A clinical trial to study the effect of scapular and shoulder muscle exercises in preventing arm lymphedema among the breast cancer surgery patients

Recruiting

• Conditions: Malignant neoplasm of breast,

• Registration Number: CTRI/2023/01/049186
• Lead Sponsor: VMahalakshmi Principal investigator

Brief Summary

This study is a randomized, single blinded, parallel group trial comparing the conventional treatment and scapular and shoulder muscle strengthening exercises in preventing arm lymphoedema among the patients who have undergone breast cancer surgery. The study has been planned to conduct for a duration of 10 months. The outcome measures being arm circumference, arm volumetry, muscle strength, shoulder range of motion, shoulder pain and disability, quality of life using inch tape, volumeter, baseline push pull dynamometer, goniometer, SPADI and FACT B questionnaire. It is expected that strengthening exercises will prevent arm lymphedema.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Last Update Posted: 2023-06-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

1 Modified Radical Mastectomy with ALND 2 Breast conservation surgery with ALND 3 Unilateral surgery 4 Neo adjuvant chemotherapy 5 Adjunct Chemotherapy and radiation following surgery 6 First surgery for invasive Breast cancer 7 Patients under Chief Ministers Comprehensive Health Insurance Scheme will be included for our study 8 Patients who agree to be monitored through video call 9 Willingness of patient to participate in the study.

Exclusion Criteria

1 Platelet count < 75,000/ul 2 Hb level < 8% 3 Cardiac Patients [Cardiovascular instability / cardiovascular symptoms at low workloads(<3 metabolic equivalents [METs])] 4 Impaired cognition 5 Patient unable to understand English or Tamil 6 Marked orthopedic and/or musculoskeletal limitations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arm circumference in centimeters	preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Volumetry in millimeters	preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Muscle strength in kilograms	preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Shoulder range of motion in degrees	preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Shoulder pain and disability index in percentage	preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life score higher the score greater the quality of life	Baseline preoperative

Trial Locations

Locations (1)

PSG Institute of Oncology , PSG Hospitals; 🇮🇳 Coimbatore, TAMIL NADU, India

PSG Institute of Oncology , PSG Hospitals

🇮🇳Coimbatore, TAMIL NADU, India

V Mahalakshmi

Principal investigator

9865056677

mahas_v@yahoo.com