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Recruiting NCT07201194

Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

No phase Interventional Breast Cancer Prostate Cancer Lung Cancer Gynaecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Holistic acupuncture and acupressure, Standard medical treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Gynaecologic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

Overview

The study explores whether acupuncture as a supplement to conventional antiemetic medicine is superior in reducing the level of chemotherapy induced nausea compared to conventional anitemetic medicine alone. A total of 90 patients experiencing chemotherapy induced nausea will be allocated 1:1 to either acupuncture and antiemetic medicine or antiemetic medicine alone. The level of nausea and other cancer related symptoms will be assessed at baseline and 8 and 22 days after enrollment

Interventions

  • Other Holistic acupuncture and acupressure
    The intervention consists of one holistic and individualized consultation with an oncologist trained in acupuncture, in connection with outpatient chemotherapy. The consultation follows the principles of Traditional Chinese Medicine (TCM). The theoretical framework applied is Zang-Fu, which describes organ imbalances and aligns closely with Western medical understanding. Based on individual assessment and anamnesis, the patient receives acupuncture combined with acupressure. A maximum of 10 ne
  • Other Standard medical treatment
    Standard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health.

Primary outcome measures

  • Patient reported nausea assessed on the EORTC-15-PAL Scale [Time frame: 8 days after enrollment]
Secondary outcome measures (1)
  • Patient reported symptom intensity according to the EORTC-15 PAL Scale [Time frame: 8 and 22 days after enrollment]

Eligibility criteria

Inclusion criteria

  • ≥ 18 years of age
  • Undergoing chemotherapy and experiencing nausea despite adherence to the prescribed antiemetic regimen
  • Understands and speaks Danish
  • Written and orally informed consent
  • Planned for treatment every 14 days
  • At least two chemotherapy cycles planned at the time of inclusion

Exclusion criteria

  • Brain metastases
  • Performance status >2

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Department of Oncology, Vejle Hospital — Vejle

Identifiers

NCT: NCT07201194 · HOL-AKU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗