Clinical trial · Interventional
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
NCT02803736CI-TRIAL-00024890AcupunctureunknownN/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)
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Real acupuncture group
- description
- Patients in the real acupuncture group will receive true acupuncture 3 times a week for 4 weeks (12 sessions). A standardized prescription of six acupuncture points is used unilaterally. Needles are inserted and manipulated manually until needling sensation (de qi) is obtained, and are retained for 20 minutes with manual manipulation at 10 minutes. Acupuncturists are trained to inquire about specific needle sensations when providing true acupuncture.
- interventionNames
- Device: acupuncture
- type
- SHAM_COMPARATOR
- label
- Sham acupuncture group
- description
- Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).
- interventionNames
- Device: acupuncture
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * women who completed all primary and adjuvant treatments. * age between 20 and 45. * BMI between 18 and 28. * unilateral lymphedema resulting from surgery for breast cancer. * mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation. * with no evidence of recurrence. Exclusion Criteria: * bilateral lymphedema. * history of bilateral axillary lymph node dissection. * serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation. * pregnant women. * unable to adhere to the protocol or the treatment schedule. * recurrent breast cancer or other malignancies. * current use of chemotherapy or radiation. * current use of diuretic drugs like Diosmin, or other investigational drugs.
References
Publications (2)
- BACKGROUNDAndersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186. PMID 10987238
- DERIVEDZhu H, Li J, Peng Z, Huang Y, Lv X, Song L, Zhou G, Lin S, Chen J, He B, Qin F, Liu X, Dai M, Zou Y, Dai S. Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial. BMC Complement Altern Med. 2017 Sep 21;17(1):467. doi: 10.1186/s12906-017-1980-0. PMID 28934950