Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders

NCT07573787 | Terminated DMC

• 1 other identifier: 1185/2018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gynecologic Cancers

Keywords

gynecologic cancer; homoeriodictyol; bitter phantogeusia; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Taste tests

  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 Outcomes (4)

• Platinum concentration in saliva samples

  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 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 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

  24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.

Study Arms (1)

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.

Dietary Supplement: homoeriodictyol sodium

Interventions

homoeriodictyol sodium DIETARY_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.

HED arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: patients with gynecologic cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christoph Grimm: lead
• University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. PD MD

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 7, 2026
• Study Start: March 15, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 11, 2023
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AU (1)