Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
研究概览
简要总结
This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.
详细描述
Taste disorders are frequent side effects in patients undergoing chemotherapy (CTX). Dysguesia has prevalence rates of 16% to 1000% during CTX with sometimes also persistent courses. Impact of dysguesia on appetite, body weight as well as health-related quality of life was shown. Until now, evidence for adequate treatment options is limited to specific diary recommendations. Acupuncture in the treatment of side effects of chemotherapy was investigated for nausea and xerostomia, but not for dysguesia. Therefore, this randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)
- •Senological, gynecological or internistic tumors
- •Phantogeusia (on average ≥4 NRS)
- •Willingness to participate in the study and written informed consent
排除标准
- •Severe stomatitis
- •Dysgeusia before the CTX based on neurological diseases, diabetes, or the ingestion of drugs with taste disorders as side effects
- •Leucopenia/neutropenia
- •Intake of anticoagulants
- •Severe physical or mental comorbidity (due to which the patient is unable to participate in the study)
- •Participation in other CAM treatments within the integrative oncology care
- •Participation in other studies on the effectiveness of interventions for oral complications
研究组 & 干预措施
Hypoglossal acupuncture
Single treatment of hypoglossal needle acupuncture during the chemotherapy administration: Treated points will be Jinjin (Golden Liquid/EX-HN12) left beside the lingual frenulum and Yuye (Jade Fluid/EX-HN13) right beside the lingual frenulum. Both points are treated in quick succession with immediate removal of the needle.
干预措施: Hypoglossal acupuncture (Other)
Sham acupuncture
Single treatment of hypoglossal sham acupuncture uring the chemotherapy administration: Treated points will be 1 to 1.5 cun (a cun is defined as the width of the patient's thumb at the knuckle) beside the verum acupuncture points Jinjin and Yuye using the dull side of the needle.
干预措施: Sham acupuncture (Other)
Dietary recommendations
This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.
干预措施: Dietary recommendations (Behavioral)
结局指标
主要结局
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
时间窗: 7 days
次要结局
- Appetite (NRS - Numeric Rating Scale)(7 days)
- Xerostomia (NRS - Numeric Rating Scale)(7 days)
- Impairment (NRS - Numeric Rating Scale)(7 days)
- Adverse Events (free text)(7 days)
- Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)(7 days)
- Stomatitis (NRS - Numeric Rating Scale)(7 days)
研究者
Heidemarie Haller
Postdoctoral Research Fellow
Universität Duisburg-Essen