Pasadena, California 91105


Purpose:

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


Study summary:

Recruitment and Intervention: The study participants are recruited by their breast surgeon after they undergo axillary node dissection surgery. 4-6 weeks following surgery, the participants will receive a combination of acupuncture and self management education . Contents of self-management education include: 1. Lymphedema knowledge: functions of the lymphatic system, anatomy of the lymph nodes and direction of the lymphatic drainage, risk factors that could precipitate lymphedema, the signs and symptoms of lymphedema and infection, and lymphedema resources. 2. Selfcare techniques:healthy diet (eating whole food encouraged), neck, shoulder and chest wall stretching exercises, walk daily, self-manual lymphatic drainage with deep breathing techniques, and self-acupressure over eighteen months following their surgery. Outcome measurements include: L-Dex U400 measurement, arm circumference, pain scale, self-efficacy, and lymphedema knowledge, and Functional Assessment of Cancer Therapy-Breast FACT-B.


Criteria:

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.


Study is Available At:


Original ID:

HMH2015.002


NCT ID:

NCT02528539


Secondary ID:


Study Acronym:


Brief Title:

Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Huntington Memorial Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Suzie S Kline, PhD
Principal Investigator
Huntington Hospital
Primary Contact:Suzie S Kline, PhD
626-807-9168
suzie.kline@huntingtonhospital.com
Backup Contact:Jeannie Shen, M.D.
626-356-3167

Study Dates

Start Date:August 2013
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:December 2017
Primary Completion Type:Anticipated
Verification Date:September 2016
Last Changed Date:September 20, 2016
First Received Date:August 17, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Wong-Baker FACES Pain Scale
Time Frame:18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life (Functional Assessment of Cancer Therapy-Breast)
Time Frame:18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Lymphedema Knowledge Scale
Time Frame:18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Self-Efficacy Scale
Time Frame:18 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Arm circumference measurements of the upper limbs using at 4 cm interval
Time Frame:18 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Bioimpedance (L-dex U400)
Time Frame:18 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:ITP
Description:The study participants will receive weekly acupuncture treatment plus education on self-management for 10 weeks after axillary node dissection, then a total of five follow up acupuncture treatments once every 3 months at 6, 9, 12, 15, and 18 months. The education and self management will be reinforced monthly by telephone visit. Acupuncture points include: LI 4, LV3, HT3, SP9, GB 20, KD 3, Yintang, and Ashi points
Arm Name:ITP (Integrative Thearpy Program)
Other Name:Integrative Therapy Program

Study Arms

Study Arm Type:Experimental
Arm Name: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 quar

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Huntington Memorial Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Easom LR. Concepts in health promotion. Perceived self-efficacy and barriers in older adults. J Gerontol Nurs. 2003 May;29(5):11-9.
PMID:12765007
Reference Type:Reference
Citation:Erickson VS, Pearson ML, Ganz PA, Adams J, Kahn KL. Arm edema in breast cancer patients. J Natl Cancer Inst. 2001 Jan 17;93(2):96-111. Review.
PMID:11208879
Reference Type:Reference
Citation:Vicini FA, Kestin L, Chen P, Benitez P, Goldstein NS, Martinez A. Limited-field radiation therapy in the management of early-stage breast cancer. J Natl Cancer Inst. 2003 Aug 20;95(16):1205-10.
PMID:12928345
Reference Type:Reference
Citation:Hibbard JH, Greene J, Overton V. Patients with lower activation associated with higher costs; delivery systems should know their patients' 'scores'. Health Aff (Millwood). 2013 Feb;32(2):216-22. doi: 10.1377/hlthaff.2012.1064.
PMID:23381513
Reference Type:Reference
Citation:Langer I, Guller U, Berclaz G, Koechli OR, Schaer G, Fehr MK, Hess T, Oertli D, Bronz L, Schnarwyler B, Wight E, Uehlinger U, Infanger E, Burger D, Zuber M. Morbidity of sentinel lymph node biopsy (SLN) alone versus SLN and completion axillary lymph node dissection after breast cancer surgery: a prospective Swiss multicenter study on 659 patients. Ann Surg. 2007 Mar;245(3):452-61.
PMID:17435553
Reference Type:Reference
Citation:MacPherson H, Thomas K, Walters S, Fitter M. A prospective survey of adverse events and treatment reactions following 34,000 consultations with professional acupuncturists. Acupunct Med. 2001 Dec;19(2):93-102.
PMID:11829165
Reference Type:Reference
Citation:Mansel RE, Fallowfield L, Kissin M, Goyal A, Newcombe RG, Dixon JM, Yiangou C, Horgan K, Bundred N, Monypenny I, England D, Sibbering M, Abdullah TI, Barr L, Chetty U, Sinnett DH, Fleissig A, Clarke D, Ell PJ. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst. 2006 May 3;98(9):599-609. Erratum in: J Natl Cancer Inst. 2006 Jun 21;98(12):876.
PMID:16670385
Reference Type:Reference
Citation:Meng Z, Garcia MK, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Zhang Y, Zhao Q, Zhao G, Liu L, Spelman A, Palmer JL, Wei Q, Cohen L. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012 Jul 1;118(13):3337-44. doi: 10.1002/cncr.26550. Epub 2011 Nov 9.
PMID:22072272
Reference Type:Reference
Citation:Rottmann N, Dalton SO, Christensen J, Frederiksen K, Johansen C. Self-efficacy, adjustment style and well-being in breast cancer patients: a longitudinal study. Qual Life Res. 2010 Aug;19(6):827-36. doi: 10.1007/s11136-010-9653-1. Epub 2010 Apr 17.
PMID:20401551
Reference Type:Reference
Citation:Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19. doi: 10.1002/cncr.23494.
PMID:18428212
Reference Type:Reference
Citation:Zimmermann A, Wozniewski M, Szklarska A, Lipowicz A, Szuba A. Efficacy of manual lymphatic drainage in preventing secondary lymphedema after breast cancer surgery. Lymphology. 2012 Sep;45(3):103-12.
PMID:23342930
Reference Type:Reference
Citation:Yen TW, Fan X, Sparapani R, Laud PW, Walker AP, Nattinger AB. A contemporary, population-based study of lymphedema risk factors in older women with breast cancer. Ann Surg Oncol. 2009 Apr;16(4):979-88. doi: 10.1245/s10434-009-0347-2. Epub 2009 Feb 5.
PMID:19194754
Reference Type:Reference
Citation:Dobos GJ, Kirschbaum B, Choi KE. The Western model of integrative oncology: the contribution of Chinese medicine. Chin J Integr Med. 2012 Sep;18(9):643-51. doi: 10.1007/s11655-012-1200-1. Epub 2012 Aug 31.
PMID:22936317
Reference Type:Reference
Citation:DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27. Review.
PMID:23540561
Reference Type:Reference
Citation:Dibble SL, Chapman J, Mack KA, Shih AS. Acupressure for nausea: results of a pilot study. Oncol Nurs Forum. 2000 Jan-Feb;27(1):41-7.
PMID:10660922
Reference Type:Reference
Citation:de Valois BA, Young TE, Melsome E. Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. Eur J Oncol Nurs. 2012 Jul;16(3):301-9. doi: 10.1016/j.ejon.2011.07.005. Epub 2011 Sep 13.
PMID:21917515
Reference Type:Reference
Citation:Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013 Feb;29(1):28-40. doi: 10.1016/j.soncn.2012.11.005. Review.
PMID:23375064
Reference Type:Reference
Citation:Cemal 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. Review.
PMID:21802319
Reference Type:Reference
Citation:Cassileth 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
Reference Type:Reference
Citation:Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75.
PMID:12435261
Reference Type:Reference
Citation:Binkley 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. Review.
PMID:22488695
Reference Type:Reference
Citation:Beaulac 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.
PMID:12413312
Reference Type:Reference
Citation:Armer 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
Reference Type:Reference
Citation:Armer 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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.