Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures. (FROST)
A Randomized Controlled 2×2 Factorial Study Evaluating Sucrose and Cold for the Treatment of Oral Pruritus During Allergy Procedures
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures.
The population will include patients aged 8 years and older presenting with oral pruritus in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Clinically significant oral pruritus will be defined as a pruritus intensity of ≥3/10 on the ICH NRS, and a symptom bothersome enough that the patient would normally seek treatment.
Eligible participants will be randomized to one of four groups (1:1:1:1 ratio):
- Sucrose only (3.5 g granulated sugar)
- Cold only (20 mL of ice in the form of popsicle)
- Sucrose + cold (20 mL frozen sucrose solution)
- Control (20 mL room-temperature water)
Participants will be asked to report when the pruritus has decreased to a level at which they would not normally seek treatment, as well as when it has completely resolved.
The evolution of oral pruritus will be assessed using an 11-point Numeric Rating Scale (ICH NRS). Pruritus intensity will be measured every 30 seconds during the first 5 minutes after administration of the study intervention and then every 1 minute until 15 minutes post-intervention.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ginevra Lacatusu
- 电话号码：2670 514-345-4931
- 邮箱：ginevra.lacatusu.hsj@ssss.gouv.qc.ca
学习地点
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Quebec
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Montreal、Quebec、加拿大、H2X 0C1
- CHUM
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接触：
- Philippe Bégin
- 电话号码：2668 514-345-4931
- 邮箱：philippe.begin.med@ssss.gouv.qc.ca
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Montreal、Quebec、加拿大、H3T1C5
- Chu Sainte-Justine
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接触：
- Maitena montuzet
- 电话号码：117375 514-345-4931
- 邮箱：maitena.montuzet.hsj@ssss.gouv.qc.ca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 8 years and older.
- Have a clinically diagnosed IgE-mediated food allergy, supported by a compatible clinical history and evidence of IgE sensitization (e.g., skin prick testing and/or serum food-specific IgE), as determined by the treating allergist.
- Undergoing an oral food challenge or initiating oral immunotherapy / undergoing an oral immunotherapy dose escalation.
- Develop oral pruritus following allergen administration with a minimum score of 3/10 on the ICH Numeric Rating Scale (ICH NRS).
- Be able to assess and report their symptoms using the ICH NRS.
- Provide informed consent to participate in the study (and assent, where applicable, in accordance with local regulations).
Exclusion Criteria:
- Any oral condition or pathology that could interfere with the perception, assessment, or interpretation of oral pruritus symptoms.
- Presence or development of systemic allergic symptoms for which epinephrine administration would be clinically indicated.
- Poorly controlled diabetes mellitus, as defined by the treating physician.
- Any condition affecting oral sensation or the ability to accurately communicate symptoms using the ICH NRS.
- Cold urticaria or significant hypersensitivity to cold.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Sucrose only
3.5 g granulated sugar |
Sucrose only (3.5 g granulated sugar) |
|
有源比较器：Cold only
20 mL of ice in the form of popsicle |
Cold only (20 mL of ice in the form of popsicle) |
|
有源比较器：Sucrose and cold
20 mL frozen sucrose solution |
Sucrose + cold (20 mL frozen sucrose solution) |
|
安慰剂比较：Water
20 mL room-temperature water |
20 mL room-temperature water |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under the curve (AUC) of ICH NRS scores
大体时间：From baseline (pre-intervention) through 15 minutes post-intervention.
|
Pruritus intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate greater pruritus intensity and therefore a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to reduction of at least 2 points from the baseline ICH NRS score.
大体时间：From baseline (pre-intervention) through 15 minutes post-intervention.
|
A reduction of at least 2 points on the 11-point Numerical Rating Scale (0-10) indicates an improvement in pruritus intensity. |
From baseline (pre-intervention) through 15 minutes post-intervention.
|
|
Time to complete resolution of oral pruritus (ICH NRS score of 0).
大体时间：From baseline (pre-intervention) through 15 minutes post-intervention.
|
Complete resolution of oral pruritus is defined as an Intra-episode Clinical Numerical Rating Scale (ICH NRS) score of 0, corresponding to no itching. The scale ranges from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus severity and therefore a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
|
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Time to a decrease in oral pruritus intensity to a level at which the participant would normally not seek treatment.
大体时间：From baseline (pre-intervention) through 15 minutes post-intervention.
|
Time from intervention administration to the first assessment at which oral pruritus intensity decreases to a level that the participant reports would not normally prompt them to seek treatment. Pruritus intensity is assessed using the Intra-episode Clinical Numerical Rating Scale (ICH NRS), ranging from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus intensity and a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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