A Phase 3 interventional study of Celecoxib 200mg and Capecitabine-based chemotherapy in Hand and Foot Syndrome, Erythrodysesthesia Syndrome and HFS, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Tanta University · Phase 3, Interventional, and Prevention
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of malignancy-related mortality. Capecitabine has been approved for the treatment of colorectal cancer as first-line therapy. About 50%-68% of patients who take capecitabine develop Hand-foot syndrome. Hand-foot syndrome (HFS) is the most common adverse event of capecitabine-based chemotherapy. Initial symptoms of HFS are dysesthesia, tingling in the palms, fingers, and soles of the feet, and erythema, which may progress to an extremely painful and debilitating condition without prompt management. These symptoms can potentially lead to a worsened quality of life in patients taking capecitabine-based chemotherapy. Moreover, the adverse reaction necessitates dose-reduction or withdrawal of the chemotherapeutic agent. The mechanisms of HFS are still unknown, and there are limited data available on how to prevent them or manage them. However, different hypotheses of capecitabine-induced HFS pathogenesis have been suggested. One of the hypotheses stated that HFS is a kind of inflammation mediated by cyclooxygenase's (COX-2) over expression in palm and feet by capecitabine and its metabolites causing elevation of inflammatory markers as tumor necrosis factor alpha (TNF-α). COX-2 enzyme plays a main role in inflammation and pain. Therefore, celecoxib which is selective (COX-2) inhibitor may have a key role in the HFS treatment plan. A retrospective study and two prospective studies showed that combining capecitabine with celecoxib, a selective COX-2 inhibitor, can significantly reduce capecitabine-related HFS in colorectal cancer patients. Those studies were dependent on HFS grading only without measuring any markers. So, in our study we assess possible protective effect of celecoxib against capecitabine induced HFS and measure inflammatory marker as tumor necrosis factor alpha (TNF-α), oxidative stress marker as Malondialdehyde (MDA), and cyclooxygenase-2 (COX-2) enzyme to show whether capecitabine induced HFS is caused by COX-2 mediated inflammation or not.
47 studies on the registry are indexed under Hand-Foot Syndrome; 10 are open to participants now.
This study's planned enrollment of 44 is below the median of 58 across 38 interventional studies indexed under Hand-Foot Syndrome.
Browse Hand-Foot Syndrome studies →Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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This arm will include 22 patients who will receive 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks) in addition to 200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle. The study duration will be the duration of the 6 cycles.
Drug: Celecoxib 200mg · Drug: Capecitabine-based chemotherapy
This arm will include 22 patients who will receive 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks).
Drug: Capecitabine-based chemotherapy
200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle.
Capecitabine-based chemotherapy
The change in HFS grading.
The change in hand and foot syndrome (HFS) grading according to common terminology criteria of adverse events (CTCAE) version 5.0.
Time frame: After each cycle (each cycle is 21 days).
The change in HFS-specific QOL questionnaire (HFS-14).
Assessment of patients' quality of life using HFS-specific QOL questionnaire (HFS-14) based on patients' symptoms.
Time frame: After each cycle (each cycle is 21 days).
The change in serum levels of cyclooxygenase-2 (COX-2) enzyme.
The change in serum levels of cyclooxygenase-2 (COX-2) enzyme.
Time frame: At basline and after the sixth cycle (each cycle is 21 days).
The change in serum levels of tumor necrosis factor alpha (TNF-α).
The change in serum levels of tumor necrosis factor alpha (TNF-α) as a inflammatory marker.
Time frame: At basline and after the sixth cycle (each cycle is 21 days).
The change in serum levels of malondialdehyde (MDA).
The change in serum levels of malondialdehyde (MDA) as oxidative stress marker.
Time frame: At basline and after the sixth cycle (each cycle is 21 days).
Started Apr 2022 (actual). Primary completion is estimated for Apr 2024, 24 months after the start.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Celecoxib