

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1185/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocl

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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