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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: PHYSICAL THERAPY

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: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69710
    • Assuta Medican Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: PHYSICAL THERAPY; EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
Active Comparator: Breast surgery and no exercise; Patient after breast surgery alone are discharged without exercise and instructions.	Other: PHYSICAL THERAPY; EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
Active Comparator: 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.	Other: PHYSICAL THERAPY; EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
Active Comparator: 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.	Other: PHYSICAL THERAPY; EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain	The intensity of pain and chronological modification will be monitored	6 mnth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function of upper limb	The mobility of the shoulder will be evaluates in all movements	six month
Complications	Possible complications after surgery will be recorded	six month
Lymph edema	Radius of upper limb will be measured	6 mnth
physical activities influence in recovery after breast cancer surgery	patient will be agruped by intensity and frequency of PA	6 mnth

Collaborators and Investigators

• Sponsor: Assuta Medical Center
• Investigators: Study Director: Sergio G Susmallian, MD, Assuta Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer; Physiotherapy; Breast surgery; Shoulder pain; Shoulder motion
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AMC2020-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No