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New method to treat swelling of arm after breast cancer operation

A Randomized controlled trial to compare efficacy of complete decongestive therapy vs complete decongestive therapy and placement of hydrophobic silicone tube and look for their long term patency by ICG in upper limb lymphedema following ALND in breast cancer.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024372
Enrollment
128
Registered
2020-03-30
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: R223- Localized swelling, mass and lump,upper limb

Interventions

Intervention1: Silicone tubes: The study will be conducted in the Department of Surgical disciplines at AIIMS, New Delhi. All patients reporting to surgery OPD with Upper limb lymphedema following A

Sponsors

Department of Surgical Disciplines
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All operated cases of breast cancer who underwent axillary lymph node dissection with established upper limb lymphedema of stage 2 and 3 involving swelling in arm and forearm with or without hand. 2. Written informed consent.

Exclusion criteria

Exclusion criteria: a) Documented pre- operative difference of b) Upper limb swelling due to deep vein thrombosis c Peripheral arterial disease in upper limb. d) Refused to give consent e) Known allergy to Penicillin f) Acute infection of upper limb,not responding to antibiotics

Design outcomes

Primary

MeasureTime frame
Improvement in upper limb lymphedema will be assessed by clinical finding of decreasing limb girth and volume measurement at the end of 6 months of the follow up period.Timepoint: Improvement in upper limb lymphedema will be assessed by clinical finding of decreasing limb girth and volume measurement at the end of 6 months of the follow up period.

Secondary

MeasureTime frame
1.Improvement in range of movement of shoulder will be assessed by degree of pain free movement using a goniometer. 2. Improvement in Quality of life scores using a LYMQOL ARM questionnaire . 3. Incidence of episodes of DLA( Dermato-lymphangio-adenitis) Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Pritam Yadav

All India Institute of Medical Sciences, New Delhi

dranitadharbhan@yahoo.com9810198239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026