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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.

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 data supports the effectiveness of the treatment Individualized Prehabilitation Exercise Regimen for soft tissue sarcoma?

Prehabilitation, which includes exercise programs, has shown promise in improving recovery after major surgeries, such as abdominal cancer surgery. While specific data for soft tissue sarcoma is limited, similar approaches in other cancers suggest that tailored exercise regimens can enhance physical fitness and potentially improve post-surgery outcomes. ^{1 2 3 4 5}

Is prehabilitation exercise safe for humans?

Prehabilitation exercise programs, which include moderate-intensity resistance and endurance exercises, are generally considered safe for cancer patients, even after surgery and during chemotherapy or radiotherapy. These programs aim to improve physical fitness and quality of life, and they are designed to be low-risk when tailored to individual needs. ^{1 2 5 6 7}

How is the Prehabilitation Exercise Program different from other treatments for soft tissue sarcoma?

The Prehabilitation Exercise Program is unique because it focuses on preparing patients physically before surgery to improve their recovery and reduce complications, unlike traditional treatments that focus on post-surgery care. It includes personalized exercise regimens, particularly resistance training, to enhance patients' strength and endurance before undergoing cancer surgery. ^{2 5 7 8 9}

Research Team

Krista A. Goulding, MD, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am 18 years old or older.

My cancer is contained in one area.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. [2022]

3. England 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. [2022]

4. Germany 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). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Commentary: Key Aspects of Multimodal Prehabilitation in Surgical Patients With Cancer. A Practical Approach to Integrating Resistance Exercise Programmes. [2023]

6. Netherlands 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Role and Scope of Prehabilitation in Cancer Care. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Fit4Surgery for cancer patients during covid-19 lockdown - A systematic review and meta-analysis. [2022]