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

NCT03389204 | Completed

• 1 other identifier: AMC2020-17
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast surgery; Physiotherapy; Breast Cancer; Shoulder pain; Shoulder motion

Outcome Measures

Primary Outcomes (1)

• Shoulder pain

  The intensity of pain and chronological modification will be monitored

  6 mnth

Other Outcomes (4)

• Function of upper limb

  six month

• Complications

  six month

• Lymph edema

  6 mnth

Study Arms (4)

Breast surgery and exercise

ACTIVE COMPARATOR

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

Other: PHYSICAL THERAPY

Breast surgery and no exercise

ACTIVE COMPARATOR

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

Other: PHYSICAL THERAPY

Breast, axilar surgery with exercise

ACTIVE COMPARATOR

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

Breast, axillar surgery without exercise

ACTIVE COMPARATOR

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

Other: PHYSICAL THERAPY

Interventions

PHYSICAL THERAPY OTHER

EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT

Breast surgery and exercise; Breast surgery and no exercise; Breast, axilar surgery with exercise; Breast, axillar surgery without exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

Assuta Medican Center

Tel Aviv, 69710, Israel

Location

Related Publications (1)

• 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.

  PMID: 34800988 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Shoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sergio G Susmallian, MD

  Assuta Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to physical support or not
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of General Surgery

Model Details: RCT intervention and not intervention

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 3, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: February 01 2019
• Access Criteria: Physiotherapy after breast cancer surgery

Locations

IL (1)