RU2586043C1 - Method for prevention and treatment of complications in radiation therapy of skin cancer - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention can be used for prevention and treatment of complications during radiation therapy of skin cancer. That is ensured by patient's preparation for therapy by local skin treatment before and after each session radiation therapy. At that, local skin treatment is carried out by application of sodium hyaluronate with molecular weight of 30,000 Da and viscosity of 20-45 Pa·s^-1 on the tumour area and 1-1.5 cm of intact tissues surrounding the tumour. From above, these skin areas are closed with a “Coletex-CA-Hem” drape and left for 4-5 hours before every session of radiation therapy. Drape is moistened by measure of drying. After the radiation therapy session, a moistened “Coletex-GKd-0.4” drape is applied on the same areas for 5-7 hours. Upon completion of the course of the radiation therapy, a moistened “Coletex-ADL” drape is daily applied on the exposure area during 1-2 weeks.

EFFECT: method provides reduction of initial manifestations of radiation reactions on the skin, their later development at reduced degree of manifestation and duration of the clinical course, rapid relief of pain syndrome.

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Description

The invention relates to medicine, namely to a method for the prevention and treatment of complications of radiation therapy for skin cancer, and can be used in oncology to reduce the degree of radiation reactions.

A known method of treating cancer patients with radiation therapy using a radiosensitizer of hypoxic cells - metronidazole before radiation exposure (RF Patent No. 2089247, IPC A61N 5/10, publ. 1997). In this method, radiation therapy is carried out in combination with the intratumoral administration of metronidazole by applying to the tumor textile material containing a layer of sodium alginate with metronidazole and dimethyl sulfoxide in a mass ratio of the latter of 2: 0.5-1.0, respectively.

The disadvantage of this method is the appearance of local radiation reactions in the form of hyperemia, dry and wet radiodermatitis and their severe course.

The closest is a method for the prevention and treatment of complications in radiation and / or chemotherapy of cancer of various localization (Patent No. 2232999, IPC A61P 37/02, 2008), which includes preparing the patient for therapy by local skin treatment before and after radiation therapy. Local treatment of the skin and the organs of the mucous membranes exposed to chemo and / or radiation exposure with oil extracts of medicinal plants is carried out locally, an immunomodulating preparation and an adsorbent are administered during and after a course of radiation and / or chemotherapy, and pharmacopoeial medicinal plants are additionally orally administered including immunomodulating adaptogen and adsorbent. In this case, local treatment of the skin and mucous membranes is carried out after each session of radiation and / or chemotherapy, and the introduction of the collection, plant adaptogen and plant adsorbent is carried out in therapeutic doses, with intervals between the introduction of each of them.

The disadvantages of this method are that the concentrated oil extracts dry the surface of the tumor and the skin, which requires their dilution (dilution), and therefore leads to a decrease in the necessary therapeutic effect. Oral administration of herbal preparations, adaptogens and adsorbents significantly reduces the possibility of their use in case of dyspeptic symptoms, such as nausea and vomiting, since even when they are stopped with antiemetic drugs, the absorption processes in the gastrointestinal tract are disturbed and the adequate intake of active substances in the body does not seems possible.

The task posed by the authors is to eliminate these shortcomings, to develop a method for the non-invasive entry of drugs into the tumor and surrounding intact tissues, and also, regardless of the digestive processes in the gastrointestinal tract, to provide a therapeutic dose of drugs for the prevention and treatment of complications radiation therapy.

To solve the problem for the prevention and treatment of complications of radiation therapy for skin cancer, including preparing the patient for therapy by local skin treatment before and after a radiation therapy session, it is proposed that the skin be treated locally by applying sodium hyaluronate to the tumor area and 1-1.5 cm of intact tissues around the tumor with a molecular mass of 30,000 Yes, which allows to overcome the transepidermal barrier, stimulate the growth of blood and lymphatic capillaries, thereby improving microcirculation and skin nutrition; and a viscosity of 20-45 Pa · s ^-1 , which allows for uniform distribution over the entire damaged area, rapid hydration and penetration of the active substance through the skin barrier. From above, these skin areas are covered with a Coletex-SA-Gem wet towel and left for 4-5 hours before each radiation therapy session, and the towel is not moistened as it dries, since the moisturizing effect is maintained by the viscosity of sodium hyaluronate, and after the radiation therapy session on the same areas, the Coletex-GKD-0.4 moistened wipe for 5-7 hours, after the end of the course of radiation therapy, a daily moistened Coletex-ADL wipes is applied for 1-2 weeks.

The use of Coletex-SA-Gem wipes with sodium alginate reduces the inflammatory response of intact tissues surrounding the tumor and prevents capillary bleeding. The use of Koleteks-GKD-0.4 wipes with hydrocortisone and dimexidum helps to relieve local pain and reduce swelling in the irradiated field.

The use of Coletex-ADL wipes with dioxidine and lidocaine eliminates the pain syndrome and contributes to the rapid relief of moist radiodermatitis and the fastest epithelization of the skin of the irradiation field, in addition, it does not adhere to the irradiation field.

The implementation of the method shown in specific clinical examples.

Example 1

Patient M., 63 years old, was admitted with a diagnosis of IctT1NoMo skin cancer. Histologically: squamous cell carcinoma. Local status: a tumor of the forehead skin, without deep infiltration, size 1.2 × 0.8 × 0.5 cm.

The skin tumor and surrounding intact tissues were treated with a 3% hydrogen peroxide solution at a distance of 1-1.5 cm and, before each irradiation session, sodium hyaluronate with a molecular weight of 30,000 Da and a viscosity of 20-45 Pa · s ^{-1 was} applied to this area, then closed with a napkin "Coletex-SA-Gem" with sodium alginate for 4 hours. Before the radiation therapy session, the napkin was removed.

Next, a short-distance (close-focus) X-ray therapy was carried out under physical and technical conditions: a half-weakening layer of 1.0 mm aluminum, an irradiation field exceeding the size of the tumor by 15 mm, so that the edge of the tube receded from the visible edge of the tumor by at least 5 mm; at single focal doses (ROD) of 6 Gy, 5 sessions of radiation therapy (RT) were carried out to a total focal dose (SOD) of 30 Gy in the irradiation mode 5 times a week, and then at ROD = 3.5 Gy, an additional 9 sessions were conducted before SOD = 61.5 g

After each session of radiation therapy, a Coletex-GCD-0.4 moistened napkin was applied to the irradiation area for 7 hours, reducing this exposure time sequentially to the last session to 5 hours. After the end of the course of radiation therapy, a daily moistened towel “Coletex-ADL” is applied to the irradiation zone for 10 days. No enhancement of radiation reactions of the skin was noted.

The tumor was completely regressed. Epithelialization of the skin occurred on the 18th day, which is 5-6 days shorter than that observed in the comparison group, where 10% methyluracil ointment was used as medication.

Example 2

Patient K., 54 years old, was admitted with a diagnosis of Skin cancer HctT2NoMo. Histologically: basal cell carcinoma. Local status: tumor of the skin of the left cheek, without deep infiltration, size 2.8 × 2.2 × 0.5 cm.

The treatment was carried out according to the proposed method, similar to that described in example 1. In this case, a napkin "Coletex-CA-Gem" with sodium alginate was left for 5 hours. Before the radiation therapy session, the napkin was removed.

Next, a short-distance (close-focus) X-ray therapy was carried out under physical and technical conditions: a half-weakening layer of 1.0 mm aluminum, an irradiation field exceeding the size of the tumor by 15 mm, so that the edge of the tube receded from the visible edge of the tumor by at least 5 mm; at ROD = 4 Gy, 15 RT sessions were conducted up to SOD 60 Gy in the irradiation mode 5 times a week.

After each session of radiation therapy, a Coletex-GCD-0.4 moistened napkin was applied to the irradiation area for 5 hours, and after the end of the radiation therapy course, a daily moistened Coletex-ADL napkin was applied for 14 days.

The tumor was completely regressed. Epithelialization of the skin occurred on the 20th day, which is 3-4 days shorter than that observed in the comparison group, where 10% methyluracil ointment was used as medication.

Example 3

Patient K., 54 years old, was admitted with a diagnosis of Skin cancer IIctT2NoMo. Histologically: basal cell carcinoma. Local status: tumor of the skin of the left cheek, without deep infiltration, size 2.8 × 2.2 × 0.5 cm.

The treatment was carried out according to the proposed method, before each session of radiation therapy, local skin treatment was carried out similarly to the examples described above.

Remote gamma therapy was carried out according to the dynamic dose fractionation scheme at ROD = 4 Gy, 3 sessions of RT were performed to SOD = 12 Gy, and then, at ROD = 2 Gy, in the irradiation regime, 9 sessions were performed 5 times a week to SOD = 30 Gy at the first stage of treatment.

After each session of radiation therapy, a moistened towel “Coletex-GCD-0.4” was applied to the irradiation area for 6 hours. This was followed by a 14-day break in treatment, during which a Cooletex-ADL daily moistened napkin was applied to the irradiation zone.

Then, at the second stage of treatment, a similar course of remote gamma therapy was repeated, up to SOD = 60 Gy for two stages of treatment with preliminary local treatment of the skin with sodium hyaluronate with a molecular weight of 30,000 Da and a viscosity of 20-45 Pa · s ^-1 , which was then covered with a napkin " Coletex-SA-Gem "with sodium alginate. After each radiation therapy session, a moistened towel “Coletex-GCD-0.4” was applied to the irradiation area for 6 hours. After completing the course of radiation therapy, a daily moistened Coletex-ADL napkin was applied to the irradiation zone for 10 days.

The tumor was completely regressed. Epithelialization of the skin occurred on the 20th day, which is 3-4 days shorter than that observed in the comparison group, where 10% methyluracil ointment was used as medication. At the same time, the pain syndrome after the use of Coletex wipes significantly decreased.

A method for the prevention and treatment of complications in radiation therapy of skin cancer using a complex of wipes “KOLEX-SA-GEM”, “KOLETEX-GKd-0.4” and “KOLETEX-ADL” was tested in the radiological department of MONIKA for 23 patients who underwent remote gamma -therapy and / or close-focus x-ray therapy for malignant skin tumors of the II-III stage. The comparison groups were 35 patients, in the treatment of which no radioprotectors were used.

The results of the study showed that the use of the KOLETEX napkin complex allows delaying the onset of local radiation reactions from the skin by an average of 5-7 Gy. Thus, the initial effects of a radiation reaction during radiation therapy without using the KOLETEKS napkin complex, the sides of the skin in the form of erythema were noted after summing up the average dose level of 21 ± 3.5 Gy, and in the form of dry epidermitis - 50 ± 3.5 Gy. Using the KOLETEX napkin complex, these indicators were 26 ± 3.5 Gy and 56 ± 3.5 Gy, respectively.

Due to the use of the KOLETEX napkin complex, the structure of local radiation reactions has changed in the direction of reducing their severity. The number of patients with a milder skin reaction in the form of erythema increased from 22.9 ± 7.1% to 60.9 ± 10.4% (t = 2.29; p <0.05), and the number of patients with a pronounced reaction in the form of wet epidermitis decreased from 51.4 ± 8.4% to 26.1 ± 9.4% (t = 2.01; p <0.05), the differences are statistically significant.

The study showed that the use of the complex of napkins “KOLETEX” contributed to a more rapid relief of radiation reactions, while the average duration of their subsidence decreased by 5-6 days. So, without using the KOLETEKS complex of wipes, the duration of dry epidermitis subsided on average 18 ± 3 days, of wet epidermitis was 27 ± 3 days, and when using the KOLETEKS complex of wipes, the average duration of reaction subsidence significantly decreased to 12 ± 3 and 21 ± 3 days respectively.

In 75% of patients in the control group, radiation reactions from the skin at the end of the course of radiation therapy were accompanied by pain and burning sensation in the irradiated areas for 1-2 weeks, which required the use of analgesics. When using KOLETEX-ADL wipes, these phenomena stopped in almost 100% of patients 3-4 days after the start of applications.

Treatment was satisfactorily tolerated by patients; no adverse reactions were noted.

Thus, the results of the study prove the high medical and social effectiveness of using a complex of wipes “KOLETEKS-SA-GEM”, “KOLETEX-GKd-0.4” and “KOLETEX-ADL” for the prevention and treatment of local radiation reactions of the skin, because . at the same time, their later development occurs, the degree of their severity significantly decreases, the average duration of their course decreases and the pain syndrome is quickly stopped, which significantly improves the quality of life of patients.

The method allows without special difficulties to locally, non-invasively bring to the skin tumor and the surrounding intact tissues included in the field of radiation exposure drugs that stop the initial manifestations of radiation reactions on the skin, extend the time of their occurrence and reduce the degree of their manifestation.

Claims (1)

A method for the prevention and treatment of complications of radiation therapy for skin cancer, including preparing a patient for therapy by local skin treatment before and after each radiation treatment session, characterized in that the local skin treatment is carried out by applying sodium hyaluronate with a molecular weight of 30,000 Da and a viscosity of 20-45 Pa · ^-1 to the tumor area and 1-1.5 cm of intact tissues around the tumor, from above, these skin areas are covered with a Coletex-SA-Gem napkin and left for 4-5 hours before each radiation therapy session, and the napkin as it dries moisturize, and after a radiation therapy session, a Coletex-GKd-0.4 moistened napkin is applied to the same areas for 5-7 hours, after the course of radiation therapy is completed, a daily moistened Coletex-ADL napkin is applied for 1- 2 weeks.