Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)

NCT ID: NCT04225572

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2025-12-12

Brief Summary

Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patient will not receive physical therapy treatment or further instruction from the research team. The patient will receive standard care recommended by their medical provider which may or may not include physical therapy treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical Therapy Group

Group Type: EXPERIMENTAL

Physical Therapy: Dependent on Patient's Needs

Intervention Type: BEHAVIORAL

Therapeutic exercise:

• ROM: Begin with passive upper extremity ROM and progress to active ROM.
• Strengthening: Progressive upper extremity resistive exercises starting with light weights.
• Aerobic: Select a suitable, individual aerobic exercise program (walking, yoga, etc.) Manual therapy
• Soft tissue mobilization, myofascial release, and stretching of identified tight and stiff tissue.

Lymphedema treatment

• Manual lymph drainage: Gentle lymphatic massage to lymph nodes and vessels by PT for 1-2 weeks. Instruct patient in self MLD to perform 1-2×/day for 10 minutes during the remaining weeks.
• Compression therapy: Gradient compression bandaging for daily wear with activities and exercise for 1-2 weeks. Instruct in self compression bandaging or issue a compression garment to wear with exercise or activity, or with worsening symptoms of AWS (i.e. cording extends down arm) or lymphedema.

Interventions

Physical Therapy: Dependent on Patient's Needs

Therapeutic exercise:

• ROM: Begin with passive upper extremity ROM and progress to active ROM.
• Strengthening: Progressive upper extremity resistive exercises starting with light weights.
• Aerobic: Select a suitable, individual aerobic exercise program (walking, yoga, etc.) Manual therapy
• Soft tissue mobilization, myofascial release, and stretching of identified tight and stiff tissue.

Lymphedema treatment

• Manual lymph drainage: Gentle lymphatic massage to lymph nodes and vessels by PT for 1-2 weeks. Instruct patient in self MLD to perform 1-2×/day for 10 minutes during the remaining weeks.
• Compression therapy: Gradient compression bandaging for daily wear with activities and exercise for 1-2 weeks. Instruct in self compression bandaging or issue a compression garment to wear with exercise or activity, or with worsening symptoms of AWS (i.e. cording extends down arm) or lymphedema.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18
• Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer
• Planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. Contralateral prophylactic mastectomy or bilateral mastectomy is allowed.
• Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

Exclusion Criteria

• Patients (patients unable to travel easily to the University of Minnesota Medical Center for post-surgery visits).
• Synchronous bilateral breast cancer
• Presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer
• Previous history of upper extremity deep vein thrombosis
• Breast cancer surgery without lymph node removal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Koehler, PhD, PT, CLT-LANA

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, Division of Physical Therapy

Locations

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PMR-2017-26231

Identifier Type: OTHER

Identifier Source: secondary_id

2017NTLS119

Identifier Type: -

Identifier Source: org_study_id