Clinical trial NCT03389204: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast surgery
Physiotherapy
Breast Cancer
Shoulder pain
Shoulder motion
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT intervention and not intervention
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Shoulder pain
timeFrame: 6 mnth
Secondary outcomes:
Other outcomes:
measure: Function of upper limb
timeFrame: six month
measure: Complications
timeFrame: six month
measure: Lymph edema
timeFrame: 6 mnth
measure: physical activities influence in recovery after breast cancer surgery
timeFrame: 6 mnth
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medican Center
Study officials:
affiliation: Assuta Medical Center
name: Sergio G Susmallian, MD
role: STUDY_DIRECTOR
References:
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.