Breast Cancer, Colorectal Cancer, Gynaecologic Cancer, Lung Cancer, Pancreatic Cancer Metastatic, Prostate Cancer
Conditions
Keywords
acupuncture, chemotherapy induced nauseau
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
Interventions
OTHERHolistic 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.
OTHERStandard 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.
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported nausea assessed on the EORTC-15-PAL Scale | 8 days after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported symptom intensity according to the EORTC-15 PAL Scale | 8 and 22 days after enrollment |
Countries
Denmark
Contacts
CONTACTMette Stie, PhD
CONTACTNanna Nordestgaard Madsen, MScN
PRINCIPAL_INVESTIGATORMette Stie, Phd
Department of Oncology, Lillebaelt Hospital, Vejle
Outcome results
None listed