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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02650297
Enrollment
42
Registered
2016-01-08
Start date
2009-10-31
Completion date
2009-12-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

Lymphedema secondary to breast cancer, Breast cancer, Body image

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.

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.

Interventions

OTHERcombined 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.

DEVICEpneumatic 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

Sponsors

badri jaafari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in the body imagechange from baseline body image at 8 weeksBody 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026