Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

NCT07201194 — Not applicable, Recruiting, 90 participants, Vejle Hospital

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

Registry	NCT07201194
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, supportive care
Enrollment	90 (Estimated)
Sponsor	Vejle Hospital (Other)
Conditions	Breast Cancer, Prostate Cancer, Lung Cancer, Gynaecologic Cancer, Colorectal Cancer, Pancreatic Cancer Metastatic
Interventions	Holistic acupuncture and acupressure, Standard medical treatment (Other)
Dates	start 2025-11-17, primary completion 2027-04-01 (estimated), completion 2027-12-31 (estimated), first posted 2025-10-01, last updated 2026-05-28
Locations	1 site in Denmark

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Holistic acupuncture and acupressure	Experimental	Other: Holistic acupuncture and acupressure	Holistic acupuncture and acupressure as a supplement to standard care
Standard care	Active comparator	Other: Standard medical treatment

Holistic acupuncture and acupressure (Other): 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 needles will be used, regardless of whether a deficiency or excess condition is identified. The acupuncture needles used are CAIR Super Silicon CSC-1, size 0.20 × 25 mm. The needles are inserted perpendicularly, except for Yin Tang, which is inserted transversely. The needles will remain in place for 25 minutes.
Standard medical treatment (Other): Standard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health.

+Outcome measures

Primary outcomes

Patient reported nausea assessed on the EORTC-15-PAL Scale [8 days after enrollment]

Secondary outcomes

Patient reported symptom intensity according to the EORTC-15 PAL Scale [8 and 22 days after enrollment]

Other outcomes

Patient reported use of antiemetic medicine [8 and 22 days after enrollment]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Oncology, Vejle Hospital	Vejle	Denmark	Recruiting

+Investigators

Mette Stie, Phd, Principal investigator, Department of Oncology, Lillebaelt Hospital, Vejle