Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05693597 |
| Other study ID # |
N.sativavsRID BreastCancerpt. |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2023 |
| Est. completion date |
February 20, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
German University in Cairo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
