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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a nasal ointment and body cleanser can reduce the risk of wound problems after surgery and radiation for individuals with soft tissue sarcoma in the leg. The treatments include mupirocin ointment for the nose (an antibiotic ointment) and chlorhexidine body wash (an antiseptic cleanser), used before and during radiation therapy. The goal is to determine if these affordable and safe treatments can prevent skin issues from radiation and improve surgery outcomes. This trial may suit someone recently diagnosed with soft tissue sarcoma in the lower leg who plans to undergo surgery and radiation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both chlorhexidine gluconate body wash and intranasal mupirocin ointment are generally safe for patients. Chlorhexidine effectively cleans the skin before surgery and is not more harmful than regular soap. Serious side effects are rare, though some individuals might experience mild skin irritation.

Intranasal mupirocin ointment reduces nasal bacteria and lowers the risk of post-surgery infections. Studies have found it safe for both children and adults, with mild side effects such as nasal irritation.

These treatments are in a Phase 2 trial for soft tissue sarcoma, indicating they have passed initial safety tests and are likely safe for humans. However, it is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Chlorhexidine Gluconate Body Cleanser and Intranasal Mupirocin Ointment for bacterial decolonization in soft tissue sarcoma because these treatments target harmful bacteria on the skin and in the nasal passages, potentially reducing infection risks during cancer treatment. Unlike traditional antibiotics that are taken orally or intravenously, this approach uses a topical cleanser and nasal ointment, which focuses on eliminating bacteria where they commonly reside. This method could minimize the likelihood of infections during radiation therapy and surgery, potentially improving patient outcomes by lowering complication rates.

What evidence suggests that this trial's treatments could be effective for reducing wound complications in soft tissue sarcoma?

In this trial, participants will receive a combination of treatments, including a special body wash called chlorhexidine gluconate and a nose ointment called mupirocin. Research has shown that chlorhexidine gluconate reduces bacteria on the skin, lowering infection risk. Studies have found that using both chlorhexidine and mupirocin together can cut the risk of infection by 30% after hospital discharge. Mupirocin effectively reduces bacteria in the nose, decreasing the chance of infections at surgical sites. These treatments aim to reduce infection risks, which is especially important for people receiving radiation therapy for soft tissue sarcoma. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam Olson

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7447168/

Chlorhexidine Bathing Strategies for Multidrug-Resistant ... Chlorhexidine bathing is effective at reducing acquisition and decolonization, particularly by MDR gram-positive bacteria.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831186

Universal vs Targeted Chlorhexidine Bathing and Nasal ... The findings of this study suggest that, in most general inpatient units, chlorhexidine bathing and nasal decolonization may be a cost-effective way to reduce ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1716771

Decolonization to Reduce Postdischarge Infection Risk ... Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection than education alone.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12286417/

Chlorhexidine gluconate skin levels and organism ... Bathing with the antiseptic chlorhexidine gluconate (CHG) is increasingly being used to reduce bioburden on patient skin to help lower the risk of colonization ...

5. archive.hshsl.umaryland.edu archive.hshsl.umaryland.edu/bitstreams/dabb0841-0490-468c-ad2b-27857f106770/download

DECOLONIZATION USING CHLORHEXIDINE GLUCONATE Efficacy evaluation of a 4% chlorhexidine gluconate as a full-body shower wash. American Journal Of Infection Control, 21(4), 205-209. Paulson, D. (2003) ...

6. clinicaltrials.gov clinicaltrials.gov/search?cond=%22Soft%20Tissue%20Sarcoma%22&intr=%22chlorhexidine%20gluconate%22&viewType=Table&rank=1

Search for: "Soft Tissue Sarcoma", "chlorhexidine gluconate" An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK536431/

Global Guidelines for the Prevention of Surgical Site Infection Moderate quality evidence shows that preoperative bathing with antimicrobial soap containing CHG has neither benefit nor harm compared to plain soap in reducing ...

8. academic.oup.com academic.oup.com/bjsopen/article/6/5/zrac111/6704885

Efficacy of surgical skin preparation with chlorhexidine in ... The present meta-analysis demonstrated that CHG was more protective than PVP-I in the evaluation limited to alcohol-based solution. Skin ...

9. cdn.who.int cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/evidence/appendix2.pdf?sfvrsn=9cbd2ef9_2

WHO Surgical Site Infection Prevention Guidelines Current evidence suggests that CHG may not have a significant benefit or harm compared to plain soap in preventing SSI. Cost and availability may also pose a ...

10. scholarlycommons.hcahealthcare.com scholarlycommons.hcahealthcare.com/cgi/viewcontent.cgi?article=1997&context=hcahealthcarejournal

A Randomized Controlled Trial of 2% Chlorhexidine ... The purpose of this randomized controlled trial was to compare SSI rates and overall skin flora burden between those using chlorhexidine (CHG) cloths versus ...