An interventional study of Cicaplast Balm B5 and Dexeryl in Head and Neck Squamous Cell Carcinoma, Colorectal Cancer and Non Small Cell Lung Cancer, sponsored by Centre Leon Berard. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-09.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Supportive care
Among 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France — 46 open to participants now, 80 under way, 20 of them phase 3. Squamous Cell Carcinoma of Head and Neck · France.
Among the 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France, this one is the 118th largest by enrollment of the 197 interventional ones that give a count, is one of 15 that started in 2018, is one of 32 with no phase, and was the 94th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →46 of the 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France are open now. Recruiting first, the newest first:
Corbus Pharmaceuticals Inc. · Sites in France, United States, Austria and 11 more countries
Groupe Oncologie Radiotherapie Tete et Cou · Sites in France
Regeneron Pharmaceuticals · Sites in France, United States, Australia and 3 more countries
University Hospital, Brest · Sites in France
Groupe Oncologie Radiotherapie Tete et Cou · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
215 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 86 · Phase 3 49
First in 1994; this study’s year is marked. 15 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 102 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 131 across the 197 interventional studies, 140 across the 17 observational. Of the 127 that completed or were terminated, 43 (34%) have results posted.
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112 of 215 have an industry lead sponsor. The 10 most frequent:
Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
Centre Leon Berard has 8 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
18 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03576417Phase 3Groupe Oncologie Radiotherapie Tete et CouA Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck | 2027-08 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT03070366Groupe Oncologie Radiotherapie Tete et CouStereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC | 2026-12 |
| NCT07151040One-carbon Therapeutics ABPhase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors | 2026-12 |
Among the 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Cicaplast Balm B5
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.
Other: Dexeryl
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
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
Overall patient satisfaction after 30 days treatment
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
Time frame: After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days
Overall patient satisfaction after 60 days treatment
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
Time frame: After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days
Patient Quality of life
Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm
Time frame: At inclusion, after 30 and 60 days of treatment
Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI)
Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)
Time frame: After 15, 30 and 60 days of treatment
Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: After 15, 30 and 60 days of treatment
Modification/Interruption/Discontinuing iEGFR treatment rate
Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity
Time frame: Continuously up to 30 days after starting treatment
DLQI and SCOREPI scores correlation
Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm
Time frame: After 30 and 60 days of treatment
Topical observance
Topical observance will be evaluated in each arm by data collection by each patient in a diary
Time frame: Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment
Use rate of dermocorticoids
Evaluation of the rate of patients needing to use dermocorticoids.
Time frame: Continously up to 60 days after starting treatment
Ran from Feb 2018 to primary completion in Apr 2021, 37 months.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's 37 months is below that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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