To compare the effectiveness of Compression pump with Multiple Layered Bandaging in swelling of Arm Developed after surgery of Breast Cancer patients.

To Evaluate The Effect of Intermittent Pneumatic Compression Pump with Multiple Layer Inelastic Lymphoedema Bandaging in Post Surgery Upper limb Lymphoedema of Breast Cancer patients: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011708

Enrollment

126

Registered

2018-02-05

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- BREAST CANCER PATIENTS

Interventions

Intervention1: INTERMITTENT PNEUMATIC COMPRESSION (IPC): patients in study arm will receive IPC along with the standard treatment Control Intervention1: Multiple Layer Inleastic Lymphoedema Bandaging

Eligibility

Inclusion criteria

Inclusion criteria: 1.CA breast patients with secondary lymphoedema only 2. female patients of age group 18-75 years only. 3.Lymphoedema of International Society of Lymphology (ISL) Staging II 4.Post completion of primary treatment excluding hormonal therapy

Exclusion criteria

Exclusion criteria: 1.Patients having bilateral lymphoedema. 2.Patients with recurrent disease 3.Patients with acute neuropathy 4.Patients who received radiation in Axilla 5.Patients with compromised cardiac condition 6.Patients with Upper Limb DVT 7.Patients with acute infections like lymphangitis 8.Patients in palliative care. 9.Patients included in any other similar study. 10.Non compliant patients

Design outcomes

Primary

Measure	Time frame
Primary end point: To compare percentage reduction of affected arm volume between study and control arm in 3 weeks. Secondary end point: 1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. 2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. 3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. 4)To find effect on Pain score 5)To find changes in quality of life. Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.	—

Measure

Time frame

Primary end point: To compare percentage reduction of affected arm volume between study and control arm in 3 weeks. Secondary end point: 1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. 2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. 3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. 4)To find effect on Pain score 5)To find changes in quality of life. Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.

—

Secondary

Measure	Time frame
1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. 2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. 3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. 4)To find effect on Pain score 5)To find changes in quality of life. Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.	—

Measure

Time frame

1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. 2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. 3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. 4)To find effect on Pain score 5)To find changes in quality of life. Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.

—

Countries

India

Contacts

Public ContactMohua Chatterjee

ACTREC, Tata Memorial Centre

dr.m.unique@gmail.com9920324975

Outcome results

None listed

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