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

B

badri jaafari

Status and phase

Completed
Phase 2
Phase 1

Conditions

Lymphedema

Treatments

Device: pneumatic compression pump
Other: combined decongestive therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02650297
IAUKazeroun

Details and patient eligibility

About

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 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.

Enrollment

42 patients

Sex

Female

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

CDT and pneumatic compression pump
Experimental group
Description:
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.
Treatment:
Other: combined decongestive therapy
Device: pneumatic compression pump
not CDT and pneumatic compression pump
No Intervention group
Description:
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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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