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A study to evaluate the usefulness of wearing a compression sleeve immediately after breast cancer surgery to prevent the arm swelling.

Effectiveness of compression garment in preventing breast cancer-related lymphedema: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010762
Enrollment
340
Registered
2017-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Women aged 18 years and above undergoing axillary lymph node dissection (Axillary clearance) for breast cancer treatment

Interventions

Intervention1: Compression: In addition to usual care, participants in this group will receive a pair of compression garment. Study team will take the arm measurement and provide the compression garme

Sponsors

Tata Memorial Hospital
Lead Sponsor
The University of Sydney Australia
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Breast cancer related lymphedema (Bio-impedance ratio)Timepoint: Baseline, Day of suture removal, 5-7 and 11-13 months following surgery

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Anuradha Daptardar

Tata Memorial Hospital

vinsu24@gmail.com9967414286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026