Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitogens

Clinical utility of ctDNA analysis for treatment decision

Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer

Clinical utility of ctDNA analysis for treatment decision

Plasma circulating DNA analysis

Karen-Lise G Spindler

The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.

The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy

Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression

Plasma samles for circulating DNA analysis

OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -

OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions

Feasibility measures

Identification of wildtype or mutated status and results delivered to clinicians

* Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days
* Detailed mutation type characterization is provided retrospectively.

Failure parameters

* Quality of samples; PB \> 5%, CPP1 major loss \< 10%
* Transportation \> 3 week days
* Analysis \> 3 working days
* Total results delivered \> 7 days.

Retrospective comparison of tumor mutation and plasma mutation analysis at baseline

Rate of Ectoderm mutations at time of progression

Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.

Karen-Lise Garm Spindler

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Head and Neck Neoplasms

Quality of Life

Herbal and Botanical

Lemon Balm

Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment.

Use of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment.

The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers

Cicaplast Balm B5

Dexeryl

Jérôme FAYETTE, Doctor

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).

Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).

The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.

Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.

In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.

There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more.

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days

Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)

Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers

Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm

Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm

Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)

Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4

Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity

Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm

Topical observance will be evaluated in each arm by data collection by each patient in a diary

Evaluation of the rate of patients needing to use dermocorticoids.

Centre Leon Berard

Infections

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Paronychia

Communicable Diseases

Skin Diseases

Skin Diseases, Infectious

Nail Diseases

Anti-Infective Agents

Anti-Bacterial Agents

Silver Nitrate

Antibiotics, Antitubercular

Adrenergic beta-Antagonists

Anti-Infective Agents, Local

Patients in the intervention arm will receive Kinesiology tape wrapping to separate the nail plate from the inflamed periungual tissue in addition to conventional treatment. This intervention will be applied at outpatient visits or during hospitalization. If the Kinesiology tape falls off, patients can either replace it themselves or leave it off until the next outpatient visit or unexpected hospitalization.

Patients in this arm will receive management according to routine clinical practice, including chemical cauterization with silver nitrate, with or without topical antiseptics, topical steroids, topical beta-blockers, systemic steroids, and systemic antibiotics. The above treatment will be applied at outpatient visits or during hospitalization.

Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months

Kinesiology tape wrapping

Conventional treatment including silver nitrate cauterization, with or without topical antiseptics, topical steroids, topical beta-blockers, short-term systemic antibiotics, systemic steroids for 3 months

Conventional treatment including silver nitrate cauterization

Ting-Jung Hsu, M.D.

Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.

In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.

Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors

A Single-center, Randomized, Open-labelled Trial to Evaluate the Efficacy and Safety of the Kinesiology Tape for the Treatment of Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors in Cancer Patients

Patients rate the severity of pain over the tender point of the affected big toe on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.

The SPOT evaluates the severity of the affected big toe based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. The total score ranges from 0 to 12.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -	NCT03750175	Colorectal Canc... Circulating Tum... KRAS Gene Mutat... NRAS Gene Mutat... BRAF Gene Mutat... Epidermal Growt...	Plasma circulat...	18 Years -	Aarhus University Hospital
OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -	NCT03750175	Colorectal Canc... Circulating Tum... KRAS Gene Mutat... NRAS Gene Mutat... BRAF Gene Mutat... Epidermal Growt...	Plasma circulat...	18 Years -	Aarhus University Hospital
Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)	NCT03421912	Head and Neck S... Colorectal Canc... Non Small Cell ... Epidermal Growt...	Cicaplast Balm ... Dexeryl	18 Years -	Centre Leon Berard
Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors	NCT06411093	Paronychia Epidermal Growt...	Kinesiology tap... Conventional tr...	20 Years - 100 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for epidermal growth factor receptor inhibitor