The effect of combined decongestive therapy and pneumatic compression pump on lymphedema indicators and body image in patients with lymphedema secondary to breast cancer treatment
Introduction: This study evaluated the effect of combined decongestive therapy (CDT) and pneumatic compression pump on lymphedema indicators in patients with lymphedema secondary to breast cancer treatment.
Materials and methods:
42 women with breast cancer-related lymphedema participated. The volume difference of the upper limbs, upper limb circumference at 9 areas and shoulder joint range of motion were measured in all patients. Then they were divided randomly into an intervention (n=21) or control group (n=21). CDT in the intervention group was done in two phases. In the first phase CDT was performed with a compression pump for 4 weeks, 3 days per week. In the second phase, CDT was performed daily without a pump for 4 consecutive weeks by patients at home. At the end of each phase, the same primary measurements were done for both groups.
General information
Acronym
CDT+ PCP
IRCT registration information
IRCT registration number:IRCT138902212621N8
Registration date:2011-04-30, 1390/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-30, 1390/02/10
Registrant information
Name
Marzieh Moattari
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
moattarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz university of medical sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined decongestive therapy and pneumatic compression pump on lymphedema indicators and body image in patients with lymphedema secondary to breast cancer treatment
Public title
The effect of combined decongestive therapy and pneumatic compression pump on lymphedema indicators and body image in patients with lymphedema secondary to breast cancer treatment
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 35 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Shiraz university of medical sciences
Street address
Zand St.
City
Shiraz
Postal code
71345-1978
Approval date
1990-01-01, 1368/10/11
Ethics committee reference number
CT-88-4919
Health conditions studied
1
Description of health condition studied
postmastectomy lymphedema
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphoedema syndrome
Primary outcomes
1
Description
differences in volume of both upper limbs
Timepoint
before the intervention, 4 and 8 weeks after that
Method of measurement
volumeter
2
Description
difference in circumference between the two upper limbs
Timepoint
before the intervention, 4 and 8 weeks after that
Method of measurement
meter
3
Description
shoulder joint range of motion
Timepoint
before the intervention, 4 and 8 weeks after that
Method of measurement
goniometer
4
Description
body image and relationships
Timepoint
before the intervention, 4 and 8 weeks after that
Method of measurement
body image and relationships scale (questionare)
Secondary outcomes
1
Description
adduction motion of shoulder joint
Timepoint
before the intervention, 4 and 8 weeks after that
Method of measurement
goniometer
Intervention groups
1
Description
Patients in in the control group received no treatment for lymphedema.
Category
N/A
2
Description
CDT in the intervention group was done in two phases. In the first phase CDT was performed with a compression pump for 4 weeks, 3 days per week. In the second phase, CDT was performed daily without a pump for 4 consecutive weeks by patients at home.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mottahari theraputic center
Full name of responsible person
Dr. Marzieh Moattari
Street address
Nemazi square, Zand St.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Dabbagh manesh
Street address
Vice chancellor for research center, Shiraz university of medical sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
CT-88-4919
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Badri Jaafari
Position
MSc in Medical-Surgical Nursing
Other areas of specialty/work
Street address
unit 13, block 12, phase 2, Isargaran appartments, Emam Kkomeini St.
City
Shiraz
Postal code
7178899449
Phone
+98 71 1835 2694
Fax
Email
jafary_227@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PHD in nursing education
Other areas of specialty/work
Street address
College of Nursing & Midwifery, Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
moattari@yahoo.com , moattarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr marzieh Moattari
Position
PhD in Nursing education
Other areas of specialty/work
Street address
College of Nursing & Midwifery, Nemazi Square, Zand St.
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
moattari@yahoo.com , moattarm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)