Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Paronychia

Exanthema

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Dermatologic Agents

Antineoplastic Agents

Chlorhexidine

Doxycycline

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Chlorhexidine gluconate

Mitogens

Minocycline

Lazertinib

Amivantamab-vmjw

Anti-Infective Agents, Local

Disinfectants

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

Participants will receive enhanced dermatologic management to reduce dermatologic toxicities in skin and nail with oral doxycycline tablet or minocycline capsule (100 milligrams \[mg\] twice daily for 12 weeks), clindamycin 1 percent (%) topical lotion, chlorhexidine 4% topical solution, and noncomedogenic skin moisturizer (once daily, sufficient quantity to cover skin) during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab (1050 mg for body weight less than \[\<\] 80 kilograms \[kg\] and 1400 mg for body weight greater than or equal to \[\>=\] 80 kg as intravenous \[IV\] infusion, once weekly for the first 4 weeks and then once every 2 weeks) and lazertinib (240 mg, tablet, once daily) until documented disease progression using Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1).

Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab plus lazertinib.

Amivantamab will be administered as intravenous (IV) infusion.

Amivantamab

Lazertinib tablet will be administered orally.

Doxycycline tablet will be administered orally.

Minocycline capsule will be administered orally.

Clindamycin lotion will be used as topical application on the scalp.

Chlorhexidine solution will be used as topical application on hands and feet.

Noncomedogenic skin moisturizer will be used as topical application.

Noncomedogenic skin moisturizer

Study Contact

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib.

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Number of participants with Grade \>= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

Number of participants with DAEIs by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with Grade \>=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI CTCAE v 5.0 will be reported.

Time to first occurrence of Grade \>=2 DAEI will be reported.

Number of participants with paronychia by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with scalp rash by severity based on NCI CTCAE v 5.0 will be reported.

Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions.

Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale.

Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported.

Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose.

Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Percentage of participants with AEs by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first.

ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator.

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria.

Janssen Research & Development, LLC

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Communicable Diseases

Surgical Wound Infection

Wound Infection

Disease Attributes

Breast Diseases

Skin Diseases

Central Nervous System Depressants

Blood Substitutes

Micronutrients

Ethanol

Povidone-Iodine

Povidone

Iodine

Cadexomer iodine

Plasma Substitutes

Preoperative skin preparation with chlorhexidine 2% in alcohol 70% solution

Preoperative skin preparation with povidone-iodine 10% solution

Preoperative skin preparation with tinted chlorhexidine gluconate 2% in 70% isopropyl alcohol administered with single-dose applicator

Preoperative skin preparation with povidone-iodine 10% aqueous solution

Martin Langer, Prof

The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site, since the patient's skin is the principal source of bacterial contamination of the wound. This study aims to investigate the efficacy in prevention of surgical site infection in clean surgery, using two different standardized methods of skin preparation: povidone-iodine 10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a single-center study will enroll a homogeneous population, undergoing breast cancer surgery.

The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site, since the patient's skin is the principal source of bacterial contamination of the wound. Products generally used for preoperative preparation of the skin are iodophores (povidone-iodine), and products containing alcohol and/or chlorhexidine.

To date, in the literature there are quite a number of case studies, but only few randomized controlled trials (RCTs) that compare different methods of preparation of the skin at the site of surgery. Only recently a major study comparing between 2 modes of skin preparation before surgery has been performed and published, and at least 2 systematic reviews of various methods can be found. At present, the use of chlorhexidine in alcohol is seen to be more effective than povidone-iodine in the prevention of surgical site infection, but the data derived from the available studies are not sufficient to definitely support a change in the daily practice, and quantitative evaluation of pharmaco-economics implications are still missing.

This study aims to investigate the efficacy in prevention of surgical site infection in clean surgery, using two different standardized methods of skin preparation: povidone-iodine 10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a single-center study will enroll a homogeneous population, undergoing breast cancer surgery.

The patients included in this study will be randomized according to the week in which they will receive surgical treatment. The investigators expect this approach to be easier to manage within this study. The randomly assigned treatment will be weekly communicated to the chief nurse of the operating theatre who will supply the proper disinfectant without any other role in the study.

All patients will be scheduled for at least one follow up visit after about 2 weeks after surgery. All patients have access to more follow up visits, if needed, and will be asked to report all kind of wound complications.

The wound assessment will be made by persons not aware of the treatment arm the patient was assigned to, and a defined protocol assessment, based on Centers for Disease Control and prevention (CDC) definitions, which provides the following classification:

1. absence of infection;
2. superficial wound infection;
3. deep wound infection. The final follow-up visit during which the patient will be evaluated will be conducted at 30 days (for patients without insertion of prosthesis / expander) and at 180 days (for patients with the insertion of implants / expander).

Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine

A Randomized, Blinded, Single Center Study to Assess the Incidence of Surgical Site Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine 2% in Alcohol 70% (CHLORAPREP ®) Versus 10% Povidone-iodine

Cost-effective analysis if one treatment proves significantly superior to the other

Overall incidence of surgical site infections after surgery

Overall incidence of surgical site infections after surgery without implant

Overall incidence of surgical site infections after surgery with implant

Multivariate analysis of risk factors: presence or absence of implant, previous chemotherapy treatment, previous radiotherapy treatment, American Society Association class \> 2, length of surgery \> 2 hours, body mass index \> 35, diabetes mellitus

Record of number of additional hospital admission due to wound infection; Length of hospital stay; Need for additional surgery due to wound infection;Days of additional antibiotic therapy due to wound infection

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Mouth and Tooth Diseases

Rare Diseases

Dental Caries

Head and Neck Neoplasms

Mouth Neoplasms

Oral Cancer

Following 2 x 5-minute applications of 2.5 ml in clinic, 2 x 5.0 ml syringes of 1% chlorhexidine gluconate gel, self-administered for a 5-minute application Week 2 \& Week 4

Following two 2.5 ml 5-minute applications performed in clinic on Day 1, 2 x 5.0 ml syringes of chlorhexidine gel self-administered for one 5-minute application using the custom-made carriers carriers on week 2 (12-14 days from baseline visit study drug administration) and week 4 (12-14 days from Week 2 study drug administration).

1% Chlorhexidine Gluconate Gel

M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire, in addition to a 2nd subjective, study-specific questionnaire administered during visit taking about 5 minutes to complete each assessment.

Surveys

Rhonda F. Jacob, MS, BS, DDS

The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable to patients will also be studied.

1% chlorhexidine gluconate gel is an alcohol-free, raspberry-flavored brush-on gel. It is designed to decrease the amount of bacteria found in your mouth that can cause tooth decay.

Within a month, if you are found to be eligible to take part in this study, researchers will use custom dental trays designed for you, in order to deliver the chlorhexidine gel. During your next visit to the dental clinic, researchers will place these custom dental trays and the gel in your mouth for about 5 minutes. Over the next 30 minutes, the gel will be applied one more time. The dentist will also chart your decayed, missing, and filled teeth in a dentist chart during this visit. The dentist will also check the soft tissues of your mouth. You will have an office visit the next day (Day 2) to see if you had any side effects to the chlorhexidine gel.

These trays will be coated with the gel every 2 weeks, for a 12-week period. You will hold the trays with the gel in your mouth for at least 5 minutes, usually at night or in the morning. You should not eat or drink during these 5 minutes in order to increase the effectiveness of the gel on your teeth. You will apply the gel at home, for one 5-minute application, on Weeks 2, 4, 8 and 10. You will be given a diary to list each time that you use the gel at home, and to list if you experience any side effects. You will have office visits on Weeks 6 and 12. The dentist will floss between all of your teeth during these office visits. You will also use the gel, for two 5-minute applications, during these office visits. You will also need to bring the completed diary to each office visit.

When you return for the office visit, a dentist or dental hygienist will then collect a sample of your dental plaque (a film of mucous and bacteria found on your teeth's surface) by scraping plaque from the surface of your teeth and flossing between your teeth, and then placing the plaque in a small test tube to check for bacteria. The dentist will not scrape below the gums. These plaque samples will be collected on Weeks 6 and 12 at the dental clinic.

Once the gel application period is over, you will need to return to the dental clinic for plaque sample scrapings at Weeks 16 and 20 so that researchers can check to see if the bacteria is growing again.

You will also complete two questionnaires during your baseline, Week 6, and Week 12 visits to describe your experience with the use of the gel and your side effects from radiation treatment.

Once your last plaque sample scraping has been collected on Week 20, your participation in this study will be complete. The dentist or dental hygienist will floss between all of your teeth and your decayed, missing, and filled teeth will be charted in a dentist chart during the Week 20 office visit. You will be taken off study if intolerable side effects occur.

This is an investigational study. 1% chlorhexidine gluconate is not FDA approved or commercially available. It has been authorized for use in research only. About 50 patients will take part in this study. All will be enrolled at MD Anderson.

Chlorhexidine Gel Therapy for Cariogenic Oral Microflora

Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients

At baseline, after initial drug administration, and on weeks 6 and 12 of drug administration; and weeks 16 and 20 after cessation of drug application.

M.D. Anderson Cancer Center

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%

4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio

4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

NaCl 0.9 %

Franck JEGOUX, PH

Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue.

The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.

The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication.

Patients will be randomized into two groups :

* preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group)
* preoperative oral preparation with chlorhexidine (experimental group)

A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)

Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer

The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)

The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)

The type of germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The number of CFU/ml of pathogens germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC
Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine	NCT02479347	Wound Infection Breast Neoplasm...	Chlorhexidine Povidone-Iodine	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC
Chlorhexidine Gel Therapy for Cariogenic Oral Microflora	NCT01036412	Head and Neck C...	1% Chlorhexidin... Surveys	18 Years -	M.D. Anderson Cancer Center
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer	NCT02753387	Bacterial Infec...	Chlorhexidine NaCl 0.9 %	18 Years -	Rennes University Hospital

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