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NCT Number: NCT07201194

Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gynaecologic Cancer Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Metastatic Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient reported nausea assessed on the EORTC-15-PAL Scale

    Time frame: 8 days after enrollment

Secondary outcomes

  1. Patient reported symptom intensity according to the EORTC-15 PAL Scale

    Time frame: 8 and 22 days after enrollment

Other outcomes

  1. Patient reported use of antiemetic medicine

    Time frame: 8 and 22 days after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Stie, PhD

CONTACT

[email protected]

+4579409174

Nanna Nordestgaard Madsen, MScN

CONTACT

[email protected]

+4579406095

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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