跳至主要内容
临床试验/NCT07573787
NCT07573787终止不适用

Homoeriodictyol Sodium Mouthwash to Reduce Chemotherapy Induced Bitter Taste Disorders - a Pilot Study

Christoph Grimm1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3月15日最近更新:

试验速览

阶段
不适用
状态
终止
发起方
入组人数
15
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究者

发起方
Christoph Grimm
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christoph Grimm

Assoc. Prof. PD MD

Medical University of Vienna

研究点 (1)

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