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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PHYSICAL THERAPY
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring Breast surgery, Physiotherapy, Breast Cancer, Shoulder pain, Shoulder motion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assuta Medican Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Breast surgery and exercise

Breast surgery and no exercise

Breast, axilar surgery with exercise

Breast, axillar surgery without exercise

Arm Description

Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.

Patient after breast surgery alone are discharged without exercise and instructions.

Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.

The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.

Outcomes

Primary Outcome Measures

Shoulder pain
The intensity of pain and chronological modification will be monitored

Secondary Outcome Measures

Full Information

First Posted
December 26, 2017
Last Updated
January 22, 2021
Sponsor
Assuta Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03389204
Brief Title
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
Official Title
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast surgery, Physiotherapy, Breast Cancer, Shoulder pain, Shoulder motion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT intervention and not intervention
Masking
Participant
Masking Description
Participants were blinded to physical support or not
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast surgery and exercise
Arm Type
Active Comparator
Arm Description
Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.
Arm Title
Breast surgery and no exercise
Arm Type
Active Comparator
Arm Description
Patient after breast surgery alone are discharged without exercise and instructions.
Arm Title
Breast, axilar surgery with exercise
Arm Type
Active Comparator
Arm Description
Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.
Arm Title
Breast, axillar surgery without exercise
Arm Type
Active Comparator
Arm Description
The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.
Intervention Type
Other
Intervention Name(s)
PHYSICAL THERAPY
Intervention Description
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
Primary Outcome Measure Information:
Title
Shoulder pain
Description
The intensity of pain and chronological modification will be monitored
Time Frame
6 mnth
Other Pre-specified Outcome Measures:
Title
Function of upper limb
Description
The mobility of the shoulder will be evaluates in all movements
Time Frame
six month
Title
Complications
Description
Possible complications after surgery will be recorded
Time Frame
six month
Title
Lymph edema
Description
Radius of upper limb will be measured
Time Frame
6 mnth
Title
physical activities influence in recovery after breast cancer surgery
Description
patient will be agruped by intensity and frequency of PA
Time Frame
6 mnth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio G Susmallian, MD
Organizational Affiliation
Assuta Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Assuta Medican Center
City
Tel Aviv
ZIP/Postal Code
69710
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The patient will be evaluated after discharge by meetings or though video calls/
IPD Sharing Time Frame
February 01 2019
IPD Sharing Access Criteria
Physiotherapy after breast cancer surgery
Citations:
PubMed Identifier
34800988
Citation
Klein I, Kalichman L, Chen N, Susmallian S. A comprehensive approach to risk factors for upper arm morbidities following breast cancer treatment: a prospective study. BMC Cancer. 2021 Nov 20;21(1):1251. doi: 10.1186/s12885-021-08891-5.
Results Reference
derived

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

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