Bacterial Decolonization for Soft Tissue Sarcoma

(CONCERTO Trial)

Overseen By Samantha Demko, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Adam Olson

Disqualifiers: Allergy to mupirocin, chlorhexidine, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.

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 drug Chlorhexidine Gluconate Body Cleanser and Intranasal Mupirocin Ointment for bacterial decolonization in soft tissue sarcoma patients?

Research shows that using mupirocin and chlorhexidine can help reduce infections caused by Staphylococcus aureus, a common bacteria, especially in hospital settings. These drugs have been effective in reducing bacterial presence in the nose and on the skin, which can lower the risk of infections after surgery. ^{1 2 3 4 5}

Is the combination of Chlorhexidine Gluconate and Mupirocin safe for human use?

Studies have shown that using Chlorhexidine Gluconate body wash and Mupirocin ointment is generally safe for humans, with low levels of resistance in bacteria. However, some people may still carry resistant strains, which can affect the success of treatment. ^{1 3 4 6 7}

How does the drug for bacterial decolonization differ from other treatments for soft tissue sarcoma?

The drug for bacterial decolonization, involving mupirocin and chlorhexidine, is unique because it targets the removal of bacteria like MRSA (a type of bacteria resistant to many antibiotics) from the body, which can help prevent infections after surgery. This approach is different from typical cancer treatments, which focus on directly targeting cancer cells rather than preventing bacterial infections. ^{2 3 4 5 8}

Research Team

Adam Olson

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

This trial is for individuals with soft tissue sarcoma in the lower extremity. Participants should be preparing to receive preoperative radiotherapy and must follow a specific cleansing routine before and during treatment.

Inclusion Criteria

Negative serum pregnancy test for women of childbearing potential < 28 days prior to RT

Informed consent signed and dated to participate in the study

I am willing and able to follow study requirements.

Exclusion Criteria

Allergy to mupirocin and/or chlorhexidine

I have a skin condition in the area being treated with radiation.

I have had radiation therapy in the same area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bacterial Decolonization

Participants undergo bacterial decolonization with intranasal mupirocin ointment and chlorhexidine body cleanser for 5 days prior to radiation therapy and repeated every 2 weeks during radiation therapy

5 days prior to RT and repeated every 2 weeks during RT

Radiation Therapy

Participants receive preoperative radiation therapy with one of three dose/fractionation regimens

Varies based on regimen (e.g., 50 Gy in 25 fractions)

Surgery

Index surgery is performed with the use of indocyanine green angiography at the time of wound closure

At the end of radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound complications and survival outcomes

Up to 24 months

Treatment Details

Interventions

• Chlorhexidine Gluconate Body Cleanser
• Intranasal Mupirocin Ointment

Trial Overview The study tests if using mupirocin ointment in the nose and chlorhexidine body cleanser can reduce wound complications from radiation therapy. It also examines how effective ICG angiography is at wound closure time.

Participant Groups

Group I: BD + Intranasal Mupirocin + Chlorhexidine Experimental Treatment 2 Interventions

Bacterial Decolonization with 2% intranasal mupirocin ointment twice daily (BID) and 4% chlorhexidine gluconate body cleanser, once daily (QD) for 5 consecutive days prior to RT, and this will be repeated for 5 days every 2 weeks throughout Radiation Therapy. The treatment will also be administered for 5 consecutive days prior to index surgery. RT can be prescribed in one of three dose/fractionation regimens at the investigator's discretion: 50 Gy in 25 fractions, 42.75 Gy in 15 fractions, or 36 Gy in 18 fractions

Who Is Running the Clinical Trial?

Adam Olson

Lead Sponsor

Trials

2

Recruited

190+

Pittsburgh Cure Sarcoma

Collaborator

Trials

1

Recruited

30+

References

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

Methicillin-Resistant Staphylococcus aureus in a Trauma Population: Does Decolonization Prevent Infection? [2018]

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

Mupirocin susceptibility of staphylococci 2022: Is it time for a change in MRSA decolonization protocols? [2023]

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

Mupirocin and chlorhexidine resistance in Staphylococcus aureus in patients with community-onset skin and soft tissue infections. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Decolonisation of MRSA and its effect on surgical site infections--a study in a tertiary care institute. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Overview of the role of mupirocin. [2019]

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

Microbiological effect of mupirocin and chlorhexidine for Staphylococcus aureus decolonization in community and nursing home based adults. [2021]

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

Elimination of coincident Staphylococcus aureus nasal and hand carriage with intranasal application of mupirocin calcium ointment. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis. [2022]