Clinical Trial: Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Universität Duisburg-Essen
Current Primary Outcome: Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
Original Primary Outcome: Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
Current Secondary Outcome:
- Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
- Xerostomia (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
- Stomatitis (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
- Appetite (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
- Impairment (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
- Adverse Events (free text) [ Time Frame: 7 days ]
Original Secondary Outcome:
- Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
- Xerostomia (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
- Stomatitis (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
- Appetite (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
- Adverse Events (free text) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
Information By: Universität Duisburg-Essen
Dates:
Date Received: November 19, 2014
Date Started: January 2015
Date Completion: December 2018
Last Updated: February 20, 2017
Last Verified: February 2017