Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 288 for:    Lymphedema

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02650297
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
badri jaafari, Islamic Azad University, Kazeroun

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphedema Other: combined decongestive therapy Device: pneumatic compression pump Phase 1 Phase 2

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
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.
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

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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650297


Sponsors and Collaborators
badri jaafari
Investigators
Layout table for investigator information
Study Chair: badri jaafari, author Department of Nursing, College of Nursing & Midwifery, Kazeroun Azad University, Kazeroun, Iran

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

Other Publications:
Layout table for additonal information
Responsible Party: badri jaafari, faculty member of IAUKazeroun, Islamic Azad University, Kazeroun
ClinicalTrials.gov Identifier: NCT02650297     History of Changes
Other Study ID Numbers: IAUKazeroun
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by badri jaafari, Islamic Azad University, Kazeroun:
Lymphedema secondary to breast cancer
Breast cancer
Body image

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases