Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders (HED)
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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Vienna, Itävalta
- Medical University of Vienna
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Taste tests
Aikaikkuna: 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).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Platinum concentration in saliva samples
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- 1185/2018
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .