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Investigating the effect of violet oil and sweet almond oil on Capecitabine-induced hand-foot syndrome

Investigation of the therapeutic effects of violet oil and sweet Almond oil versus placebo on Capecitabine-induced hand-foot syndrome in non-metastatic cancer patients: a multicenter study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250124064505N1
Enrollment
120
Registered
2025-04-28
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Capecitabine-induced Dermatitis. Drug-induced dermatitis

Interventions

Intervention 1: Group (1) Intervention: Patients with dermatitis will apply a topical medication consisting of violet oil in a sweet almond base daily for one month, using it in two doses (morning and

Sponsors

Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Consent to Participate in the Study, Mental and Psychological Health, Patients with Cancer Undergoing Treatment with Capecitabine, Diagnosis of Anatomopathological Malignancies of Solid Organs, No Metastasis at the Time of Diagnosis, Age Range 18 to 65 Years, No Likely Use of Violet Oil, Topical Almond Oil, upon Entry into the Study, No Skin Diseases Including Lupus, Scleroderma, and Active Psoriasis, No Underlying Allergies, Diabetes, or Chronic Kidney Diseases No Use of Tobacco, Drugs, or Alcohol

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Dermatitis. Timepoint: Zero day (the day before the intervention starts), days 15 and 30 after intervention, and two weeks after the end of the intervention. Method of measurement: CTCAE v5.0 form.

Secondary

MeasureTime frame
Pruritis. Timepoint: Zero day (the day before the intervention starts), days 15 and 30 after intervention, and two weeks after the end of the intervention. Method of measurement: self-report.;Quality of life. Timepoint: Zero day (beginning of the study) and day 30 (end of the study). Method of measurement: DLQI questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Ghanbarzadeh

Sabzevar University of Medical Sciences

ghanbarzadehmr1@mums.ac.ir+98 51 4422 9081

Outcome results

None listed

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