Breast CancerNCT07201194
Holistic Acupuncture for Patients With Chemotherapy Induced Nausea
A study testing Holistic acupuncture and acupressure and Standard medical treatment in people with Breast Cancer and Prostate Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- Holistic acupuncture and acupressure and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- Brain metastases
- Performance status >2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Vejle Hospital
Vejle, 7100
About this study
Official title: HOL-AKU: 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
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Gynaecologic Cancer, Colorectal Cancer, Pancreatic Cancer Metastatic
- Being tested
- Holistic acupuncture and acupressure, Standard medical treatment
- Keywords
- acupuncture, chemotherapy induced nauseau
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic acupuncture and acupressureOther
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 treatmentOther
Standard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health.
| Study group | Role | What they receive |
|---|---|---|
| Holistic acupuncture and acupressure | Experimental | Holistic acupuncture and acupressure as a supplement to standard care Receives: Other: Holistic acupuncture and acupressure |
| Standard care | Active comparator | Not described Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported nausea assessed on the EORTC-15-PAL Scale
Measured: 8 days after enrollment
Secondary outcomes (1)
Patient reported symptom intensity according to the EORTC-15 PAL Scale
Measured: 8 and 22 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start17 Nov 2025
- Primary completionApr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Stie, Phd, Principal investigator, Department of Oncology, Lillebaelt Hospital, Vejle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201194
- Sponsor's protocol ID
- HOL-AKU
- Status last verified
- May 2026
- First submitted
- 23 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea
- ClinicalTrials.gov ID
- NCT07201194
- Acronym / sponsor ID
- HOL-AKU
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Gynaecologic Cancer, Colorectal Cancer, Pancreatic Cancer Metastatic
- Keywords
- acupuncture, chemotherapy induced nauseau
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Holistic acupuncture and acupressure | Experimental | Other: Holistic acupuncture and acupressureHolistic acupuncture and acupressure as a supplement to standard care |
| Standard care | Active comparator | Other: Standard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- Brain metastases
- Performance status >2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holistic acupuncture and acupressureThe 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. | Other | Holistic acupuncture and acupressure |
| Standard medical treatmentStandard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health. | Other | Standard care |
Primary outcome
Patient reported nausea assessed on the EORTC-15-PAL Scale
Time frame: 8 days after enrollment
1 secondary outcome
Patient reported symptom intensity according to the EORTC-15 PAL Scale
Time frame: 8 and 22 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mette Stie, Phd principal investigator
Department of Oncology, Lillebaelt Hospital, Vejle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic acupuncture and acupressure and Standard medical treatment in people with Breast Cancer and Prostate Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Stie, PhD (+4579409174, mette.stie@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported nausea assessed on the EORTC-15-PAL Scale (time frame: 8 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.