Hand and Foot SyndromePhase 3HFSNCT05327751
Possible Protective Effect of Celecoxib Against Capecitabine Induced Hand and Foot Syndrome in Patients With Colorectal Cancer
A Phase 3 study testing Celecoxib 200mg and Capecitabine-based chemotherapy in people with Hand and Foot Syndrome and Erythrodysesthesia Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand and Foot Syndrome, Erythrodysesthesia Syndrome, HFS
- What is being tested?
- Celecoxib 200mg and Capecitabine-based chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old.
- Gender: Male and female.
- Newly diagnosed colorectal cancer patients who are scheduled to receive capecitabine-based chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Patients with adequate renal function (Sr. creatinine < 1.2 mg/dl or eGFR ≥ 90 ml/min).
- Patients with adequate hepatic function (Sr. bilirubin < 1.2 mg/dl).
Who cannot join
- Pregnant and lactating females.
- Patients with cardiovascular disease (congestive heart failure, cardiac arrhythmia, or coronary artery disease, …. etc.).
- History of H-Pylori infection.
- Patients with a known hypersensitivity to any of the used drugs.
- Patients with any contraindication to any of the used drugs.
Trial locations and contacts
1 site in 1 country.
Tarek Mohamed Mostafa, Professor of clinical pharmacy contact
About this study
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.
- Being tested
- Celecoxib 200mg, Capecitabine-based chemotherapy
- Keywords
- capecitapine induced hand and foot syndrome, Hand and Foot Syndrome, Erythrodysesthesia Syndrome, HFS, capecitabine based chemotherapy, Colorectal Cancer
- Medical subject headings
- Hand-Foot Syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200mgDrug
200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle.
Capecitabine-based chemotherapyDrug
Capecitabine-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib arm | Active comparator | 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. Receives: Drug: Celecoxib 200mg; Drug: Capecitabine-based chemotherapy |
| Control arm | Placebo comparator | This arm will include 22 patients who will receive 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks). Receives: Drug: Capecitabine-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After each cycle (each cycle is 21 days).
Secondary outcomes (3)
The change in serum levels of cyclooxygenase-2 (COX-2) enzyme.
The change in serum levels of cyclooxygenase-2 (COX-2) enzyme.
Measured: 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.
Measured: 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.
Measured: At basline and after the sixth cycle (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand and Foot SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Kettana, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327751
- Sponsor's protocol ID
- 42022
- Acronym
- HFS
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Protective Effect of Celecoxib Against Capecitabine Induced Hand and Foot Syndrome in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05327751
- Acronym / sponsor ID
- HFS / 42022
- Keywords
- capecitapine induced hand and foot syndrome, Hand and Foot Syndrome, Erythrodysesthesia Syndrome, HFS, capecitabine based chemotherapy, Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib arm | Active comparator | Drug: Celecoxib 200mg, Drug: Capecitabine-based chemotherapyThis 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. |
| Control arm | Placebo comparator | Drug: Capecitabine-based chemotherapyThis arm will include 22 patients who will receive 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-65 years old.
- Gender: Male and female.
- Newly diagnosed colorectal cancer patients who are scheduled to receive capecitabine-based chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Patients with adequate renal function (Sr. creatinine < 1.2 mg/dl or eGFR ≥ 90 ml/min).
Key exclusion criteria (5 listed)
- Pregnant and lactating females.
- Patients with cardiovascular disease (congestive heart failure, cardiac arrhythmia, or coronary artery disease, …. etc.).
- History of H-Pylori infection.
- Patients with a known hypersensitivity to any of the used drugs.
- Patients with any contraindication to any of the used drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib 200mg200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle. | Drug | Celecoxib arm |
| Capecitabine-based chemotherapyCapecitabine-based chemotherapy | Drug | Celecoxib arm, Control arm |
Primary outcome
The change in HFS grading.
Time frame: After each cycle (each cycle is 21 days).
The change in hand and foot syndrome (HFS) grading according to common terminology criteria of adverse events (CTCAE) version 5.0.
The change in HFS-specific QOL questionnaire (HFS-14).
Time frame: After each cycle (each cycle is 21 days).
Assessment of patients' quality of life using HFS-specific QOL questionnaire (HFS-14) based on patients' symptoms.
3 secondary outcomes
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).
Time frame: At basline and after the sixth cycle (each cycle is 21 days).
The change in serum levels of malondialdehyde (MDA).
Time frame: At basline and after the sixth cycle (each cycle is 21 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Related trials for Hand and Foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
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SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
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Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
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Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Mohamed Mostafa, Professor of clinical pharmacy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib 200mg and Capecitabine-based chemotherapy in people with Hand and Foot Syndrome and Erythrodysesthesia Syndrome, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Kettana (+201009241434, ahmed150848@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in HFS grading. (time frame: After each cycle (each cycle is 21 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.