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Evaluation of topical Piroxicam in prevention of Capecitabine-related hand-foot syndrome

Evaluation of topical Piroxicam in prevention of Capecitabine-related hand-foot syndrome in patients with colon and breast cancer: a randomized, double-blind clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241117063744N1
Enrollment
140
Registered
2024-12-09
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: breast cancer. Condition 2: colon cancer. Malignant neoplasm of breast Malignant neoplasm of colon

Interventions

Intervention 1: Intervention group: Intervention group: In the intervention group, piroxicam gel (0.5%, Sobhan Pharmaceuticals, Iran) will be used twice daily, 1 gram = two fingertip units (FTU) each

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Stage 2 and 3 colon cancer patients Triple-negative breast cancer patients with residual disease after surgery

Exclusion criteria

Exclusion criteria: Presence of grade 2 or higher neuropathy skin conditions that, in the opinion of the physician, may affect the hands or feet or complicate assessment during the study period Use of pyridoxine or renin-angiotensin system inhibitors History of hypersensitivity or anaphylactic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) History of asthma or other allergic-type reactions after taking aspirin or other NSAIDs Patients taking oral or topical NSAIDs or aspirin for other conditions Concomitant illnesses, including severe infections, that may compromise the patient's ability to safely perform the procedures specified in this protocol Serious medical or psychiatric conditions that may limit the patient's ability to adhere to the protocolDiscontinuation of medication or placebo during the treatment period Unwillingness to continue in the study at any stage

Design outcomes

Primary

MeasureTime frame
Grade 2 and above hand-foot syndrome. Timepoint: Patients will be assessed by a cancer specialist for the occurrence of HFS at the beginning of chemotherapy and at the end of each chemotherapy cycle based on the World Health Organization HFS assessment scale (WHO score) for 4 cycles. Method of measurement: World Health Organization HFS Assessment Scale (WHO Scoring).

Secondary

MeasureTime frame
When does hand-foot syndrome occur?. Timepoint: After 4 cycles of capecitabine treatment. Method of measurement: Hand-foot syndrome related quality of life questionnaire number 14(HFS-14).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Darvishi

Shahid Beheshti University of Medical Sciences

Ahdarvishi.1992@gmail.com+98 21 6650 4054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026