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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Vienna、オーストリア
- Medical University of Vienna
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Taste tests
時間枠：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).
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Taste tests will be conducted before the start of chemotherapy and during the third cycle of chemotherapy.
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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).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Platinum concentration in saliva samples
時間枠：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).
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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.
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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).
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Serum zinc concentration
時間枠：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).
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Blood samples to evaluate serum zinc concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
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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).
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Serum platinum concentration
時間枠：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).
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Blood samples to evaluate serum platinum concentration will be assessed directly before chemotherapy at chemotherapy cycle one and three.
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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).
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Food intake measurements
時間枠：24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.
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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.
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24-hour recall will be performed before the start of chemotherapy, one week, three weeks, and 13 weeks after the start of chemotherapy.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1185/2018
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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