Randomized Controlled Trial to compare efficacy of Decongestive CompressionTherapy and injection Benzathine Penicillin G vs Decongestive CompressionTherapy, injection Benzathine Penicillin - G and Placement of Hydrophobic Siliconetube in upper limb Lymphedema following ALND in breast cancer.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb
Study Overview
Brief Summary
Lymhedema is unavoidable complication post ALND in breast cancer. Staganation of lymph takes place in the arm, with the result, the arm becomes heavy which decreases the movement at joints and deteriorates the quality of life.
Standard of treatment at present is Decongestive Compression Therapy which helps the patient to some extent only. Alternate ways of therapy are being explored that will evacuate the lymph from the lymphedema arm,
resulting in decrease in volume and limb girth, and therefore improve their quality of life. So this is an attempt to use silicone tubes as a artificial lymphatic for drainage of lymph to be placed surgically from dorsum of the hand
to scapular region (Non lymphedema area).
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All operated cases of breast cancer with established upper limb lymphedema of stage 2 and 3 coming to surgery OPD between May 2017 to Dec 2018 will be recruited after proper screening.
Exclusion Criteria
- •Pre operative difference of >2cm in both upper limbs circumference if documented .
- •Upper limb swelling because of deep vein thrombosis
- •Peripheral arterial disease with involvement of upper limb.
- •Refusals for consent.
- •Known allergy to Penicillin.
Outcomes
Primary Outcomes
Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb
Time Frame: Baseline, 1 month, 3 months, and 6 months of the follow up | period.
girth by measuring with tap along the length of arm every 5 cm and volume measurement by water displacement menthod
Time Frame: Baseline, 1 month, 3 months, and 6 months of the follow up | period.
Secondary Outcomes
- 1. Improvement in range of movement of shoulder- assessed by degree of pain free movement using(a goniometer .)