| CTRI Number |
CTRI/2018/04/013055 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effect of compression garment and exercise on upper limb lymphedema in females with operated Breast Cancer. |
|
Scientific Title of Study
|
A study to assess the effect of compression garment plus exercise in Breast cancer related lymphedema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrARUPRATAN GHSH |
| Designation |
TUTOR |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830193132 |
| Fax |
|
| Email |
drarupratan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrARUPRATAN GHSH |
| Designation |
TUTOR |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830193132 |
| Fax |
|
| Email |
drarupratan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrARUPRATAN GHSH |
| Designation |
TUTOR |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830193132 |
| Fax |
|
| Email |
drarupratan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| R.G.Kar Medical College and Hospital
1,Khudiram Bose Sarani.
Kolkata-700004
West Bengal |
|
|
Primary Sponsor
|
| Name |
Dr ARUPRATAN GHOSH |
| Address |
Currently; Department of Physical Medicine and Rehabilitation.Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata-700014.
Previously;Department of Physical Medicine and Rehabilitation,
R.G.Kar Medical College and Hospital,
1,Khudiram Bose Sarani,Kolkata-700004 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrARUPRATAN GHOSH |
R.G.Kar Medical College and Hospital |
Department of Physical Medicine and Rehabilitation,
R.G.Kar Medical College and Hospital.
1,khudiram Bose Sarani,
Kolkata
Kolkata
WEST BENGAL |
9830193132
drarupratan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.G.Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post mastectomy upper limb lymphedema in patients with Breast cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Compression garment plus exercises |
1.compression garment that delivers 40 mm Hg pressure.
2.progressive resistance exercise programme for upper limb. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection(sentinel biopsy or axillary dissection).
2,Stage II or III unilateral secondary upper extremity lymphedema.
3.increase in mid arm Girth more than or equal to 2 cm circumferential difference and/or volume more than or equal to 200ml,compared to the uninvolved upper extremity. |
|
| ExclusionCriteria |
| Details |
1.Active Cancer/Metastatic Cancer.
2.Currently receiving or have plans for adjuvant radiation or chemotherapy.
3.pregnancy
4.Presence of other extremity lymphedema.
5.Permanent Pacemaker implanted.
6.Artificial joints in the upper extremities.
7.Renal failure.
8.Arterial insufficiency.
9.Congestive Heart failure.
10.Chronic inflammatory conditions.
11.History of deep vein thrombosis(DVT).
12.Previous treatment with low level Laser.
13.Medication(s) known to affect body fluid balance.
14.Body Mass Index(BMI)greater than 40(morbid obesity) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Volumetric change in affected upper limb.
2.improvement in Hand and arm function.
improvement in quality of life. |
1.Volumetric change in affected upper limb.
2.improvement in Hand and arm function.
improvement in quality of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2016 |
| Date of Study Completion (India) |
20/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Pre- and Post-intervention case series study to assess the effect of compression garment and exercise programme was conducted at R.G.Kar Medical college and Hospital,Kolkata with intention to treat the post mastectomy breast cancer patients with upper limb lymphedema .
The study outcome evaluated by volumetric change of the affected upper limb, along with hand function and quality of life improvement in study subjects.
|