Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

NCT ID: NCT07201194

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard care

Group Type ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type OTHER

Standard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health.

Holistic acupuncture and acupressure

Holistic acupuncture and acupressure as a supplement to standard care

Group Type EXPERIMENTAL

Holistic acupuncture and acupressure

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mette Stie, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Lillebaelt Hospital, Vejle

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mette Stie, PhD

Role: CONTACT

+4579409174

Nanna Nordestgaard Madsen, MScN

Role: CONTACT

+4579406095

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HOL-AKU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acupuncture in Palliative Cancer Care
NCT00302185 COMPLETED PHASE3
Limiting Chemotherapy Side Effects by Using Moxa
NCT02781155 UNKNOWN PHASE1/PHASE2