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Evaluation of the effect of topical German chamomile and Calendula officinalis ointment (Recubizol) in the prevention of capecitabine-induced hand–foot syndrome in patients with colon and breast cancer.

Evaluation of topical German Chamomile and Calendula officinalis ointment (Recubizul) in prevention of Capecitabine-related hand-foot syndrome in patients with colon and breast cancer: a randomized, double-blind clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151123025202N53
Enrollment
156
Registered
2026-05-14
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Condition 1: Colon Cancer. Condition 2: Breast Cancer. Malignant neoplasm of colon Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: Recubizol ointment (Nootech Pharm, Iran) will be applied to the surface of the hands and feet three times daily at a dose of 1 g per application (equivalent to two

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of colon or breast cancer Candidate for chemotherapy with capecitabine at a dose of =1000 mg/m² Willingness and consent to participate in the study.

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding History of allergic or anaphylactic reactions to chamomile or calendula Use of pyridoxine or renin–angiotensin system inhibitors (captopril or enalapril). Skin conditions affecting the hands or feet that could confound outcome assessment; Presence of grade =2 neuropathy Concurrent and continuous use of oral or topical NSAIDs or aspirin Serious medical or psychiatric conditions that may limit the patient’s ability to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
Incidence of chemotherapy-induced hand-foot syndrome. Timepoint: Once weekly from week 1 to week 12 after initiation of chemotherapy. Method of measurement: Clinical examination.

Secondary

MeasureTime frame
Changes in blood cell counts and renal and hepatic indices. Timepoint: Once weekly from week 1 to week 12 after initiation of chemotherapy. Method of measurement: Complete blood cell count (CBC), serum urea, creatinine, and liver function tests including AST, ALT, ALP, and bilirubin.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Moradi

Hamedan University of Medical Sciences

a.moradi@umsha.ac.ir+98 81 3838 0097

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026