search
Back to results

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

Primary Purpose

Radiation Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Imtenan Oil
Baraka Capsules
Sponsored by
German University in Cairo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Dermatitis focused on measuring Nigella sativa, Black seed, Baraka, Radiation induced dermatitis, Breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group I (control)

Group II (Topical intervention)

Group III (Oral intervention)

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of development of radiation induced dermatitis
If the patient developed Radiation induced dermatitis or not

Secondary Outcome Measures

Evaluation of Severity of RID developed
The severity of moist desquamation assessed by Common Terminology Criteria for Adverse Events (CTCAE, version6) criteria based on the clinical presentation.
Evaluation of Pain Intensity
Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain
Evaluation of Incidence of Treatment-Emergent Adverse Events
Patients will be educated and instructed to report any adverse events
Evaluation of Quality of life
Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)
Evaluation of Time to develop grade 2 RID
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.

Full Information

First Posted
January 4, 2023
Last Updated
January 30, 2023
Sponsor
German University in Cairo
Collaborators
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05693597
Brief Title
Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients
Official Title
Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German University in Cairo
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Nigella sativa, Black seed, Baraka, Radiation induced dermatitis, Breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (control)
Arm Type
No Intervention
Arm Description
Patients will not receive any prophylactic intervention, as there is no standard of care for prophylaxis to the radiation induced dermatitis (RID).
Arm Title
Group II (Topical intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group III (Oral intervention)
Arm Type
Experimental
Arm Description
Patients will receive Baraka ® N. sativa gelatin capsules; 40-80 mg/Kg/day; from day 1 of radiation therapy till the end
Intervention Type
Drug
Intervention Name(s)
Imtenan Oil
Intervention Description
Cold Press Oil
Intervention Type
Drug
Intervention Name(s)
Baraka Capsules
Intervention Description
Soft Gelatin Capsules
Primary Outcome Measure Information:
Title
Incidence of development of radiation induced dermatitis
Description
If the patient developed Radiation induced dermatitis or not
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Evaluation of Severity of RID developed
Description
The severity of moist desquamation assessed by Common Terminology Criteria for Adverse Events (CTCAE, version6) criteria based on the clinical presentation.
Time Frame
6 weeks
Title
Evaluation of Pain Intensity
Description
Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain
Time Frame
6 weeks
Title
Evaluation of Incidence of Treatment-Emergent Adverse Events
Description
Patients will be educated and instructed to report any adverse events
Time Frame
6 weeks
Title
Evaluation of Quality of life
Description
Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)
Time Frame
6 weeks
Title
Evaluation of Time to develop grade 2 RID
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mayar Waleed Salaheldin Aly, M.Sc.
Phone
00201097952433
Email
mayar.waleed@guc.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Hassan Solayman, PhD
Phone
00201005882550
Email
mohamed.solayman@guc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayar Waleed Salaheldin Aly, M.Sc.
Organizational Affiliation
German University in Cairo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hagar Ibrahim Elghazawy, MD
Phone
00201006232406
Email
dr.hagar.elghazawy@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mdpi.com/1718-7729/17/4/493
Description
Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature
URL
https://www.dovepress.com/radiation-induced-skin-reactions-mechanism-and-treatment-peer-reviewed-fulltext-article-CMAR
Description
Radiation-induced skin reactions: mechanism and treatment
URL
https://link.springer.com/article/10.1007/s00520-013-1896-2
Description
Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group
URL
https://link.springer.com/article/10.1007/s00520-006-0063-4
Description
The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline
URL
http://www.bccancer.bc.ca/nursing-site/Documents/Symptom%20Management%20Guidelines/14RadiationDermatitis.pdf
Description
Symptom Management Guidelines: RADIATION DERMATITIS
URL
https://academic.oup.com/ajhp/article-abstract/70/12/1025/5112266?redirectedFrom=fulltext
Description
Prevention and management of radiation-induced dermatitis, mucositis, and xerostomia
URL
https://scialert.net/abstract/?doi=pjbs.2004.441.451
Description
A Review of Medicinal Uses and Pharmacological Activities of Nigella sativa
URL
https://pubmed.ncbi.nlm.nih.gov/10925395/
Description
Antioxidant activity of Nigella sativa essential oil
URL
https://pesquisa.bvsalud.org/portal/resource/pt/ibc-177883
Description
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
URL
https://www.mdpi.com/2218-0532/87/1/3
Description
The Anti-Inflammatory Activity of Nigella sativa Balm Sticks
URL
https://innovareacademics.in/journals/index.php/ijcpr/article/view/35704
Description
Anti-Inflammatory Effect of Nigella Sativa Oil on Chemoradiation-Induced Oral Mucositis in Patients With Head and Neck Cancers
URL
https://www.jceionline.org/article/evaluation-of-efficacy-safety-and-antioxidant-effect-of-nigella-sativa-in-patients-with-psoriasis-a-3557
Description
Evaluation of efficacy, safety and antioxidant effect of Nigella sativa in patients with psoriasis: A randomized clinical trial
URL
https://www.dustri.com/article_response_page.html?artId=4697&doi=10.5414/CPP46295&L=0
Description
Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract
URL
https://europepmc.org/article/med/31964219
Description
Protective role of black seed oil in doxorubicin-induced cardiac toxicity in children with acute lymphoblastic leukemia
URL
https://www.longdom.org/open-access/protective-effect-of-nigella-sativa-oil-against-methotrexate-induced-hepatotoxicity-in-children-with-acute-lymphoblastic-leukemia-2329-6917.1000123.pdf
Description
Protective Effect of Nigella sativa Oil against Methotrexate Induced Hepatotoxicity in Children with Acute Lymphoblastic Leukemia
URL
https://tahomaclinic.com/Private/Articles3/RA/Gheita%202012%20-%20Effectiveness%20of%20Nigella%20sativa%20oil%20in%20rheumatoid%20arthritis.pdf
Description
Effectiveness of Nigella sativa Oil in the Management of Rheumatoid Arthritis Patients: A Placebo Controlled Study
URL
https://pubmed.ncbi.nlm.nih.gov/14669258/
Description
Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases
URL
https://europepmc.org/article/med/8033378
Description
Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use

Learn more about this trial

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

We'll reach out to this number within 24 hrs