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 range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Individuals presenting with clinically diagnosed conditions or pathologies known to contribute to fatigue and persons whose fatigue could be attributed to pre-existing conditions