Fatigue As a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? (NCT04418115) | Clinical Trial Compass
CompletedNot Applicable
Fatigue As a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?
Norway223 participantsStarted 2021-09-01
Plain-language summary
The success of treatment of breast cancer has improved, hence the prevalence of survivors have increased. However, experienced late effects from the cancer itself or from cancer treatment is substantial. Anti-cancer treatment can have a number of side effects including nausea, fatigue, vomiting, anorexia and alopecia. Late effects such as cancer related fatigue (CRF) are very persistent. CRF is a common side effect of cancer therapy, and affects the quality of life of patients and their families. It is important to point out that CRF is a form of fatigue that are different from normal fatigue which everyone can experience every now and then. Acupuncture is increasingly used in cancer centers both in the US and Europe, and that patients are positive to using acupuncture. Albeit the emerging evidence for acupuncture and CRF, acupuncture has neither been offered as a treatment for CRF within a Norwegian hospital nor in general practice. Hence the investigators think there is a need for a large randomized controlled trial (RCT) in a Norwegian health care setting.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Breast cancer survivors, aged 18 or older, not receiving any curative cancer treatment
✓. Fatigue score on a VAS scale ≥4 will be eligible
✓. Sufficient knowledge of Norwegian is necessary for communicating with the acupuncturist and for filling in and understanding all the Norwegian questionnaires within the study.
✓. Participants who have freely agreed to take part in the study and have signed an informed consent form.
Exclusion criteria
✕. Any causal pathology related to fatigue or receiving ongoing acupuncture treatment for fatigue.
✕. Participants who are pregnant at baseline or planning to get pregnant within the treatment period will be excluded. Reason is that several acupuncture points should be avoided during pregnancy and several of those are related to the treatment of fatigue.
✕. Potential participants who are unable to understand, speak, or who find it difficult to communicate in Norwegian will be excluded from the study.
✕
What they're measuring
1
Fatigue
Timeframe: 12 weeks (treatment completion), Change from baseline registration at 3 and 6 month
2
Fatigue 2
Timeframe: Change from baseline registration at 3 and 6 month
. Individuals presenting with clinically diagnosed conditions or pathologies known to contribute to fatigue and persons whose fatigue could be attributed to pre-existing conditions