Trial document




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  DRKS00023348

Trial Description

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Title

Acupuncture in chemotherapy-induced dysgeusia – a randomized controlled trial – AcuDysg

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Trial Acronym

AcuDysg

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URL of the Trial

http://www.iki.usz.ch/forschung/Documents/FF_Studie_Akupunktur_Patienten_Digital_Version%203_Druckerei%20Version_20201118%5b1%5d.pdf

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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).

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023348
  •   2020/11/03
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  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2020-01900, Kanton Zürich Kantonale Ethikkommission
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Secondary IDs

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Health Condition or Problem studied

  •   chemotherapy-induced-dysgeusia caused by one of the following cancer types: breast, ovarian, colorectal, lung cancer, germ cell tumor or sarcoma and lymphomas
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Interventions/Observational Groups

  •   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
  •   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
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Other
  •   Treatment
  •   Parallel
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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.

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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.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/02/24
  •   130
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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, colorectal, lung cancer, 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

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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

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Addresses

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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Ms.  Prof. Dr.  Claudia  Witt 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Kantonsspital St.Gallen Zentrum für integrative Medizin Haus 33
    • Greithstrasse 20
    • 9007  St. Gallen
    • Switzerland
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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Ms.  Prof. Dr.  Claudia  Witt 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Universitätsspital Zürich Institut für komplementäre und integrative Medizin
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    •   +41 43 253 21 33
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    •   acudysg at usz.ch
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Sources of Monetary or Material Support

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    • Kelm-Stiftung
    • CH-8070  Zürich
    • Switzerland
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    • Kantonsspital St.Gallen
    • 9007  St. Gallen
    • Switzerland
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    •   [---]*
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    • Universität Zürich
    • 8091  Zürich
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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