Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03389204|
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : February 13, 2018
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|
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.
- 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.
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|
|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 :||April 1, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
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.
- Mobility of upper limb [ Time Frame: six month ]The mobility of the shoulder will be evaluates in all movements
- lymphedema [ Time Frame: 6 month ]Evaluation of lymphedema will be classified in 4 degrees
- Shoulder pain [ Time Frame: 6 month ]The intensity of pain and chronological modification will be monitored
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
|Contact: Sergio G Susmallian, MDfirstname.lastname@example.org|
|Contact: Yfat Klain, Msemail@example.com|
|Assuta Medican Center||Not yet recruiting|
|Tel Aviv, Israel, 69710|
|Contact: Sergio G Susmallian, MD 972524637743 firstname.lastname@example.org|
|Contact: Yfat Klain, Mrs 972506764695 IfatGoldberg@hotmail.com|
|Study Director:||Sergio G Susmallian, MD||Assuta Medical Center|