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

NCT05693597 | Completed Phase 2 DMC

• 1 other identifier: N.sativavsRID BreastCancerpt.
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Keywords

Nigella sativa; Black seed; Baraka; Radiation induced dermatitis; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of development of radiation induced dermatitis

  If the patient developed Radiation induced dermatitis or not

  6 weeks

Secondary Outcomes (5)

• Evaluation of Severity of RID developed

  6 weeks

• Evaluation of Pain Intensity

  6 weeks

• Evaluation of Incidence of Treatment-Emergent Adverse Events

  6 weeks

• Evaluation of Quality of life

  6 weeks

• Evaluation of Time to develop grade 2 RID

  6 weeks

Study Arms (3)

Group I (control)

NO INTERVENTION

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)

EXPERIMENTAL

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.

Drug: Imtenan Oil

Group III (Oral intervention)

EXPERIMENTAL

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

Drug: Baraka Capsules

Interventions

Imtenan Oil DRUG

Cold Press Oil

Group II (Topical intervention)

Baraka Capsules DRUG

Soft Gelatin Capsules

Group III (Oral intervention)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive, early stage breast carcinoma scheduled for adjuvant radiotherapy.
• Women aged ≥18 years.

You may not qualify if:

• Prior exposure to radiotherapy
• Patients with generalized skin disorder
• Patients who failed to sign the written consent

Sponsors & Collaborators

• German University in Cairo: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Related Links

• 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
• A Review of Medicinal Uses and Pharmacological Activities of Nigella sativa
• Antioxidant activity of Nigella sativa essential oil
• 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
• 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

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Mayar Waleed Salaheldin Aly, M.Sc.

  German University in Cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer Assistant

Model Details: 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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 23, 2023
• Study Start: January 24, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)