Acupuncture for Chemotherapy-Induced Taste Disorders (AcuDysg)
Zusammenfassung der Studie
We are conducting this project to find out if acupuncture can alleviate taste disorders caused by chemotherapy treatment. Furthermore, we are interested in the influence of acupuncture treatment on other aspects such as quality of life, stress experience, fatigue, nausea and vomiting, weight loss, dry mouth, and sensory disturbances in hands and feet (= peripheral polyneuropathy).
(BASEC)
Untersuchte Intervention
Acupuncture is performed over 8 weeks at weekly intervals. Each acupuncture treatment lasts 30 minutes. All patients receive a weekly acupuncture treatment as part of routine care to improve fatigue. One group additionally receives acupuncture points specifically effective for taste disorders. The control group does not receive any specific acupuncture treatment for taste disorders. Patients also learn acupressure that they can perform daily at home. Before the first acupuncture session, a detailed conversation takes place to clarify whether the treatment is indicated in your case. At the start of treatment, you will receive a questionnaire by mail and after 4, 8, 12, and 24 weeks by email to fill out. Filling out the questionnaire will take approximately 30 minutes each time. The study concludes after 24 weeks. At the beginning of the first acupuncture treatment, we conduct a taste and smell test. We plan about one hour for this test and repeat it at week 4 and 8. Additionally, we ask to check symptoms in a brief diary once a day.
(BASEC)
Untersuchte Krankheit(en)
Taste disorders caused by chemotherapy for the following tumor identities: breast cancer, ovarian cancer, endometrial carcinoma, pancreatic cancer, prostate cancer, urothelial carcinoma, germ cell tumor, lung cancer, colorectal cancer, sarcoma, or lymphoma.
(BASEC)
We are looking for cancer patients who currently suffer from chemotherapy-induced taste disorders as well as fatigue related to cancer disease. Patients must: - be at least 18 years old, - suffer from breast cancer, ovarian cancer, endometrial carcinoma, pancreatic cancer, prostate cancer, urothelial carcinoma, germ cell tumor, lung cancer, colorectal cancer, sarcoma, or lymphoma - and receive chemotherapy with one or more of the following medications (taxanes, platinum-based chemotherapeutics, or anthracyclines) (BASEC)
Ausschlusskriterien
- Taste disorders occurring independently of chemotherapy - Mucositis and taste disorders with impairment of food intake (pain or swallowing difficulties) - Concurrent radiation therapy in the head/neck area (BASEC)
Studienstandort
St Gallen, Zürich
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Universit?tsspital Z?rich Institut f?r komplement?re und integrative Medizin
+41 43 253 21 33
claudia.witt@clutteruzh.ch(ICTRP)
Wissenschaftliche Auskünfte
Institut fr komplementre und integrative Medizin UniversittsSpital Zrich
+41 (0)44 255 23 96
claudia.witt@clutteruzh.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.10.2020
(BASEC)
ICTRP Studien-ID
DRKS00023348 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Acupuncture in chemotherapy-induced dysgeusia a randomized controlled trial AcuDysg - AcuDysg (ICTRP)
Öffentlicher Titel
Acupuncture in chemotherapy-induced dysgeusia a randomized controlled trial AcuDysg (ICTRP)
Untersuchte Krankheit(en)
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)
Untersuchte Intervention
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)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: Other; Assignment: parallel; Study design purpose: treatment (ICTRP)
Ein-/Ausschlusskriterien
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
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
03.11.2020 (ICTRP)
Einschluss des ersten Teilnehmers
24.02.2021 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
acudysg@usz.ch, +41 43 253 21 33, Universit?tsspital Z?rich Institut f?r komplement?re und integrative Medizin (ICTRP)
Sekundäre IDs
KEK-ZH-Nr. 2020-01900 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00023348 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar