The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

Lymphedema Clinical Trial

Official title:

The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650297
• Other study ID #: IAUKazeroun
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 29, 2015
• Last updated: January 7, 2016
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Islamic Azad University, Kazeroun
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion criteria:

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.

Exclusion criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
badri jaafari

References & Publications (17)

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. — View Citation

Földi M. Lymphology in the second millennium. Lymphology. 2001 Mar;34(1):12-21. — View Citation

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): — View Citation

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 — View Citation

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.

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. — View Citation

Kaviani A, Lotfi M. Control of lymphedema after breast cancer treatment. 1st ed. Tehran: Tehran university of medical

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. — View Citation

Pain SJ, Purushotham AD. Lymphoedema following surgery for breast cancer. Br J Surg. 2000 Sep;87(9):1128-41. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ridner SH. The psycho-social impact of lymphedema. Lymphat Res Biol. 2009;7(2):109-12. doi: 10.1089/lrb.2009.0004. — View Citation

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. 201 — View Citation

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. — View Citation

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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the body image	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.	change from baseline body image at 8 weeks	Yes

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