A study to evaluate the usefulness of wearing a compression sleeve immediately after breast cancer surgery to prevent the arm swelling.
Not Applicable
- Conditions
- Health Condition 1: null- Women aged 18 years and above undergoing axillary lymph node dissection (Axillary clearance) for breast cancer treatment
- Registration Number
- CTRI/2017/12/010762
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Women undergoing axillary lymph node dissection (Axillary clearance) for breast cancer treatment
2. >18 years
3.Willing to give informed consent
4.Ability to fill the self-reported questionnaire in any of the four languages (English, Hindi Marathi and Bengali)
5.Available for follow-up assessments
6.No physical impairments that preclude patientsâ?? ability to don and doff garment (e.g., severe OA of the fingers)
Exclusion Criteria
1.Axillary Sampling or Sentinal Lymph node biopsy only.
2.Open wounds
3.Bilateral breast cancer
4.Lymphedema prior to surgery
5.Lymphedema of the ipsilateral arm at baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast cancer related lymphedema (Bio-impedance ratio)Timepoint: Baseline, Day of suture removal, 5-7 and 11-13 months following surgery
- Secondary Outcome Measures
Name Time Method Arm circumference measure by cliniciansTimepoint: Baseline, Day of suture removal, 5-7 and 11-13 months following surgery;Arm circumference measure by patients carerTimepoint: Baseline, every month post surgery;Pitting testTimepoint: Baseline, Day of suture removal, 5-7 and 11-13 months following surgery;Quality of Life (EORTC QLQ-C30) version 3 and breast cancer specific module-23Timepoint: Baseline, Day of suture removal, 5-7 and 11-13 months following surgery