- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693597
Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Mayar Waleed Salaheldin Aly, M.Sc.
- Phone Number: 00201097952433
- Email: mayar.waleed@guc.edu.eg
Study Contact Backup
- Name: Mohamed Hassan Solayman, PhD
- Phone Number: 00201005882550
- Email: mohamed.solayman@guc.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Ain Shams University Hospital
-
Contact:
- Hagar Ibrahim Elghazawy, MD
- Phone Number: 00201006232406
- Email: dr.hagar.elghazawy@med.asu.edu.eg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically confirmed invasive, early stage breast carcinoma scheduled for adjuvant radiotherapy.
- Women aged ≥18 years.
Exclusion Criteria:
- Prior exposure to radiotherapy
- Patients with generalized skin disorder
- Patients who failed to sign the written consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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).
|
|
Experimental: 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.
|
Cold Press Oil
|
Experimental: Group III (Oral intervention)
Patients will receive Baraka ® N. sativa gelatin capsules; 40-80 mg/Kg/day; from day 1 of radiation therapy till the end
|
Soft Gelatin Capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of development of radiation induced dermatitis
Time Frame: 6 weeks
|
If the patient developed Radiation induced dermatitis or not
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Severity of RID developed
Time Frame: 6 weeks
|
The severity of moist desquamation assessed by Common Terminology Criteria for Adverse Events (CTCAE, version6) criteria based on the clinical presentation.
|
6 weeks
|
Evaluation of Incidence of Treatment-Emergent Adverse Events
Time Frame: 6 weeks
|
Patients will be educated and instructed to report any adverse events
|
6 weeks
|
Evaluation of Quality of life
Time Frame: 6 weeks
|
Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)
|
6 weeks
|
Evaluation of Time to develop grade 2 RID
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Evaluation of Pain Intensity
Time Frame: 6 weeks
|
Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mayar Waleed Salaheldin Aly, M.Sc., German University in Cairo
Publications and helpful links
Helpful Links
- Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature
- Radiation-induced skin reactions: mechanism and treatment
- Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group
- The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline
- Symptom Management Guidelines: RADIATION DERMATITIS
- Prevention and management of radiation-induced dermatitis, mucositis, and xerostomia
- A Review of Medicinal Uses and Pharmacological Activities of Nigella sativa
- Antioxidant activity of Nigella sativa essential oil
- The Anti-Inflammatory Activity of Nigella sativa Balm Sticks
- Anti-Inflammatory Effect of Nigella Sativa Oil on Chemoradiation-Induced Oral Mucositis in Patients With Head and Neck Cancers
- Evaluation of efficacy, safety and antioxidant effect of Nigella sativa in patients with psoriasis: A randomized clinical trial
- Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract
- Protective role of black seed oil in doxorubicin-induced cardiac toxicity in children with acute lymphoblastic leukemia
- Protective Effect of Nigella sativa Oil against Methotrexate Induced Hepatotoxicity in Children with Acute Lymphoblastic Leukemia
- Effectiveness of Nigella sativa Oil in the Management of Rheumatoid Arthritis Patients: A Placebo Controlled Study
- Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases
- Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use
- Ameliorating effects of Nigella sativa oil on aggravation of inflammation, oxidative stress and cytotoxicity induced by smokeless tobacco extract in an allergic asthma model in Wistar rats
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N.sativavsRID BreastCancerpt.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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