Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03421912 |
Other study ID # |
CICAFIX - ET17-011 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 16, 2018 |
Est. completion date |
May 11, 2021 |
Study information
Verified date |
July 2021 |
Source |
Centre Leon Berard |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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