Health-related quality of life in postmastectomy lymphedema patients
| ISRCTN | ISRCTN13242080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13242080 |
| Secondary identifying numbers | RGP-VPP-256-1 |
- Submission date
- 27/03/2016
- Registration date
- 07/04/2016
- Last edited
- 25/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Rehabilitation Health Sciences Department
College of Applied Medical Sciences
King Saud University
Riyadh
10219
Saudi Arabia
 ORCID ID |
0000-0003-2481-1214 |
|---|
Study information
| Study design | This is a mixed factorial design that includes both between and within subjects variables |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of complete decongestive therapy and home program on health-related quality of life in post mastectomy lymphedema patients. |
| Study objectives | 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(s) | Maharishi Markendeshwar University Ethical Committee, Haryana, 07/09/2013, ref: MMU/MMIPR/013 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 30/06/2013 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | 1. Primary lymphedema 2. Bilateral lymphedema 3. Pulmonary edema 4. Congestive heart failure 5. Contraindications limiting therapy |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- India
Study participating centre
Mullana
Ambala
Haryana
133207
India
Sponsor information
University/education
Rehabilitation Health Sciences Department
College of Applied Medical Sciences
Riyadh
10219
Saudi Arabia
| Phone | +966 531262956 |
|---|---|
| syamala3110@yahoo.co.in | |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك سعود, KSU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 04/05/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans for publication in BMC Women's health. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/05/2016 | Yes | No |
Editorial Notes
25/09/2017: Internal review.
