Colorectal Cancer, Epidermal Growth Factor Receptor Inhibitor, Head and Neck Squamous Cell Carcinoma, Non Small Cell Lung Cancer
Conditions
Keywords
Prevention strategy, Cutaneous toxicity, Quality of life, Patient satisfaction, Dermatology Life Quality Index (DLQI), Epidermal Repair Score (SCOREPI), Topical treatment
Brief summary
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
Detailed description
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
Interventions
OTHERCicaplast Balm B5
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
OTHERDexeryl
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
Sponsors
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations. * Treated for the first time by an iEGFR having received a marketing authorization. * Having signed a consent to participate in the study. * Affiliated to a health insurance plan (or beneficiary of such a plan).
Exclusion criteria
* Concomitant radiotherapy. * Unresolved skin toxicity from previous treatment, whatever it may be. * Concomitant use of other topical treatments. * Known hypersensitivity to at least one of the components of the topicals used. * Pregnant or lactating women. * Participation in another clinical trial (even if supportive care)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall patient satisfaction after 30 days treatment | After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days | Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of life | At inclusion, after 30 and 60 days of treatment | Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm |
| Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI) | After 15, 30 and 60 days of treatment | Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI) |
| Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4 | After 15, 30 and 60 days of treatment | Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4 |
| Overall patient satisfaction after 60 days treatment | After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days | Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm |
| DLQI and SCOREPI scores correlation | After 30 and 60 days of treatment | Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm |
| Topical observance | Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment | Topical observance will be evaluated in each arm by data collection by each patient in a diary |
| Use rate of dermocorticoids | Continously up to 60 days after starting treatment | Evaluation of the rate of patients needing to use dermocorticoids. |
| Modification/Interruption/Discontinuing iEGFR treatment rate | Continuously up to 30 days after starting treatment | Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity |
Countries
France
Outcome results
None listed