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CTRI Number  CTRI/2018/11/016353 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 21/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Upper Extremity Disability it’s association with Pectoralis Minor Tightness in Breast Cancer Surgery  
Scientific Title of Study   A Study of Upper Extremity Disability it’s association with Pectoralis Minor Index in Patients with or without Lymphedema in post Breast Cancer Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachin Etam 
Designation  Assistant Professor 
Affiliation  Lokmanya Tilak Muncipal Medical College 
Address  Lokmanya Tilak Municipal Medical College and General Hospital, Physiotherapy Department, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai - 400022

Mumbai
MAHARASHTRA
400052
India 
Phone  9892380566  
Fax    
Email  sachinetam@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Bhagyashree Hajare 
Designation  Intern 
Affiliation  Lokmanya Tilak Muncipal Medical College 
Address  Lokmanya Tilak Municipal Medical College and General Hospital, Physiotherapy Department, Dr. Babasaheb Ambedkar Road, Sion (West),

Thane
MAHARASHTRA
400601
India 
Phone    
Fax    
Email  bhagyashreehajare12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhagyashree Hajare 
Designation  Intern 
Affiliation  Lokmanya Tilak Muncipal Medical College 
Address  Lokmanya Tilak Municipal Medical College and General Hospital, Physiotherapy Department, Dr. Babasaheb Ambedkar Road, Sion (West),

Thane
MAHARASHTRA
400601
India 
Phone    
Fax    
Email  bhagyashreehajare12@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and General Hospital, Physiotherapy Department, Dr. Babasaheb Ambedkar Road, Sion (West), 
 
Primary Sponsor  
Name  Dr Sachin Etam 
Address  Lokmanya Tilak Municipal Medical College and General Hospital, Physiotherapy Department, Dr. Babasaheb Ambedkar Road, Sion (West), 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhagyashree Hajare  Lokmanya Tilak Municipal Medical College and General Hospital  Physiotherapy Department, Opd 24 Dr. Babasaheb Ambedkar Road, Sion (West),Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai - 400022
Mumbai
MAHARASHTRA 
9892380566

bhagyashreehajare12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH Lokmanya Tilak Municipal Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Age group : 18 years and above
Breast cancer stage: I, II, III A (TNM Classification)(21)
Literate: Can read and write English/Hindi
Willing to participate
Pectoralis minor muscle must be preserved during surgery
Duration post surgery: 1 month and above
Undergoing Adjuvant chemotherapy
 
 
ExclusionCriteria 
Details  Metastasis
Any neurological condition
Musculoskeletal conditions of hand eg: Rheumatoid arthritis,Osteoarthritis
Previous deformity of hand and hand injuries
Recent upper limb fracture
Chest infection
Contralateral beast cancer
Adjuvant Radiotherapy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Pectoralis Minor Index  
Dash score of last 7 days
Pectoralis Minor Index 7.65 or lower after 1month and 6month after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Lymphedema by circumference measurement
[(Total circumference of affected arm – total circumference of healthy arm) / total circumference of healthy arm] ×100 
Lymphedema after 1 month and 6 month of surgery 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/11/2018 
Date of Study Completion (India) 29/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/01/2019 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is a major health problem and is the second leading cause of cancer deaths in women.(1) 

Due to new treatment modalities, breast cancer survival has improved over time. However, as a result of breast cancer treatment, many patients suffer from adverse effects and have serious complaints in their arm and shoulder e.g. decreased joint mobility, muscle strength, pain and lymphedema, leading to limitations in activities of daily living and participation in work, sports and leisure activities.(2) 

A tremendous improvement in every aspect of breast cancer surgery management has occurred in the last two decades.(3) Breast surgery has evolved from local wide excision, quadrantomy , total mastectomy, radical mastectomy to modified radical mastectomy including Patey-Dyson Mastectomy and Madden-Auchincloss Mastectomy.(4)

It looks at developing ways of reducing the failure and complication rates for the breast reconstruction procedures facilitated by the new mastectomies(4). The Auchincloss mastectomy method was the most popular surgical procedure for breast cancer treatment during the past decade.(5) 

The development of new therapeutic agents and regimens for breast cancer have contributed to reduced risk of recurrence and prolonged patient’s survival.Therefore, a significantly increased number of cancer patients now spend a large proportion of their lives coping with physical, psychological, and social impairments (6) 

Despite developments in surgical techniques and the increased number of breast conserving surgeries, post-operative morbidity in the form of functional impairment and pain is a significant clinical problem. Sequelae and other health problems affecting the arm to the surgery are some of the complications resulting from breast cancer treatment and have a significant impact on the daily life of these patients(7) 

The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire. The items enquire about the degree of difficulty in performing different physical activities (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items) and the impact of the problem on social functioning, work, sleep and self-image (4 items). Each item has five response options. It assesses the whole person’s ability to function, even if the person is compensating with the other limb.The reliability of the DASH Scale is excellent (Interclass Correlational coefficient is 0.97 ) (8) 

After breast cancer surgery, patients suffer from upper-extremity dysfunction, including pectoral muscle tightness (9). The pectoralis minor attaches at the coracoid process of the scapula and at the third, fourth, and fifth ribs near their sternocostal junctions. 

A short pectoralis minor muscle increases the muscles passive tension with arm elevation resulting in restriction of normal scapular movements such as external rotation, upward rotation and posterior tipping and this in turn will affect glenohumeral motion.(10)(11) 

Breast cancer survivors in a post-operative state often display restricted movement of the shoulder on the affected side due to pain, tightness related to surgery and a general protective tendency resulting from fear or anxiety.(12) 

Patients’ efforts to protect their surgical sites through thoracic flexion and scapular protraction may aggravate pectoral muscle shortening(13) Pectoralis minor muscle is in the field of surgery and it is therefore affected.(14) 

The Pectoralis Minor Index is calculated by dividing the resting muscle length measurement by the subject height and multiplying by 100. The resting muscle length is measured between the caudal edge of the 4th rib to the inferomedial aspect of the coracoid process with a measuring tape or sliding calliper. PMI is suggested to reflect a shortened pectoralis minor when 7.65 or lower.(15)[(ICC = 0.91(good to excellent reliability), SEM 0.16% of body length](16) 

Upper extremity lymphedema is a chronic complication that appears frequently after breast cancer treatment. Lymphedema is a factor that mediates significant effects on the function of upper extremities involves a swollen sensation or mild discomfort in the upper extremities(17)

Several symptoms and impairments often occur in lymphedema patients: limitation of joint motion, heaviness, tightness, numbness, weakness and pain (due to brachial plexopathy, peripheral neuropathy, rotator cuff disease, adhesive capsulitis, DeQuervain tenosynovitis) as well as susceptibility to infection of an oedematous limb. (17)(18)

The lymphedema will be determined by the arm circumference measurement at the 7 points of the affected and contralateral side. The size of lymphedema was expressed as the relation between total circumference of healthy and affected arm, and calculated according to the following formula: [(total circumference of affected arm – total circumference of healthy arm) / total circumference of healthy arm] ×100. 

As impairments due to breast cancer can cause functional problems due to reduced range of reduction in motion, decreased shoulder and arm muscles strength. This further causes limitations in use of affected extremity in activities of daily living.(19)

Thus due to advance in treatment, number of patient post surgery survivor is increasing but in them various complications are seen, thus there quality of life decreases, few of the most common complications are upper limb disability, tightness, lymphedema. This study will help to find upper limb disability and its associated with pectoralis minor tightness using Pectoralis minor Index in patients with or without having lymphedema after post surgery in patients with breast cancer.


 
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