Plain English Summary
Background and study aims
Lymphedema is a long term (chronic) health condition that results in swelling of body tissues, most commonly developing in the arms or legs. It is caused by a problem with the lymphatic system, a network of vessels and glands important in fighting infection and removing excess fluid from body tissues. Secondary lymphedema is caused by damage to the lymphatic system or issues with the draining of excess fluid; this is often due to an infection, injury or cancer treatment. The condition is
common in women treated for breast cancer, the damage often the result of surgery or radiotherapy. The swelling (edema) commonly affects the arm, leading to discomfort, reduced arm movements, pain and diminished quality of life. Quality of life of a patient with lymphedema after a mastectomy (surgery to remove the breast) is an important consideration when treating breast cancer survivors. The aim of this study is to see whether an exercise and home program in addition to conventional treatment results in a better quality of life among postmastectomy lymphedema patients.
Who can participate?
Women aged between 50 and 70 that have had a mastectomy for breast cancer and have developed lymphedema as a result.
What does the study involve?
Participants are allocated to one of two groups depending on whether are assessed for the study on Monday or Wednesday. Those assessed on Monday are assigned to the conventional therapy (CT) group. Those assessed on Wednesday are assigned to the complete decongestive therapy (CDT) group. Participants in the CT group are given manual lymphatic drainage, a low elastic compression garment, gleno-humeral mobilization (a technique for moving the shoulder joint) and deep breathing exercises. Participants in the CDT group are given manual lymphatic drainage, a compression garment, remedial exercises and a home program. Both groups receive treatment 5 times a week for 6 weeks. Their pain and quality of life are assessed at the start of the study and then 4 and 6 weeks into the study.
What are the possible benefits and risks of participating?
The participation is voluntary and there are no potential risks of participation. Benefits may include an improvement in quality of life after treatment.
Where is the study run from?
Maharishi Markendeshwar University Hospital (India)
When is the study starting and how long is it expected to run for?
June 2013 to July 2014
Who is funding the study?
King Saud University (Saudi Arabia)
Who is the main contact?
Mrs Syamala Buragadda
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Syamala Buragadda
ORCID ID
http://orcid.org/0000-0003-2481-1214
Contact details
Rehabilitation Health Sciences Department
College of Applied Medical Sciences
King Saud University
Riyadh
10219
Saudi Arabia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGP-VPP-256-1
Study information
Scientific title
Effect of complete decongestive therapy and home program on health-related quality of life in post mastectomy lymphedema patients.
Acronym
Study hypothesis
Remedial exercises and home program in addition to manual lymphatic drainage and compression bandaging results in better quality of life among postmastectomy lymphedema patients.
Ethics approval
Maharishi Markendeshwar University Ethical Committee, Haryana, 07/09/2013, ref: MMU/MMIPR/013
Study design
This is a mixed factorial design that includes both between and within subjects variables
Primary study design
Interventional
Secondary study design
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Postmastectomy lymphedema
Intervention
Sixty participants were divided into two groups: conventional treatment (CT) group and complete decongestive therapy (CDT) group.
A systematic random sampling procedure was used to include the participants into the study. Volunteer participants assessed on Monday were assigned to the conventional therapy (CT) group, whereas participants assessed on Wednesday were assigned to the complete decongestive therapy (CDT) group. Each group comprised of 30 participants.
1. Conventional therapy (CT) group participants received manual lymphatic drainage, low elastic compression garment, gleno-humeral mobilization and deep breathing exercises
2. Complete Decongestive Therapy (CDT) group received manual lymphatic drainage, compression garment worn 23 hours daily, remedial exercises and a home program
Both groups received treatment 5 times a week for 6 weeks.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Pain measured using the visual analogue score (VAS) at baseline, 4th week and 6th week
2. Health-related Quality of Life, evaluated with the EORTC QLQ C30 and EORTC QLQ-BR23 questionnaires
Measurements were taken at baseline, 4 and 6 weeks.
Secondary outcome measures
Quality of life measured using European Organization of Research and Treatment for Cancer quality of life questionnaire (EORTC QLQ-C30) and the EORTC QLQ-BR23 breast cancer-specific questionnaire.
Measured at baseline, 4th week and 6th week.
Overall trial start date
30/06/2013
Overall trial end date
01/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Females aged between 50 and 70 years
2. Unilateral mastectomy for stage I and II breast cancer
3. Completed radiotherapy and chemotherapy sessions
4. Developed lymphedema more than 3cm compared to contralateral extremity
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Primary lymphedema
2. Bilateral lymphedema
3. Pulmonary edema
4. Congestive heart failure
5. Contraindications limiting therapy
Recruitment start date
01/07/2013
Recruitment end date
01/04/2014
Locations
Countries of recruitment
India
Trial participating centre
Maharishi Markendeshwar University Hospital
Mullana University Road
Mullana
Ambala
Haryana
133207
India
Sponsor information
Organisation
King Saud University
Sponsor details
Rehabilitation Health Sciences Department
College of Applied Medical Sciences
Riyadh
10219
Saudi Arabia
+966 531262956
syamala3110@yahoo.co.in
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
King Saud University
Alternative name(s)
KSU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
Plans for publication in BMC Women's health.
Intention to publish date
04/05/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27145867