Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

NCT07201194 | Recruiting

• 1 other identifier: HOL-AKU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer; Prostate Cancer; Lung Cancer; Gynaecologic Cancer; Colorectal Cancer; Pancreatic Cancer Metastatic

Keywords

acupuncture; chemotherapy induced nauseau

Outcome Measures

Primary Outcomes (1)

• Patient reported nausea assessed on the EORTC-15-PAL Scale

  8 days after enrollment

Secondary Outcomes (1)

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

  8 and 22 days after enrollment

Other Outcomes (1)

• Patient reported use of antiemetic medicine

  8 and 22 days after enrollment

Study Arms (2)

Holistic acupuncture and acupressure

EXPERIMENTAL

Holistic acupuncture and acupressure as a supplement to standard care

Other: Holistic acupuncture and acupressure

Standard care

ACTIVE COMPARATOR

Other: Standard medical treatment

Interventions

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.

Holistic acupuncture and acupressure

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Brain metastases
• Performance status \>2

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Colorectal Neoplasms

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mette Stie, Phd

  Department of Oncology, Lillebaelt Hospital, Vejle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Stie, PhD

CONTACT

+4579409174; mette.stie@rsyd.dk

Nanna Nordestgaard Madsen, MScN

CONTACT

+4579406095; nanna.nordestgaard.madsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The project employs a crossover design, in which the patients participate in both the intervention and the control group. Participants are randomized into two groups: one group receives the intervention first and subsequently serves as the control group, while the other group starts as the control and later receives the intervention. Based on a holistic and individualized consultation, participants in the intervention group will receive one treatment with holistic acupuncture and acupressure in connection with a standard chemotherapy session, including standard supportive care for nausea. The control group will receive standard chemotherapy and supportive care only.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: November 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)