Clinical trial · Interventional
Fatigue As a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?
Acupuncture for Fatigue in Breast Cancer Survivors: a Study Protocol for a Pragmatic, Mixed-method, Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression, Anxiety | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture; based on Tradidtional Chinese Medicine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture + usual care
- description
- Participants randomized to acupuncture treatment will receive 12 acupuncture treatments during 8-12 weeks.
- interventionNames
- Other: Acupuncture; based on Tradidtional Chinese Medicine
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Our control group will receive "business as usual". Hence, they will continue with their usual care for their CRF. By inclusion in the study and by the end of it, the participants in the control group will fill in the requested and similar instruments as the participants in the acupuncture group. Further, we will document any medical care they have received during the study period. This includes also life styles advice, and to which point they have followed such advices.
Primary outcomes (2)
- measure
- Fatigue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer survivors, aged 18 or older, not receiving any curative cancer treatment 2. Fatigue score on a VAS scale ≥4 will be eligible 3. Sufficient knowledge of Norwegian is necessary for communicating with the acupuncturist and for filling in and understanding all the Norwegian questionnaires within the study. 4. Participants who have freely agreed to take part in the study and have signed an informed consent form. Exclusion Criteria: 1. Any causal pathology related to fatigue or receiving ongoing acupuncture treatment for fatigue. 2. 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. 3. Potential participants who are unable to understand, speak, or who find it difficult to communicate in Norwegian will be excluded from the study. 4. Individuals presenting with clinically diagnosed conditions or pathologies known to contribute to fatigue and persons whose fatigue could be attributed to pre-existing conditions
References
Publications (1)
- DERIVEDAlraek T, Skjerve H, Sorensen A, Lie SA, Presterud Odegard H, Lu W, Mao J, Deng G, Lee MS, Birch S, Lamu AN, Kim TH, MacPherson H. Acupuncture for fatigue in breast cancer survivors: a study protocol for a pragmatic, mixed method, randomised controlled trial. BMJ Open. 2024 Jul 30;14(7):e077514. doi: 10.1136/bmjopen-2023-077514. PMID 39079925