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Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention

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ClinicalTrials.gov Identifier: NCT03389204
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sergio Gabriel Susmallian, Assuta Medical Center

Brief Summary:

Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .

Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.

There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.


Condition or disease
Breast Neoplasms

Detailed Description:

Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.

Hypotheses

  • Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
  • Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.

Methods

Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel

Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Breast surgery and exercise
Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.
Breast surgery and no exercise
Patient after breast surgery alone are discharged without exercise and instructions.
Breast, axilar surgery with exercise
Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.
Breast, axillar surgery without exercise
The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.
Reconstructive breast with exercise
Patients that underwent breast cancer surgery and immediate reconstruction with exercises of the upper limb and instruction to continue after discharge.
Reconstructive breast without exercise
Patients that underwent breast cancer surgery and immediate reconstruction without exercise and discharged without instructions.



Primary Outcome Measures :
  1. Mobility of upper limb [ Time Frame: six month ]
    The mobility of the shoulder will be evaluates in all movements


Secondary Outcome Measures :
  1. lymphedema [ Time Frame: 6 month ]
    Evaluation of lymphedema will be classified in 4 degrees

  2. Shoulder pain [ Time Frame: 6 month ]
    The intensity of pain and chronological modification will be monitored



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are diagnosed with Carcinoma of Breast and underwent any type of breast surgery for cancer
Criteria

Inclusion Criteria:

  • Women
  • Age 18-65.
  • Diagnosed with breast cancer, undergoing breast surgery,
  • Functional independence prior to the operation.
  • Ability to communicate in Hebrew.

Exclusion Criteria:

  • Cognitive disorders, patients unable to sign the consent form.
  • Back and spinal morbidity.
  • Fibromyalgia or chronic pain disorders.
  • Neurological disorders.
  • Renal failure with the need for dialysis.
  • Lymphedema prior to surgery.
  • History of breast surgery.
  • Shoulder surgery or shoulder injuries with limited ROM.
  • Ischemic heart disease, heart failure and radical heart insufficiency.
  • Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389204


Contacts
Contact: Sergio G Susmallian, MD +972524637743 sergio9@bezeqint.net
Contact: Yfat Klain, Ms +972506764695 ifatg@assuta.co.il

Locations
Israel
Assuta Medican Center Not yet recruiting
Tel Aviv, Israel, 69710
Contact: Sergio G Susmallian, MD    972524637743    sergio9@bezeqint.net   
Contact: Yfat Klain, Mrs    972506764695    IfatGoldberg@hotmail.com   
Sponsors and Collaborators
Assuta Medical Center
Investigators
Study Director: Sergio G Susmallian, MD Assuta Medical Center

Responsible Party: Sergio Gabriel Susmallian, Head of the Department of General Surgery, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT03389204     History of Changes
Other Study ID Numbers: AMC2020-17
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The patient will be evaluated after discharge by meetings or though video calls/
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: February 01 2019
Access Criteria: Physiotherapy after breast cancer surgery
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sergio Gabriel Susmallian, Assuta Medical Center:
Breast surgery
Physiotherapy
Breast Cancer
Shoulder pain
Shoulder motion

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases