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

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT04225572

Collaborator

(none)

200

Enrollment

Location

Arms

69.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Physical Therapy: Dependent on Patient's Needs	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 2, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: Physical Therapy Group	Behavioral: 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.

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: Physical Therapy Group

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Clinical characteristics of preoperative Auxillary Web Syndrome (AWS) [1 Year]
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Treatment Effects [1 Year]
Range of motion (ROM) will be measured using a standard goniometer

Secondary Outcome Measures

Pain level [1 Year]
Measured by 0-10 scale and Penn Shoulder Score questionaire
Function [1 Year]
Disabilities of the Arm, Shoulder and Hand questionaire
Lymphedema [1 Year]
Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy
Physical activity [1 Year]
Measured by International Physical Activity Questionaire IPAQ (short form)
Axillary web syndrome status [1 Year]
(present/not present) based on palpable assessment by investigator
Preoperative AWS and a positive lymph node status [1 Year]
Correlation between AWS and a positive lymph node status
Abduction range of motion (ROM) [1 month]
ROM measured by a standard goniometer
DASH Score [1 Month]
Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire
Body mass index (BMI) [1 month]
Difference in body mass index (BMI) between patients with and without AWS (pre and post operative)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator: Linda Koehler, PhD, PT, CLT-LANA, University of Minnesota, Division of Physical Therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT04225572

Other Study ID Numbers:

2017NTLS119
PMR-2017-26231

First Posted:

Jan 13, 2020

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 21, 2022