Investigation of the efficacy of a herbal topical gel in reducing the skin reactions in cancer patients taking chemotherapy drugs Fluoropyrimidines induced Hand-Foot Syndrome in cancerous patients

Investigation of the efficacy of a topical dosage form consisting lawsonia inermis extracts in reducing Fluoropyrimidines induced Hand-Foot Syndrome in cancerous patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014051017643N1

Enrollment

Registered

2015-08-27

Start date

2014-06-11

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

hand-foot syndrome. localized skin eruption due to drugs and medicaments

Interventions

Intervention 1: The topical gel will be administrated to the foot or hand of the patients randomly four times a day for two weeks. Intervention 2: The topical placebo will be administrated to the foot

Treatment - Drugs

Placebo

The topical gel will be administrated to the foot or hand of the patients randomly four times a day for two weeks

The topical placebo will be administrated to the foot or hand of the patients taking the topical drug randomly four times a day for two weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Taking 5-fluorouracil (5-fu) by injection or oraly Capecitabine as an anticancer drug; showing hand-foot syndrome; patient satisfaction; Having cancer. Exclusion criteria: Treatment change and discontinuing 5-fluorouracil (5-fu) and oral Capecitabine administration; Showing no hand-foot syndrome; Patient's death; Lack of cancer; Sensitivity to compounds of formula.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of HFS symptoms. Timepoint: Beginning of the study , the fourteenth day. Method of measurement: NCI Hand-Foot Syndrome staging version 4.0.	—

Secondary

Measure	Time frame
Skin Sensitivity. Timepoint: From the beginning of the study. Method of measurement: Observational.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRazieh Mohajerani

Iislamic Azad University Of Pharmaceutical Sciences Branch

mohajerani.razieh@yahoo.com+98 21 2264 0051

Outcome results

None listed

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