Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.
Full Title of Study: “The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: November 2009
Lymphedema is a common complication for breast cancer therapy. Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.
methods: 42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). A certified nurse worked on Combined Decongestive Therapy in the intervention group in two phases. In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, CDT was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.
- Other: combined decongestive therapy
- Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.
- Device: pneumatic compression pump
- Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk
Arms, Groups and Cohorts
- Experimental: CDT and pneumatic compression pump
- combined decongestive therapy consists of the pressure of bandage, manual lymphatic drainage, and exercises that increase the flow of lymph and skin care are used. Intermittent pneumatic pump is not as a part of CDT, but it can be used as an adjunct method. This device according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk.
- No Intervention: not CDT and pneumatic compression pump
- Patients in the control group received no treatment for lymphedema but were placed on the waiting list for CDT as soon as possible after the 8 weeks follow-up period.
Clinical Trial Outcome Measures
- changes in the body image
- Time Frame: change from baseline body image at 8 weeks
- Body image evaluated with the body image and relationships scale. Body image and relationships scale is a questionnaire that consists of 32 items in the three subscales or factors, named strength and health, social barriers, and appearance and sexuality. Higher scores on each subscale indicated greater impairment.
Participating in This Clinical Trial
1. histoty of breast cancer,
2. history of surgery and chemotherapy and as needed hormone therapy and radiotherapy,
3. affected by lymphedema (with degree of mild to severe) based on specialist diagnosis,
4. at least 1 year ago was undergone axillary node dissection,
5. do not have knowledge about combined decongestive therapy,
6. phone accessibility,
7. 35-70 years old.
1. psychotic disorder,
2. existence sever pain at axillary area,
3. history of hysterectomy duo to uterus cancer,
4. severe cardiac disease,
5. heart failure,
6. renal failure,
7. severe hypertension,
8. existing other malignancies,
9. recurrent infection in arm,
10. musclo skeletal disease
Gender Eligibility: Female
Minimum Age: 35 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- badri jaafari
- Provider of Information About this Clinical Study
- Sponsor-Investigator: badri jaafari, faculty member of IAUKazeroun – Islamic Azad University, Kazeroun
- Overall Official(s)
- badri jaafari, author, Study Chair, Department of Nursing, College of Nursing & Midwifery, Kazeroun Azad University, Kazeroun, Iran
Isaksson G, Feuk B. Morbidity from axillary treatment in breast cancer–a follow-up study in a district hospital. Acta Oncol. 2000;39(3):335-6.
Citations Reporting on Results
Kaviani A, Lotfi M. Control of lymphedema after breast cancer treatment. 1st ed. Tehran: Tehran university of medical
Didem K, Ufuk YS, Serdar S, Zümre A. The comparison of two different physiotherapy methods in treatment of lymphedema after breast surgery. Breast Cancer Res Treat. 2005 Sep;93(1):49-54.
Nielsen I, Gordon S, Selby A. Breast cancer-related lymphoedema risk reduction advice: a challenge for health professionals. Cancer Treat Rev. 2008 Nov;34(7):621-8. doi: 10.1016/j.ctrv.2007.11.002. Epub 2008 Aug 8. Review.
Hormes JM, Lytle LA, Gross CR, Ahmed RL, Troxel AB, Schmitz KH. The body image and relationships scale: development and validation of a measure of body image in female breast cancer survivors. J Clin Oncol. 2008 Mar 10;26(8):1269-74. doi: 10.1200/JCO.2007.14.2661.
Ridner SH. The psycho-social impact of lymphedema. Lymphat Res Biol. 2009;7(2):109-12. doi: 10.1089/lrb.2009.0004.
Pain SJ, Purushotham AD. Lymphoedema following surgery for breast cancer. Br J Surg. 2000 Sep;87(9):1128-41. Review.
Földi M. Lymphology in the second millennium. Lymphology. 2001 Mar;34(1):12-21.
Harris SR, Hugi MR, Olivotto IA, Levine M; Steering Committee for Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001 Jan 23;164(2):191-9.
Uzkeser H, Karatay S, Erdemci B, Koc M, Senel K. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. 2015 May;22(3):300-7. doi: 10.1007/s12282-013-0481-3. Epub 2013 Aug 8.
Irdesel J, Celiktas SK. Effectiveness of exercise and compression garments in the treatment of breast cancer related lymphedema- Original article. Turk J Phys Med Rehab, 2007;53:16-21.
Passik S, Newman M, Brennan M, Holland J. Psychiatric consultation for women undergoing rehabilitation for upper-extremity lymphedema following breast cancer treatment. J Pain Symptom Manage. 1993 May;8(4):226-33.
Pruzinsky T. Enhancing quality of life in medical populations: a vision for body image assessment and rehabilitation as standards of care. Body Image. 2004 Jan;1(1):71-81.
Passik SD, McDonald MV. Psychosocial aspects of upper extremity lymphedema in women treated for breast carcinoma. Cancer. 1998 Dec 15;83(12 Suppl American):2817-20. Review.
Speck RM, Gross CR, Hormes JM, Ahmed RL, Lytle LA, Hwang WT, Schmitz KH. Changes in the Body Image and Relationship Scale following a one-year strength training trial for breast cancer survivors with or at risk for lymphedema. Breast Cancer Res Treat. 2010 Jun;121(2):421-30. doi: 10.1007/s10549-009-0550-7. Epub 2009 Sep 22.
Poorkiani M, Abbaszadeh A, Hazrati M, Jafari P, Sadeghi M, Mohammadianpanah M. The effect of rehabilitation on quality of life in female breast cancer survivors in Iran. Indian J Med Paediatr Oncol. 2010 Oct;31(4):105-9. doi: 10.4103/0971-5851.76190.
Teo I, Novy DM, Chang DW, Cox MG, Fingeret MC. Examining pain, body image, and depressive symptoms in patients with lymphedema secondary to breast cancer. Psychooncology. 2015 Nov;24(11):1377-83. doi: 10.1002/pon.3745. Epub 2015 Jan 20.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.