Clinical trial · Interventional
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
NCT00646633CI-TRIAL-00022925completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture and patient education | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acupuncture & educ
- description
- Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.
- interventionNames
- Procedure: Acupuncture and patient education
- type
- NO_INTERVENTION
- label
- 2. Standard care
- description
- Patients in the control arm will continue to receive standard care from their physician.
Primary outcomes (1)
- measure
- Fatigue as measured by the Brief Fatigue Inventory
- timeFrame
- prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is between 18 and 65 years of age 2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater 3. Patient is in a stable clinical condition Exclusion Criteria: 1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia) 2. Karnofsky Performance Status below 70 3. Acupuncture treatment in the previous 6 months 4. Fatigue before cancer diagnosis 5. Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview 6. Patient has the potential for serious bleeding due to inherited diseases such as hemophilia 7. Patient is taking medications that are either fatigue-inducing or have sedating properties 8. Patient is unavailable by telephone
References
Publications (5)
- BACKGROUNDHui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. doi: 10.1177/1534735405286109. PMID 16484714
- BACKGROUNDHays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. doi: 10.1177/0163278705275339. PMID 15851771
- BACKGROUNDJohnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31. PMID 18648966
- BACKGROUNDVickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. doi: 10.1200/JCO.2004.04.102. PMID 15117996
- DERIVEDJohnston MF, Hays RD, Subramanian SK, Elashoff RM, Axe EK, Li JJ, Kim I, Vargas RB, Lee J, Yang L, Hui KK. Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complement Altern Med. 2011 Jun 25;11:49. doi: 10.1186/1472-6882-11-49. PMID 21703001