Clinical trial NCT04995328: Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
Official title: A Single Center, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Keywords: Lonicera japonica
breast cancer
head and neck cancer
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The radiotherapy after surgery reduces the risk of recurrence and death is widely used for standard treatment for cancer including breast cancer and head and neck cancer. However, radiation dermatitis is a common side effect and major adverse event of radiotherapy. Radiation induces skin inflammation resulting in redness, itchiness and peeling skin. Radiation dermatitis may be acute or chronic. Acute skin changes occur within 90 days of initiating therapy due to inflammation and DNA damage and chronic skin changes may occur after several weeks or years. Radiation-irritated skin is a treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin structure and causes a variety of symptoms of cuticle thinning, reducing of collagen in subcutaneous, sweat glands damage, sebaceous glands damage and basal membrane damage. These conditions lead patients to lost work productivity, wound care costs, social isolation, altered body image and affect a patient's quality of life and mental health both during and after treatment and even interrupts the treatment schedule.

The treatment of radiation dermatitis is an essential component of radiotherapy. The common treatment includes agents and other dressing products, such as corticosteroid cream, hyaluronic acid, aloe and sucralfate, which are used to prevent or reduce severity of dermatitis. But there is no clear therapeutic or nursing guideline supporting continuous treatment of radiation dermatitis by topical agents currently.

In this study, Radiation Care® gel which contain Japanese honeysuckle extract will be used in breast and head and neck cancer patients to test the safety and efficacy to prevent radiation dermatitis and alleviate their radiation-irritated skin symptoms.

The primary objective of this study is to evaluate the clinical outcomes of "Radiation Care" gel application in breast cancer and head and neck cancer patients who have radiation dermatitis or radiation-irritated skin due to the radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Participants must be males or non-pregnant or non-lactating females at least 20 years of age.
* Subject must meet one of the following conditions:

  1. Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
  2. Diagnosis of epithelial carcinoma of nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, paranasal sinus and salivary glands which were treated with or without operation, concurrent chemotherapy is accepted, in head and neck cancer patients.
* Patients were scheduled to receive at least three sessions of radiotherapy per week (1 session per day) for at least five weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 50 Gy.
* Participant willing and must give signed informed consent.

Exclusion Criteria:

* Prior breast reconstructions, implants, and/or expanders.
* Previous radiotherapy to the area to be treated with radiation therapy (head and neck area or breast and thorax areas).
* Concurrent chemotherapy in breast cancer patients.
* Concurrent targeted therapy in head and neck cancer patients.
* Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
* Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections, rashes or unhealed wounds in the radiation field or systemic lupus erythematosus (SLE).
* 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.
* Participation in any clinical trial in the prior 30 days from baseline.
* Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Primary outcomes:
measure: To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5.
timeFrame: at 5 weeks
Secondary outcomes:
measure: To evaluate radiation-irritated situation after 3 months of Radiation Care® gel application in breast cancer and head and neck cancer patients who completed the post-operative radiotherapy.
timeFrame: Day0 (baseline), 1-Week, 2-Week, 3-Week, 4-Week, 5-Week, 6-Week, 7-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week
measure: To compare the moisture percentage at the radiotherapy site from baseline to follow-up visit.
timeFrame: Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)
measure: The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
timeFrame: Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
citation: Ahn S, Sung K, Kim HJ, Choi YE, Lee YK, Kim JS, Lee SK, Roh JY. Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. In Vivo. 2020 Jan-Feb;34(1):413-422. doi: 10.21873/invivo.11790.
citation: Clemenson C, Liu W, Bricout D, Soyez-Herkert L, Chargari C, Mondini M, Haddad R, Wang-Zhang X, Benel L, Bloy C, Deutsch E. Preventing Radiation-Induced Injury by Topical Application of an Amifostine Metabolite-Loaded Thermogel. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1141-1152. doi: 10.1016/j.ijrobp.2019.04.031. Epub 2019 May 4.
citation: Wang L, Jiang Q, Hu J, Zhang Y, Li J. Research Progress on Chemical Constituents of Lonicerae japonicae flos. Biomed Res Int. 2016;2016:8968940. doi: 10.1155/2016/8968940. Epub 2016 Jun 14.
citation: Jeong YT, Jeong SC, Hwang JS, Kim JH. Modulation effects of sweroside isolated from the Lonicera japonica on melanin synthesis. Chem Biol Interact. 2015 Aug 5;238:33-9. doi: 10.1016/j.cbi.2015.05.022. Epub 2015 Jun 5.
citation: Wu L. Effect of chlorogenic acid on antioxidant activity of Flos Lonicerae extracts. J Zhejiang Univ Sci B. 2007 Sep;8(9):673-9. doi: 10.1631/jzus.2007.B0673.
citation: Liao Y, Dong S, Kiyama R, Cai P, Liu L, Shen H. Flos lonicerae extracts and chlorogenic acid protect human umbilical vein endothelial cells from the toxic damage of perfluorooctane sulphonate. Inflammation. 2013 Jun;36(3):767-79. doi: 10.1007/s10753-013-9603-5.