Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Dermatitis

Radiodermatitis

Skin Diseases

Radiation Injuries

Herbal and Botanical

All Drugs and Chemicals

Nigella

Patients will not receive any prophylactic intervention, as there is no standard of care for prophylaxis to the radiation induced dermatitis (RID).

Patients will receive Imtenan ® N. sativa oil apply 1.5 mls; twice daily; not sooner than 2 hours before and after radiation therapy; from day 1 of radiation therapy till the end.

Patients will receive Baraka ® N. sativa gelatin capsules; 40-80 mg/Kg/day; from day 1 of radiation therapy till the end

Imtenan Oil

Baraka Capsules

Mayar Waleed Salaheldin Aly, M.Sc.

Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. Nigella sativa is an herbal medicine whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Nigella sativa as a prophylactic method against the development of RID.

Radiation induced dermatitis (RID) is one of the most commonly reported adverse events of breast radiation therapy (RT).Radiation therapy toxicity is exhibited within hours to weeks of exposure and persisting throughout the course of treatment. Radiation induced dermatitis is a result of generation of reactive oxygen species (ROSs), which in return induces epidermal and dermal inflammatory responses. Radiation causes structural tissue damage, which trigger production of pro-inflammatory mediators; as NF-κB, iNOS, COX-2, EGFR, MCP-1, and cytokines such as IL-1, IL-2, IL-6, TNF-a, and IFN- γ, and immune-stimulatory response; involving an increased movement of leukocytes from the blood into the irradiated tissues. Subsequently erythema, ulceration, and edema are developed. This is then followed by thinning of the epidermis, accompanied with degeneration of glands, which manifests as dry desquamation. If damage to the basal cells and glands is more severe, moist desquamation occur. From previous, it can be deduced that inflammatory response plays a significant role in the radiotherapy induced dermatitis.

There are many agents that are used in the management of RID in the clinical settings, however, up till now there is none supported by the guidelines. Radiation induced dermatitis occurrence, not only could it impair the patient's quality of life but it could also affect the RT course of treatment, which could negatively influence the cancer treatment. Therefore more effort is needed to find a method of prevention of RID, resulting from breast RT, especially that there is no standard of care for prophylaxis to the radiation induced dermatitis (RID).

Nigella sativa is herbal medicine that has been widely used in different parts of the world by different cultures. It has been used traditionally as a remedy for several diseases including fever, cough, chronic headache, dizziness, back pain, dysmenorrhea, obesity, diabetes, infection and inflammation, hypertension, and gastrointestinal disorders such as flatulence, and dysentery. Preclinical and clinical studies have demonstrated the anti-inflammatory, immunomodulatory, antioxidant, analgesic, and antimicrobial properties of N. sativa.

Thymoquinone (TQ) is the prominent constituent of Nigella sativa, to which the biological properties have been attributed. Thymoquinone can act as a potent free radical and superoxide radical scavenger at both nanomolar and micromolar range, respectively. As well as, its beneficial effects on antioxidant enzymes, and its detrimental effects on pro-inflammatory mediators/cytokines, and pro-inflammatory transcription factor; nuclear factor kappa B (NF-κB).

Based on literature, Nigella sativa has been shown to have antioxidant and anti-inflammatory effects. As, both the fixed oil of N. sativa, as well as thymoquinone (the main compound of the essential oil), were proven to inhibit non-enzymatic lipid peroxidation and have an appreciable free radical scavenging properties. Furthermore, orally administered Nigella sativa oil showed a reduction of IL-4 and NO production in rats. Additionally, Thymoquinone showed anti-inflammatory activity through inhibition of cyclooxygenase (COX) and 5-lipooxygenase (5-LPO), as well as through lowering TNF-α and IL-1β levels in arthritis in rats. It is worth mentioning that thymoquinone was proven to significantly reduce pancreatic ductal adenocarcinoma cell synthesis of MCP-1, TNF-a, IL-1β and Cox-2. It also inhibited the constitutive and TNF-a-mediated activation of NF-kB.

Hence, many clinical trials have been using Nigella sativa, to see its anti-inflammatory and antioxidant effects in different indications including its anti-inflammatory effect in treatment of oral mucositis in head and neck cancers patients, and managing dermatitis in breast cancer patients, and its antioxidant effect in patients with psoriasis, and acute tonsillo-pharyngitis, and many more, where Nigella sativa showed to be not only safe but effective as well. Nigella sativa oil, Baraka ® gelatin capsules, has been used in doses up to 80 mg/kg/day in children with acute lymphoblastic leukemia, in the protection against doxorubicin-induced cardiac toxicity and in the protection against Methotrexate induced hepatotoxicity, where it was effective and safe.

Group I (control): Patients will not receive any prophylactic intervention, as there is no standard of care for prophylaxis to the radiation induced dermatitis (RID).

Group II (Topical intervention): Patients will receive Imtenan ® N. sativa oil apply 1.5 mls; twice daily; not sooner than 2 hours before and after radiation therapy; from day 1 of radiation therapy till the end.

Group III (Oral intervention): Patients will receive Baraka ® N. sativa gelatin capsules; 40mg/Kg/day; from day 1 of radiation therapy till the end

Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients

If the patient developed Radiation induced dermatitis or not

The severity of moist desquamation assessed by Common Terminology Criteria for Adverse Events (CTCAE, version6) criteria based on the clinical presentation.

Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain

Patients will be educated and instructed to report any adverse events

Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)

Time to develop grade 2 RID incidence, will be assessed by Common Terminology Criteria for Adverse Events (CTCAE, version6) criteria based on the clinical presentation.

Ain Shams University

German University in Cairo

Clinical Pharmacy Lecturer Assistant

Keratosis, Actinic

Keratosis

Precancerous Conditions

Micronutrients

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks

Nigella sativa

Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Placebo

Mir Misbahuddin, MBBS, PhD

Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis

Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients

Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.

Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.

Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.

To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients	NCT05693597	Radiation Derma...	Imtenan Oil Baraka Capsules	18 Years - 75 Years	German University in Cairo
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis	NCT01735097	Arsenical Kerat...	Vitamin E Nigella sativa Placebo	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis	NCT01735097	Arsenical Kerat...	Vitamin E Nigella sativa Placebo	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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