Colorectal CancerDICLO-HFSNCT07177560
Topical Diclofenac for Hand-Foot Syndrome Prevention in Colorectal and Gastric Cancer on Capecitabine (DICLO-HFS)
An observational study of Colorectal Cancer and Gastric Cancer (GC), run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
Hand-foot syndrome (HFS) is a frequent adverse effect of capecitabine, presenting with redness, swelling, pain, and peeling of the skin on the palms and soles. These symptoms may impair daily activities and lead to treatment modifications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer (GC), Capecitabine
- How many people
- 151 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 28 Feb 2024
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) with histologically confirmed colorectal (colon or rectal) or gastric cancer who were initiating capecitabine-based therapy at two tertiary oncology centers in Ankara, Turkey (Gazi University; Ankara Etlik City Hospital). Patients were enrolled consecutively at treatment start and managed per treating physician practice into two observational cohorts: prophylactic 1% topical diclofenac gel vs active monitoring without prophylaxis. No prior systemic chemotherapy; weekly clinic assessments during therapy.
Who may be able to join
- Age ≥18 years.
- Histologically or cytologically confirmed colorectal or gastric cancer.
- Planned capecitabine-based therapy (monotherapy or capecitabine plus oxaliplatin).
- Planned starting capecitabine dose ≥2,000 mg/m²/day.
- No prior systemic chemotherapy for the current malignancy.
- Ability and willingness to attend weekly clinical assessments during treatment.
- Written informed consent obtained.
Who cannot join
- Pre-existing dermatologic conditions affecting hands/feet (e.g., eczema, psoriasis) or peripheral neuropathy.
- Sjögren's syndrome involving hands or feet.
- Current or planned systemic NSAID use during capecitabine therapy.
- Use of other HFS prophylaxis at baseline (e.g., topical NSAIDs other than diclofenac, pyridoxine).
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., history of asthma, urticaria, allergic reactions).
- Planned initial capecitabine dose <2,000 mg/m²/day.
- Anticipated inability to comply with weekly follow-up assessments.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Etlik City Hospital
Ankara
Gazi University
Ankara
About this study
Official title: Prospective Observational Study Assessing the Prophylactic Effect of Topical Diclofenac on Hand-Foot Syndrome in Patients With Colorectal and Gastric Cancer Receiving Capecitabine
Hand-foot syndrome (HFS) is a frequent adverse effect of capecitabine, presenting with redness, swelling, pain, and peeling of the skin on the palms and soles. These symptoms may impair daily activities and lead to treatment modifications.
This prospective observational study is being conducted at two tertiary oncology centers in Turkey to evaluate whether prophylactic use of topical diclofenac gel can prevent or delay the development of HFS in patients receiving capecitabine for colorectal or gastric cancer. Approximately 150 patients are enrolled and managed according to physician preference. Patients either receive topical diclofenac gel (applied twice daily to the hands and feet) or are followed with active monitoring.
The primary objective is to assess the incidence of grade 2 or 3 HFS. Secondary objectives include time to onset of HFS and the frequency of capecitabine dose reductions related to HFS.
Read the detailed description
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common dermatologic toxicity of fluoropyrimidine chemotherapy such as capecitabine. Clinically significant HFS (grade ≥2) can negatively impact treatment adherence and quality of life by necessitating dose interruptions or reductions. The underlying mechanisms are not fully understood, but inflammatory pathways, including cyclooxygenase-2 (COX-2) signaling, are thought to contribute.
Preventive strategies for HFS remain limited. Celecoxib, a systemic COX-2 inhibitor, has been shown to reduce HFS incidence but is not widely adopted due to safety concerns. Topical diclofenac gel, a locally acting nonsteroidal anti-inflammatory drug (NSAID), represents a potential low-toxicity prophylactic approach.
This prospective, multicenter observational study is designed to evaluate the prophylactic effect of topical diclofenac in patients with colorectal or gastric cancer initiating capecitabine therapy. The study is conducted at Gazi University Faculty of Medicine and Ankara Etlik City Hospital. Eligible participants are adults scheduled to receive capecitabine-based therapy who have not received prior chemotherapy.
Participants are managed according to physician preference:
Topical diclofenac group: Patients apply 1% topical diclofenac gel to clean, dry skin on the hands and feet twice daily during capecitabine treatment.
Observation group: Patients are followed with active monitoring without prophylactic intervention.
The primary endpoint is the incidence of grade 2 or 3 HFS, assessed weekly using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary endpoints include time to onset of HFS and the proportion of patients requiring capecitabine dose reductions due to HFS.
The planned enrollment is approximately 150 patients, with follow-up continuing until either the onset of clinically significant HFS or completion of capecitabine therapy.
- Keywords
- Hand-Foot Syndrome, Capecitabine, Topical Diclofenac, Chemotherapy Toxicity, Supportive Care
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Topical Diclofenac | Patients with colorectal or gastric cancer receiving capecitabine who applied 1% topical diclofenac gel to the hands and feet twice daily throughout treatment. This group was managed according to physician preference and assessed weekly for the development of hand-foot syndrome (HFS). | |
| Observation | Patients with colorectal or gastric cancer receiving capecitabine who were actively monitored without prophylactic topical treatment. These patients were assessed weekly for the development of hand-foot syndrome (HFS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥2 hand-foot syndrome (HFS)
Proportion of participants who develop grade ≥2 HFS during capecitabine therapy. HFS will be assessed weekly by oncology clinicians using the Common Terminology Criteria for Adverse Events (CTCAE). Numerator: participants with grade ≥2 HFS; Denominator: all enrolled participants.
Measured: Up to 24 weeks (from first capecitabine dose through study completion)
Secondary outcomes (1)
Time to onset of grade ≥2 hand-foot syndrome (HFS)
Time (weeks) from the first capecitabine dose to the first documentation of grade ≥2 HFS per CTCAE. Participants without the event will be censored at end of treatment or end of follow-up.
Measured: Up to 24 weeks (baseline to first event or end of study follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Jul 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhun Akdoğan, Gazi University
- Investigators
- Nuriye Ozdemir, MD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177560
- Sponsor's protocol ID
- AESH-EKI-0022
- Other IDs
- 0022
- Acronym
- DICLO-HFS
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akdogan O, Yucel SE, Yazici O, Yucel KB, Gurler F, Uyar GC, Savas G, Yesilbas E, Coskun U, Baskurt K, Uner A, Ozet A, Oksuzoglu B, Ozdemir N, Sutcuoglu O. Topical Diclofenac for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Prospective Real-World Study. JCO Glob Oncol. 2026 Aug;12(8):e2600151. doi: 10.1200/GO-26-00151. Epub 2026 Aug 20.
PubMed 42623594
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Assessing the Prophylactic Effect of Topical Diclofenac on Hand-Foot Syndrome in Patients With Colorectal and Gastric Cancer Receiving Capecitabine
- ClinicalTrials.gov ID
- NCT07177560
- Acronym / sponsor ID
- DICLO-HFS / AESH-EKI-0022
- Keywords
- Hand-Foot Syndrome, Capecitabine, Topical Diclofenac, Chemotherapy Toxicity, Supportive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Sep 2025 (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.
Hand-foot syndrome (HFS) is a frequent adverse effect of capecitabine, presenting with redness, swelling, pain, and peeling of the skin on the palms and soles. These symptoms may impair daily activities and lead to treatment modifications.
This prospective observational study is being conducted at two tertiary oncology centers in Turkey to evaluate whether prophylactic use of topical diclofenac gel can prevent or delay the development of HFS in patients receiving capecitabine for colorectal or gastric cancer. Approximately 150 patients are enrolled and managed according to physician preference. Patients either receive topical diclofenac gel (applied twice daily to the hands and feet) or are followed with active monitoring.
The primary objective is to assess the incidence of grade 2 or 3 HFS. Secondary objectives include time to onset of HFS and the frequency of capecitabine dose reductions related to HFS.
Detailed description
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common dermatologic toxicity of fluoropyrimidine chemotherapy such as capecitabine. Clinically significant HFS (grade ≥2) can negatively impact treatment adherence and quality of life by necessitating dose interruptions or reductions. The underlying mechanisms are not fully understood, but inflammatory pathways, including cyclooxygenase-2 (COX-2) signaling, are thought to contribute.
Preventive strategies for HFS remain limited. Celecoxib, a systemic COX-2 inhibitor, has been shown to reduce HFS incidence but is not widely adopted due to safety concerns. Topical diclofenac gel, a locally acting nonsteroidal anti-inflammatory drug (NSAID), represents a potential low-toxicity prophylactic approach.
This prospective, multicenter observational study is designed to evaluate the prophylactic effect of topical diclofenac in patients with colorectal or gastric cancer initiating capecitabine therapy. The study is conducted at Gazi University Faculty of Medicine and Ankara Etlik City Hospital. Eligible participants are adults scheduled to receive capecitabine-based therapy who have not received prior chemotherapy.
Participants are managed according to physician preference:
Topical diclofenac group: Patients apply 1% topical diclofenac gel to clean, dry skin on the hands and feet twice daily during capecitabine treatment.
Observation group: Patients are followed with active monitoring without prophylactic intervention.
The primary endpoint is the incidence of grade 2 or 3 HFS, assessed weekly using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary endpoints include time to onset of HFS and the proportion of patients requiring capecitabine dose reductions due to HFS.
The planned enrollment is approximately 150 patients, with follow-up continuing until either the onset of clinically significant HFS or completion of capecitabine therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Diclofenac | – | –Patients with colorectal or gastric cancer receiving capecitabine who applied 1% topical diclofenac gel to the hands and feet twice daily throughout treatment. This group was managed according to physician preference and assessed weekly for the development of hand-foot syndrome (HFS). |
| Observation | – | –Patients with colorectal or gastric cancer receiving capecitabine who were actively monitored without prophylactic topical treatment. These patients were assessed weekly for the development of hand-foot syndrome (HFS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with histologically confirmed colorectal (colon or rectal) or gastric cancer who were initiating capecitabine-based therapy at two tertiary oncology centers in Ankara, Turkey (Gazi University; Ankara Etlik City Hospital). Patients were enrolled consecutively at treatment start and managed per treating physician practice into two observational cohorts: prophylactic 1% topical diclofenac gel vs active monitoring without prophylaxis. No prior systemic chemotherapy; weekly clinic assessments during therapy.
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed colorectal or gastric cancer.
- Planned capecitabine-based therapy (monotherapy or capecitabine plus oxaliplatin).
- Planned starting capecitabine dose ≥2,000 mg/m²/day.
- No prior systemic chemotherapy for the current malignancy.
Key exclusion criteria (7 listed)
- Pre-existing dermatologic conditions affecting hands/feet (e.g., eczema, psoriasis) or peripheral neuropathy.
- Sjögren's syndrome involving hands or feet.
- Current or planned systemic NSAID use during capecitabine therapy.
- Use of other HFS prophylaxis at baseline (e.g., topical NSAIDs other than diclofenac, pyridoxine).
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., history of asthma, urticaria, allergic reactions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of grade ≥2 hand-foot syndrome (HFS)
Time frame: Up to 24 weeks (from first capecitabine dose through study completion)
Proportion of participants who develop grade ≥2 HFS during capecitabine therapy. HFS will be assessed weekly by oncology clinicians using the Common Terminology Criteria for Adverse Events (CTCAE). Numerator: participants with grade ≥2 HFS; Denominator: all enrolled participants.
1 secondary outcome
Time to onset of grade ≥2 hand-foot syndrome (HFS)
Time frame: Up to 24 weeks (baseline to first event or end of study follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 42623594Akdogan O, Yucel SE, Yazici O, Yucel KB, Gurler F, Uyar GC, Savas G, Yesilbas E, Coskun U, Baskurt K, Uner A, Ozet A, Oksuzoglu B, Ozdemir N, Sutcuoglu O. Topical Diclofenac for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Prospective Real-World Study. JCO Glob Oncol. 2026 Aug;12(8):e2600151. doi: 10.1200/GO-26-00151. Epub 2026 Aug 20.
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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.
Nuriye Ozdemir, MD study chair
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Gastric Cancer (GC), run by Gazi University at 2 sites in Turkey (Türkiye).
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥2 hand-foot syndrome (HFS) (time frame: Up to 24 weeks (from first capecitabine dose through study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07177560, which also lists 1 linked publication.
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 17 Sep 2025.