Clinical trial NCT05284487: Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation-induced Dermatitis
Lead sponsor: Welcare Industries SpA
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective

- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.

Secondary objectives:

* To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
* To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
* To investigate safety and tolerability of Jalosome®.
* To investigate patient's compliance to Jalosome® treatment.
* To investigate patient's global satisfaction with Jalosome® treatment.

Detailed description: Primary endpoint:

* Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.

  • Secondary endpoints:
* Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
* Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
* Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
* RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
* Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
* Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
* Patient's compliance to Jalosome® treatment.
* Patient's global satisfaction with Jalosome® treatment.
* Jalosome® overall safety and tolerability.

Study design:

Monocentric, randomized, double-blind, placebo controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

* Male and female subject aged ≥18 years old.
* Performance status 0-1.
* Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
* Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
* Willingness and ability to give informed consent and comply with study procedures.

Exclusion Criteria:

* Pregnant or lactating women.
* Previous RT on the head and neck area.
* Planned to receive concurrent cetuximab.
* Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
* Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
* Use of a tissue-equivalent bolus.
* Use of over-the-counter topical medications containing steroids.
* Presence of rashes or unhealed wounds in the radiation field.
* Recent sun exposure (\<1 month).
* Mental conditions that could adversely affect subject's adherence to the study.

Primary outcomes:
measure: Time to development of G2 RID
timeFrame: 9 weeks
Secondary outcomes:
measure: Subjects without G2 RID at the end of RT
timeFrame: 9 weeks
measure: Subjects without G2 RID at different timepoints
timeFrame: 9 weeks
measure: Worst skin toxicity
timeFrame: 9 weeks
measure: RID grade on the RISRAS
timeFrame: 9 weeks
measure: PRO-Skindex-16 questionnaire score
timeFrame: 9 weeks
measure: Pain measured by NRS
timeFrame: 9 weeks
measure: Compliance
timeFrame: 9 weeks
measure: Adverse events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS
Study officials:
affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
name: Nicola Alessandro Iacovelli
role: PRINCIPAL_INVESTIGATOR
References: