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Hand-Foot Syndrome

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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.

This arm will include 22 patients who will receive 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks).

200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle.

Celecoxib 200mg

Capecitabine-based chemotherapy

Ahmed Mohamed Kettana

Tarek Mohamed Mostafa, Professor of clinical pharmacy

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.

Possible Protective Effect of Celecoxib Against Capecitabine Induced Hand and Foot Syndrome in Patients With Colorectal Cancer

The change in hand and foot syndrome (HFS) grading according to common terminology criteria of adverse events (CTCAE) version 5.0.

Assessment of patients' quality of life using HFS-specific QOL questionnaire (HFS-14) based on patients' symptoms.

The change in serum levels of cyclooxygenase-2 (COX-2) enzyme.

The change in serum levels of tumor necrosis factor alpha (TNF-α) as a inflammatory marker.

The change in serum levels of malondialdehyde (MDA) as oxidative stress marker.

Tanta University

clinical pharmacist

Breast Neoplasms

Colonic Neoplasms

Herbal and Botanical

Eniluracil

Cola

William P. Petros, Pharm D

A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).

Primary Objectives

1. To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
2. To assess any eniluracil dose response relationship in prevention of HFS.
3. To evaluate any potential toxicity of eniluracil ointment.

Eniluracil Hand Foot Syndrome

A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)

West Virginia University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Possible Protective Effect of Celecoxib Against Capecitabine Induced Hand and Foot Syndrome in Patients With Colorectal Cancer	NCT05327751	Hand and Foot S... Erythrodysesthe... HFS Colorectal Canc...	Celecoxib 200mg Capecitabine-ba...	18 Years - 65 Years	Tanta University
Eniluracil Hand Foot Syndrome	NCT00827580	Breast Cancer Colon Cancer	Eniluracil	18 Years -	West Virginia University
Eniluracil Hand Foot Syndrome	NCT00827580	Breast Cancer Colon Cancer	Eniluracil	18 Years -	West Virginia University

Spots Global Cancer Trial Database for hfs

Every month we try and update this database with for hfs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hfs

Every month we try and update this database with for hfs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hfs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.