Acupuncture in chemotherapy-induced dysgeusia – a randomized controlled trial – AcuDysg
Organizational Data
- DRKS-ID:
- DRKS00023348
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-11-03
- Last update in DRKS:
- 2023-07-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
AcuDysg
URL of the study
No Entry
Brief summary in lay language
We conduct this study in order to investigate if acupuncture can help to reduce taste alternations caused by chemotherapy. We will also evaluate the effects of acupuncture on other aspects like quality of life, stress, tiredness related with cancer (fatigue), nausea and vomiting, loss of weight, mouth dryness as well as the loss of sensations of hands and feet (periphere polyneuropathy).
Brief summary in scientific language
Dysgeusia is a common side effect in patients undergoing chemotherapy with a prevalence between 56% and 76%. To date, there is no effective treatment for dysgeusia. The primary objective is to investigate the effectiveness of an additional dysgeusia-specific acupuncture and self-acupressure intervention compared to a supportive acupuncture and self-acupressure intervention only, regarding chemotherapy-induced dysgeusia in cancer patients receiving chemotherapy.Methods: A total of 130 patients receiving chemotherapy with cancer related fatigue experiencing dysgeusia will be included into a multicenter, randomized, controlled and two-armed single-blind trial. Both groups will receive 8 sessions of acupuncture treatment for cancer-related fatigue over a period of 8 weeks and are trained to do self-acupressure at predefined acupuncture points, once a day during the whole treatment period. The intervention group will receive in addition acupuncture and acupressure points that are dysgeusia specific within the same treatment session.The primary endpoint is the perceived dysgeusia over 8 weeks, calculated as the mean from two patient reported items on taste, each measured on numeric rating scale from 1-10 weekly directly after each acupuncture treatment.Secondary endpoints are the taste and smell test and weight loss at 4 and 8 weeks, perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy measured daily over 8 weeks in a diary and after 12 and 24 weeks; as well as quality of life at 4, 8, 12 and 24 weeks.
Health condition or problem studied
- Free text:
- 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
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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
- Arm 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
Endpoints
- Primary outcome:
- 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:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
- Other
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- Data analyst
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- University medical center Institut für komplementäre und integrative Medizin, Universitätsspital Zürich Zürich, Schweiz
- Medical center Kantonsspital St. Gallen, Zentrum für Integrative Medizin St. Gallen, Schweiz
Recruitment period and number of participants
- Planned study start date:
- 2021-01-04
- Actual study start date:
- 2021-02-24
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-05-25
- Target Sample Size:
- 130
- Final Sample Size:
- 22
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
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 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
Addresses
Primary Sponsor
- Address:
Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
Prof. Dr. Claudia Witt
Sonneggstrasse 6
8091 Zürich
Switzerland
- Telephone:
- +41 (0)44 255 23 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
Prof. Dr. Claudia Witt
Sonneggstrasse 6
8091 Zürich
Switzerland
- Telephone:
- +41 (0)44 255 23 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch/
Contact for Public Queries
- Address:
Universitätsspital Zürich Institut für komplementäre und integrative Medizin
Sonneggstrasse 6
8091 Zürich
Switzerland
- Telephone:
- +41 43 253 21 33
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
Prof. Dr. Claudia Witt
Sonneggstrasse 6
8091 Zürich
Switzerland
- Telephone:
- +41 (0)44 255 23 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch/
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
Kelm-Stiftung
CH-8070 Zürich
Switzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
Kantonsspital St.Gallen
9007 St. Gallen
Switzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
Universität Zürich
8091 Zürich
Switzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
Kantonale Ethikkommission Zürich
Stampfenbachstrasse 121
8090 Zürich
Switzerland
- Telephone:
- (+41)43-2597970
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zh.ch/kek
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-07-22
- Ethics committee number:
- 2020-01900
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-10-13
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Huber C, Zhang L, Schlaeppi M, Müller T, Roll S, Voiss P, Barth J, Driessen C, Witt CM. Acupuncture in chemotherapy-induced dysgeusia (AcuDysg): study protocol of a randomised controlled trial. BMJ Open. 2023 Mar 10;13(3):e066137. doi: 10.1136/bmjopen-2022-066137. PMID: 36898749; PMCID: PMC10008328.
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry
