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 |
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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
|
|
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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
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Intervention / Comparator Agent
|
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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
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
Blinding/Masking
|
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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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