Acupuncture in chemotherapy-induced dysgeusia – a randomized controlled trial – AcuDysg
- Conditions
- chemotherapy-induced-dysgeusia caused by one of the following cancer types: breast, ovarian, endometrial, pancreas, colorectal, lung, prostate cancer, urothelial carcinoma, germ cell tumor or sarcoma and lymphomas
- Registration Number
- DRKS00023348
- Lead Sponsor
- Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
indication of supportive routine care acupuncture treatment for fatigue, with a fatigue intensity of at least 3 on a numeric rating scale (NRS 1-10)
- dysgeusia of at least 5 on NRS (=moderate dysgeusia, NRS 1-10) in the screening tool (adapted from Zabernigg A. et al., 2010)
- actually treated with a chemotherapy regime that includes taxanes, platinum-based antineoplastic drugs or antrazyclins
- chemotherapy treatment is planned to continue at least 8 weeks after beginning of acupuncture treatment
- breast, ovarian, endometrial, pancreas, colorectal, lung, prostate cancer, urothelial carcinoma, germ cell tumor or sarcoma
- lymphomas with bone marrow infiltration <50% that are under treatment with antrazyclins
- performance status of ECOG 0-1
- can eat normal food without pain or swallowing problems
- internet access and interested to use e-learning
- currently receive acupuncture treatment
- dysgeusia that occurred independently of the chemotherapy treatments of the current cancer
- confirmed positive COVID-19 test with associated dysgeusia prior to chemotherapy treatment
- increased risk of bleeding e.g. caused by haemophilia or platelets<50000 µl
- coexisting MDS
- don’t speak sufficient German
- mucositis and dysgeusia with an impact on nutrition (pain or swallowing problems)
- currently receiving or have a planned radiotherapy during the intervention period (within the next 12 weeks) in the head/neck area
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perceived dysgeusia over 8 weeks, calculated as the mean from two patient reported items on taste, each measured on a numeric rating scale from 1-10 weekly directly after each acupuncture treatment.
- Secondary Outcome Measures
Name Time Method Taste and smell test, at 4 and 8 weeks; weight loss, at 4 and 8 weeks; perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy (diary), with daily measures over 8 weeks and after 12 and 24 weeks; quality of life, at 4, 8, 12 and 24 weeks.