Colorectal Cancer Clinical Trial
Official title:
The Effect of Atorvastatin on The Prevention of 5-fluorouracil-induced Mucositis in Colorectal Cancer Patients
NCT number | NCT04151355 |
Other study ID # | 216 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | September 30, 2020 |
5-Fuorouracil (5-Fu) remains one of the most effective and most commonly used drugs to treat
colorectal cancer. Mucositis is a major complication that occurs in approximately 80% of
patients receiving 5-FU and results in abdominal bloating as well as vomiting and diarrhea.
oral mucositis (OM) are often very painful and compromise nutrition and oral hygiene as well
as increase risk for local and systemic infection.
OM is characterized by an intense inflammatory reaction on the mucosa lamina propria cells,
which results in activation of the transcription factor NF-kB. The activation of NF-kB leads
to transcription of genes involved in the synthesis of pro-inflammatory cytokines, such as
IL-1β, IL-6 and TNF-α. Agents known to attenuate the expression of cytokines have
demonstrated efficacy in the prevention of experimental mucositis.
The use of atorvastatin were associated with reduced production of TNF-α and IL-1β and
decreased neutrophil infiltration evidenced by histopathological analysis and Myeloperoxidase
(MPO) activity. In addition, atorvastatin also reduced oxidative stress and induced an
increase in non-protein sulfhydryl groups showing anti-inflammatory and immunomodulatory
action.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients (>18 years old). 2. Colon cancer patients ???? who will receive adjuvant FOLFOX 6& FOLFIRI 6 for 6 cycles. 3. ECOG performance status 0-2 4. Adequate bone marrow function (white blood count =4,000/mm3, platelet count =100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine <1.5 mg/dl). Exclusion Criteria: 1. Patients who have Clinical GIT mucositis or Periodontal disease. 2. Patients with other primary malignancy. 3. Patients receiving mTOR inhibitors (eg, rapamycin, everolimus, and temsirolimus), EGFR inhibitors (eg, bevacizumab and erlotinib) and tyrosine-kinase inhibitors (eg, sorafenib and sunitinib). 4. Hypersensitivity to Atorvastatin. 6-Pregnant and lactating women. 7- Patients treated with ATV for any other indication. 8- Patient who already have a mucositis |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Pharmacy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University | Nasser Institute For Research and Treatment |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of mucositis | screening the patients seeking mucositis & grading mucositis using Common Terminology Criteria for Adverse Events, CTCAE version 5 ( ranging from grade 1 of better outcome to 5 of worst outcome ) and evaluating the effect of atorvastatin on mucositis | 6 months | |
Secondary | grade of mucositis | the grade of mucositis will be assessed using common terminology criteria of adverse effects version 5 | 6 month | |
Secondary | Pain score | the pain due to mucositis will be assessed using visual analogue scale | 6 month | |
Secondary | Effect of mucositis on patient's daily life | The Oral Health Impact Pro?le-14 (OHIP-14) will be used to assess the effect of mucositis on the patients' liferanging from 0 of better outcome to 56 of worst outcome | 6-months | |
Secondary | liver function test | serum ALT and AST will be assessed before each cycle | 6 months | |
Secondary | serum levels of tumor necrosis factor a (TNF-a) | serum tumor necrosis factor a (TNF-a) will be assessed at baseline and after 6 months | 6 months |
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