Acupuncture for Chemotherapy-Induced Taste Disorders (AcuDysg)

Switzerland (ICTRP)

ID di studio ICTRP
DRKS00023348 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
Acupuncture in chemotherapy-induced dysgeusia a randomized controlled trial AcuDysg - AcuDysg (ICTRP)

Titolo pubblico
Acupuncture in chemotherapy-induced dysgeusia a randomized controlled trial AcuDysg (ICTRP)

Malattie studiate
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 (ICTRP)

Intervento studiato
Group 1: acupuncture (1x/week over 8 weeks) and acupressure (daily self-acupressure over 8 weeks) for cancer-related fatigue with additional dysgeusia specific acupuncture and acupressure points
Group 2: acupuncture (1x/week over 8 weeks) and acupressure (daily self-acupressure over 8 weeks) for cancer-related fatigue without additional dysgeusia specific acupuncture and acupressure points (ICTRP)

Tipo di studio
interventional (ICTRP)

Disegno dello studio
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: Other; Assignment: parallel; Study design purpose: treatment (ICTRP)

Criteri di inclusione/esclusione
Inclusion criteria: - 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 (ICTRP)

Exclusion criteria: - 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 l
- coexisting MDS
- dont 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

Endpoint primari e secondari
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. (ICTRP)

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. (ICTRP)

Data di registrazione
03.11.2020 (ICTRP)

Inclusione del primo partecipante
24.02.2021 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
acudysg@usz.ch, +41 43 253 21 33, Universit?tsspital Z?rich Institut f?r komplement?re und integrative Medizin (ICTRP)

ID secondari
KEK-ZH-Nr. 2020-01900 (ICTRP)

Risultati-Dati individuali dei partecipanti
No (ICTRP)

Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00023348 (ICTRP)