Topical Zinc sulphate for chemotherapy-induced dysgeusia among breast cancer patients receiving Chemotherapy:- Pilot study patients receiving Chemotherapy- Pilot study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in taste perception by taste acuity method
研究概览
简要总结
The study is yet to start the recruitment.
During the second cycle, the patient will be enrolled for the study. Baseline CITAS and taste assessment**using taste strip (details given below) will be done
The participant will be advised to take the entire solution in the mouth and move it around
without swallowing it. Then post procedure CITAS and taste assessment using taste strip will be done to
evaluate immediate effect.
To evaluate the sustained effect of zinc sulfate by swish and spit (Z-SAS), the study intervention will be
given three times a day before each meal for 2 weeks and will be tested for the taste perception using
CITAS and taste strip testing method during the third cycle.
Quality of life assessment The Quality of life score will be assessed by Cancer Institute quality of life scores
at the baseline and at the end of study.
Adverse event monitoring: The frequency of Adverse events that are possibly due to zinc sulphate will be
studied. All patients will be monitored for adverse events during the study period (CTCAE version 5.0)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •patients with breast cancer planned for curative intent therapy (neoadjuvant or adjuvant ) with epirubicin and cyclophosphamide agents during first cycle.
排除标准
- •Patients who had received zinc preparations within the last two weeks of enrolment
- •Known hypersensitivity to the drug
- •Known psychiatric disorder
- •Regular alcohol intake (3 or more drinks equivalent of 45 ml of liquor per week).
结局指标
主要结局
Change in taste perception by taste acuity method
时间窗: Baseline and two weeks
Change in CiTAS score
时间窗: Baseline and two weeks
次要结局
- Adverse drug reaction to Topical Zinc(Over two weeks)
研究者
Dr Mirunalini R
JIPMER, Puducherry