Clinical trial NCT03916796: Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Official title: Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Soft Tissue Sarcoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: ReVital Cancer Rehabilitation
First posted: 2019-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest)
* Planning to receive radiotherapy and surgical resection
* At least 16 years of age.
* ECOG performance status ≤ 3
* Able to complete the cancer rehabilitation 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

Primary outcomes:
measure: Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
timeFrame: Through 3 month follow-up
Secondary outcomes:
measure: Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
timeFrame: From baseline through 24 month follow-up
measure: Quality of life as measured by the PROMIS Global total score
timeFrame: Change from baseline through 24 month follow-up
measure: Quality of life as measured by the TESS
timeFrame: Change from baseline through 24 month follow-up
measure: Patient cardiovascular capacity as measured by the 6-minute walk test
timeFrame: Change from baseline through 3 month follow-up
measure: Patient general physical health status as measured by 30-second sit to stand test
timeFrame: Change from baseline through 3 month follow-up
measure: Patient fall risk as measured by Timed Up and Go test
timeFrame: Change from baseline through 3 month follow-up
measure: Patient general physical health status as measured hand grip strength
timeFrame: Change from baseline through 3 month follow-up
measure: Quality of life as measured by the Work Ability Index
timeFrame: Change from baseline through 24 month follow-up
measure: Quality of life as measured by the history of previous falls
timeFrame: Change from baseline through 24 month follow-up
measure: Acute wound complication rate
timeFrame: Within first 90 days following surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Matthew Spraker, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: