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Prehabilitation and Enhanced Recovery After Surgery to Improve Acute Wound Healing Complications in Soft Tissue Sarcoma Treated With Neoadjuvant Radiotherapy

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ClinicalTrials.gov Identifier: NCT03916796
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
ReVital Cancer Rehabilitation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

This study is designed as a lead-in adherence study evaluating feasibility followed by full pilot evaluating the prehabiliation and ERAS protocols. This study will first assess a 5-patient lead-in cohort to determine if patients adequately adhere to the prehabilitation protocol. If successful, the study will proceed with a full pilot of the multimodal prehabiliation protocol.

Prehabilitation is not well studied in the STS population. As such, a secondary goal of this study will be to determine the effects of the multi-modal prehabilitation and ERAS protocols on physical function and quality of life outcomes.


Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Other: Exercise Other: Enhanced Recovery after surgery Other: Psychological screening with counselling services as needed Other: Dietary Counseling Services Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prehabilitation and Enhanced Recovery After Surgery to Improve Acute Wound Healing Complications in Soft Tissue Sarcoma Treated With Neoadjuvant Radiotherapy
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary Counseling/Exercise/ERAS/Psychological Counsel
  • Patients must be treated using daily image-guided radiotherapy
  • Dietary counseling at baseline
  • Exercise intervention at baseline, physical therapy visits during radiotherapy & during the post-radiotherapy period until the week of surgery
  • Enhanced recovery after surgery (ERAS) - patients with extremity and trunk STC will be treated with the hip/knee protocol and patients with abdominal/retroperitoneal STS will be treated with the hepatobiliary protocol
  • Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling
Other: Exercise
-The exercise part will consist of an evaluation and treatment as prescribed by a physical therapist including aerobic & dynamic stretching warm-up, strength training, balance training, and flexibility training. Will also include a home exercise program (HEP). Physical therapists will have specialized training in cancer rehabilitation obtained through the ReVital certification process.

Other: Enhanced Recovery after surgery
-The protocols include instructions for patient care from the time of pre-surgical admission to discharge, including directives regarding diet, labs, IV fluids, pain management, prophylactic medications, management of indwelling catheters and drains, and activity.
Other Name: ERAS

Other: Psychological screening with counselling services as needed
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit

Other: Dietary Counseling Services
-Patients will have a baseline nutrition counseling visit with a Registered Dietician. This may include a nutrition assessment and nutrition counseling to set priorities, establish goals, and create an individualized plan




Primary Outcome Measures :
  1. Percentage of prescribed dietary and physical therapy visits completed during the prehabilitation period [ Time Frame: Within 90 days following surgery ]
    -This will be quantified as the proportion of prescribed visits within the prehabilitation protocol that are attended by the patient. If a patient participates in any portion of a prescribed visit, it will be counted as attended.


Secondary Outcome Measures :
  1. Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy [ Time Frame: From baseline through 90 days after surgery ]
  2. Quality of life as measured by the PROMIS Global total score [ Time Frame: Change from baseline through 90 day follow-up ]
    -PROMIS scales to be used: Physical Function-10, Ability to Participate in Social Roles, Pain Interference, Anxiety and Depression, and Activities-4 and Global Health assessments. These are validated instruments with items ranked on a 5-point Likert scale. PROMIS is scored using T scores, which are standardized to the U.S. general population and have a mean of 50 and a standard deviation of 10. Scores above or below 50 are above or below the population average in the U.S. general population, respectively. The total T score will be calculated for this outcome measure

  3. Quality of life as measured by the TESS [ Time Frame: Change from baseline through 90 day follow-up ]
    -The Toronto Extremity Salvage Score was developed as a measure of patient reported physical functioning for patients undergoing limb salvage surgery for bone and STS

  4. Patient cardiovascular capacity as measured by the 6-minute walk test [ Time Frame: Change from baseline through 90 day follow-up ]
    -This test measures number of meters participants are able to walk in a level setting.

  5. Patient general physical health status as measured by 30-second sit to stand test [ Time Frame: Change from baseline through 90 day follow-up ]
    -The 30 second chair stand test is used to measure functional lower extremity strength and overall endurance. Participants are asked to go from a sitting position to standing from a chair as many times as they can within 30 seconds. Higher numbers of sit to stand correlate with increased physical function and lower body strength

  6. Patient fall risk as measured by Timed Up and Go test [ Time Frame: Change from baseline through 90 day follow-up ]
    -The Timed Up and Go is a performance test of physical mobility and fall risk. The TUG measures how long it takes the patient, in seconds, to stand up from a standard arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down again. Scores of 11 or below are predictive of fall risk

  7. Patient general physical health status as measured hand grip strength [ Time Frame: Change from baseline through 90 day follow-up ]
    -Hand grip strength is measured with the Jamar hydraulic handgrip dynamometer. Measurement is completed with participant in seated position, holding arm at side, elbow at 90 degrees, and with dynamometer at either second or third position (based on size of hands, smaller hands position 2, larger hands position 3) and participants are encouraged to squeeze as much as possible, 3 times with a minute in between each trial. Number of pounds strength is recorded along with hand dominance. This measure is used to record upper body strength

  8. Quality of life as measured by the Work Ability Index [ Time Frame: Change from baseline through 90 day follow-up ]
    -This patient-reported outcome measure asks ability to work on a scale of 0-10 with 0 being unable, and 10 fully able. It follows with two items asking about reduction in physical and mental work ability due to cancer and its treatment. Lastly, it asks how many days the participant has been off work. For this assessment higher scores indicate better levels of work ability

  9. Quality of life as measured by the history of previous falls [ Time Frame: Change from baseline through 90 day follow-up ]
    -Asking patients to report the number of times they've fallen in the last 6 months. Patients who respond they have fallen in the past is correlated to risk of treatment toxicity and risk of future falls

  10. Acute wound complication rate [ Time Frame: Within first 90 days following surgery ]
    -Wound complications include secondary procedures, deep wound packing, readmission to the hospital, wet dressings >4 weeks, or extended dressings >6 weeks.



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest)
  • Planning to receive neoadjuvant radiotherapy to a dose of 50-50.4 Gy delivered over 5 weeks followed by planned surgical resection.
  • At least 16 years of age.
  • ECOG performance status ≤ 3
  • Able to complete the prehabilitation protocol safely, as determined by a treating physician.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon.
  • Patients with deep retroperitoneal or abdominal STS
  • Patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy.
  • Currently receiving any investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy.
  • HIV-positive patients whose CD4+ T-cell count is < 350 cells/mcL.
  • Receiving concurrent chemoradiation therapy

Information from the National Library of Medicine

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): NCT03916796


Contacts
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Contact: Matthew Spraker, M.D., Ph.D. 314-362-8567 mspraker@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Matthew Spraker, M.D., Ph.D.    314-362-8567    mspraker@wustl.edu   
Principal Investigator: Matthew Spraker, M.D., Ph.D.         
Sub-Investigator: Brian Van Tine, M.D.         
Sub-Investigator: Angela Hirbe, M.D.         
Sub-Investigator: Peter Oppelt, M.D.         
Sub-Investigator: Brian Baumann, M.D.         
Sub-Investigator: Jeff Michalski, M.D.         
Sub-Investigator: Leping Wan, MPH         
Sub-Investigator: Cara Cipriano, M.D.         
Sub-Investigator: Douglas McDonald, M.D.         
Sub-Investigator: Regis O'Keefe, M.D.         
Sub-Investigator: Nate Olafsen, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
ReVital Cancer Rehabilitation
Investigators
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Principal Investigator: Matthew Spraker, M.D., Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03916796    
Other Study ID Numbers: 201904042
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms