Clinical trial · Interventional
Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)
Prevention of Secondary Lymphedema by Utilizing Self-management Education in Conjunction With Acupuncture Among Breast Cancer Patients Who Are at High Risk of Developing Lymphedema
- 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)
Introduction: Breast cancer women who are treated with axillary node dissection are at increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and the risk can significantly increase with chemotherapy and radiation therapy Objectives: 1. To evaluate the feasibility and effectiveness of implementing the integrative therapy program (ITP) intervention. ITP consists of self-management education in conjunction with acupuncture. 2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain, and early detection and management of lymphedema. Design: the exploratory study aims to evaluate the feasibility and benefits of the integrative therapy program (ITP) intervention post-operatively for 18 months. Subjects: Women with breast cancer treated with axillary node dissection with normal baseline pre-operative bioimpedance (L-dex U400) score. Sample size: 30 subjects
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 |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITP | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ITP (Integrative Thearpy Program)
- description
- This ITP intervention consists of two distinct phases, Phase I, the active treatment phase and Phase II, the follow-up phase. Phase I (Intervention phase) begins post-operatively in 4-6 weeks with a baseline visit that includes 30-minute acupuncture treatment, followed by the 30-minute self-management educational session, and the participants will return weekly for 10 weeks. Phase II (Follow up phase) begins at month 6 and ends at month 18 from the surgery. The phase II consists of 1-hour quarterly ITP therapy at months 6, 9, 12, 15, and 18 and monthly telephone visits between ITP therapies at months 7, 8, 10, 11, 13, 14, 16, and 17. Self-management reinforcement and support will be implemented during telephone follow up visits
- interventionNames
- Other: ITP
Primary outcomes (2)
- measure
- Bioimpedance (L-dex U400)
- timeFrame
- 18 months
- description
- use L-dex machine
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must be able to read and understand the informed consent form and have the capacity to give consent. 2. Adults age 18 and older 3. Subject with a newly diagnosed stage I-III breast cancer with a documented pre-operative baseline L-Dex U400 who underwent axillary lymph node dissection within 4-6 weeks prior to enrollment. 4. Subjects must be able to return to the study site for the duration of the study (18 months). Exclusion Criteria: 1. Subjects who do not read or understand the informed consent are ineligible. 2. Subjects who have any contraindications to the affected upper-limb exercises, which include congestive heart failure, cardiac arrhythmia, deep vein thrombosis, infectious disease complications such as cellulitis and lymphangitis. 3. Women with double mastectomy with axillary node dissection bilaterally. 4. Women with a prior history of axillary surgeries in the ipsilateral side and/or primary lymphedema 5. Women with metal implants (e.g. shoulder replacement) or cardiac implants (e.g. automated implanted cardiac defibrillator (AICD) or pacemaker). 6. All subjects with objective or subjective signs and symptoms of lymphedema. 7. Women of childbearing age who are pregnant.
References
Publications (24)
- BACKGROUNDArmer JM, Brooks CW, Stewart BR. Limitations of self-care in reducing the risk of lymphedema: supportive-educative systems. Nurs Sci Q. 2011 Jan;24(1):57-63. doi: 10.1177/0894318410389058. PMID 21220577
- BACKGROUNDArmer JM, Shook RP, Schneider MK, Brooks CW, Peterson J, Stewart BR. Enhancing Supportive-Educative Nursing Systems to Reduce Risk of Post-Breast Cancer Lymphedema. Self Care Depend Care Nurs. 2009 Oct;17(1):6-15. PMID 22872189
- BACKGROUNDBeaulac SM, McNair LA, Scott TE, LaMorte WW, Kavanah MT. Lymphedema and quality of life in survivors of early-stage breast cancer. Arch Surg. 2002 Nov;137(11):1253-7. doi: 10.1001/archsurg.137.11.1253. PMID 12413312
- BACKGROUNDBinkley JM, Harris SR, Levangie PK, Pearl M, Guglielmino J, Kraus V, Rowden D. Patient perspectives on breast cancer treatment side effects and the prospective surveillance model for physical rehabilitation for women with breast cancer. Cancer. 2012 Apr 15;118(8 Suppl):2207-16. doi: 10.1002/cncr.27469. PMID 22488695
- BACKGROUNDBodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469. PMID 12435261
- BACKGROUNDCassileth BR, Van Zee KJ, Chan Y, Coleton MI, Hudis CA, Cohen S, Lozada J, Vickers AJ. A safety and efficacy pilot study of acupuncture for the treatment of chronic lymphoedema. Acupunct Med. 2011 Sep;29(3):170-2. doi: 10.1136/aim.2011.004069. Epub 2011 Jun 18. PMID 21685498
- BACKGROUNDCemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available. PMID 21802319