Prehabilitation for Soft Tissue Sarcoma

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Superficial sarcomas, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercising before surgery aids recovery for patients with deep soft tissue sarcomas (a type of cancer in the soft tissues). Some participants will follow personalized exercise routines, known as an Individualized Prehabilitation Exercise Regimen, during their regular cancer treatment, while others will receive educational materials. The goal is to discover if pre-surgery exercises enhance recovery and quality of life post-surgery. Ideal candidates for this trial have confirmed deep soft tissue sarcoma in the lower limbs, without cancer spread or superficial sarcomas. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation exercise regimen is safe for patients with soft tissue sarcoma?

Research shows that exercising before surgery, known as prehabilitation, is generally safe and well-tolerated. Studies have found that these exercises usually don't cause serious side effects. They prepare the body for surgery, aiding recovery and improving overall health afterward.

For people with soft tissue sarcomas, prehabilitation exercises are customized to fit individual needs. These exercises strengthen the body before surgery. Feeling a bit sore or tired after exercising is normal, but these feelings are usually manageable. The main goal is to strengthen and prepare the body for surgery, leading to improved outcomes and a better quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of prehabilitation, a proactive exercise regimen, for patients with soft tissue sarcoma. Unlike the standard care that focuses solely on treating the cancer with surgery and radiotherapy, this approach involves personalized physical therapy exercises conducted before surgery. This method aims to improve patients' physical fitness and potentially enhance recovery and treatment outcomes. By integrating telemedicine and educational materials, patients receive comprehensive support, which may lead to better adherence and more favorable health results.

What evidence suggests that this prehabilitation exercise regimen is effective for soft tissue sarcoma recovery?

Research shows that exercising before surgery, known as prehabilitation, can help patients with deep soft tissue sarcomas recover better. In this trial, participants in Arm I will follow a personalized prehabilitation physical therapy exercise plan. Studies have found that such plans often lead to better surgery outcomes and quicker recovery. One review noted that these exercise programs can boost physical strength and improve quality of life for cancer patients. By preparing the body before surgery, patients might experience less disability and lower rates of depression afterward. Overall, prehabilitation could greatly enhance recovery and well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Krista A. Goulding, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of deep soft tissue sarcoma in the lower extremity, who can consent to participate. It's not for those with metastatic disease, tumors in superficial locations relative to fascia, or involvement of both upper and lower limbs.

Inclusion Criteria

Subjects must be able to provide appropriate consent or have an appropriate representative available to do so

My cancer is contained in one area.

My gender does not limit my participation.

Exclusion Criteria

My cancer has spread to distant parts of my body or to my lymph nodes.

Both my arms and legs are affected.

My sarcoma is located near the surface of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation and Radiotherapy

Participants perform personalized prehabilitation physical therapy exercises while receiving standard of care radiotherapy and prior to surgery

8 weeks

8 telemedicine visits (weekly)

Surgery

Participants undergo standard of care surgery for soft tissue sarcoma

1 week

Follow-up

Participants are monitored for safety and effectiveness after surgery

12 weeks

3 visits (in-person) at weeks 2, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Prehabilitation Exercise Regimen
• Physical Therapy

Trial Overview The study tests if a personalized exercise program (prehabilitation) during radiotherapy before surgery improves recovery and surgical outcomes for patients with soft tissue sarcomas compared to standard care without prehabilitation.

How Is the Trial Designed?

Group I: Arm I (prehabilitation physical therapy) Experimental Treatment 6 Interventions

Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.

Group II: Arm II (educational materials) Active Control 5 Interventions

Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Prehabilitation combining endurance and resistance training (CT) in cancer patients undergoing surgery showed no adverse effects and improved physical capacity, muscle strength, and some aspects of quality of life, based on a review of 10 studies involving 360 patients.

CT was associated with a shorter length of hospital stay and a reduction in postoperative pulmonary complications, indicating potential benefits for recovery after tumor resection surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of preoperative combined aerobic and resistance exercise training in cancer patients undergoing tumour resection surgery: A systematic review of randomised trials. Piraux, E., Caty, G., Reychler, G.[2019]

Cancer prehabilitation, which includes exercise, nutrition, education, psychological counseling, and smoking cessation, can enhance functional status and improve outcomes for patients undergoing cancer treatment.

Oncology nurses play a vital role in promoting prehabilitation by assessing patients' needs, advocating for these services, and educating survivors about their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role and Scope of Prehabilitation in Cancer Care. Lukez, A., Baima, J.[2021]

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

Lower-extremities sarcoma patients should begin supportive rehabilitation and low-intensity physical activity after surgery to improve their quality of life, with a gradual increase in intensity during recovery.

Moderate-intensity resistance and endurance exercises (30-60 minutes per day) are safe for these patients post-surgery, even when undergoing adjuvant chemotherapy or radiotherapy, and a general goal of 150 minutes of combined exercise per week is achievable after 18-24 months of rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Practice of Physical Activity in the Setting of Lower-Extremities Sarcomas: A First Step toward Clinical Optimization. Assi, M., Ropars, M., Rébillard, A.[2020]

Home-based prehabilitation (HBP) significantly improves postoperative functional capacity in cancer patients, as shown by a meta-analysis of five trials involving 351 patients, with notable improvements in the 6-minute walk test both preoperatively and eight weeks postoperatively.

Compliance rates for HBP ranged from 63% to 83%, indicating that patients generally adhered to the program, and suggesting that HBP could be a viable alternative to traditional hospital-based prehabilitation, especially during times of social distancing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit4Surgery for cancer patients during covid-19 lockdown - A systematic review and meta-analysis. van Gestel, T., Groen, LCB., Puik, JR., et al.[2022]

A feasibility study involving 8 frail patients with colorectal cancer showed that a multimodal prehabilitation program, including high-intensity interval training and nutritional support, can be successfully implemented before surgery, with 87% adherence to training sessions.

Despite challenges in measuring compliance with high-intensity training, the study indicates that this approach is manageable for elderly patients, suggesting potential benefits for improving surgical outcomes in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Bojesen, RD., Jørgensen, LB., Grube, C., et al.[2022]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A pilot study involving 22 patients showed that a smartwatch-delivered prehabilitation program significantly increased daily physical activity and improved functional fitness, as measured by the 6-minute walk test, compared to a control group.

The prehabilitation group demonstrated a notable improvement in walking distance (+85.6 m) compared to the control group (+13.23 m), suggesting that technology-assisted prehabilitation can enhance pre-operative fitness in patients undergoing major abdominal cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). Waller, E., Sutton, P., Rahman, S., et al.[2022]

Surgical prehabilitation can enhance patients' ability to handle surgery stress, lower the risk of complications, and speed up recovery, particularly for cancer patients.

Resistance training is highlighted as a crucial part of prehabilitation, with specific guidelines on exercise design and patient progression to improve its effectiveness and implementation in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: Key Aspects of Multimodal Prehabilitation in Surgical Patients With Cancer. A Practical Approach to Integrating Resistance Exercise Programmes. Laza-Cagigas, R., Seijo, M., Swaine, I., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05583

Individualized Prehabilitation for Enhancing Recovery and ... This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11718807/

A Narrative Review of the Assessment and Treatment ... This review article aims to examine the physical impairments commonly seen in patients living with sarcoma during and after cancer therapy and their treatment

3. clinconnect.io clinconnect.io/trials/NCT05526417

Individualized Prehabilitation for Enhancing Recovery This clinical trial is looking at how a personalized exercise program, called prehabilitation, can help patients with deep soft tissue sarcomas recover better ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03916796

Rehabilitation and Quality of Life Assessment for Soft ... This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and ...

5. trial.medpath.com trial.medpath.com/clinical-trial/8f8863a9f514407b/nct06743958-prehabilitative-training-sarcoma-children

Prehabilitation in Childhood Soft Tissue or Bone Sarcomas This study aims to investigate the feasibility of a prehabilitative training intervention. The intervention includes specific strength and balance exercises ...

6. mayoclinic.org mayoclinic.org/medical-professionals/orthopedic-surgery/news/mayo-clinic-led-study-open-for-enrollment-prehabilitation-for-patients-receiving-radiotherapy-and-surgery-for-soft-tissue-sarcoma/mac-20585833

Prehabilitation for patients receiving radiotherapy and ... Mayo Clinic-led study open for enrollment: Prehabilitation for patients receiving radiotherapy and surgery for soft tissue sarcoma. July 22, ...

7. ctv.veeva.com ctv.veeva.com/study/prehabilitation-to-improve-cancer-surgery-outcomes-in-aya-patients-with-extremity-sarcomas

Prehabilitation to Improve Cancer Surgery Outcomes in AYA ... The purpose of this study was to evaluate the feasibility of a multimodal prehabilitation intervention intended to optimize postoperative ...