Evaluation of the effects of a lotion containing Althaea officinalis, Ocimum basilicum, and Apium graveolensin extracts in the prevention and treatment of radiation therapy-induced dermatitis in breast cancer patients

Evaluation of the effects of a lotion containing Althaea officinalis, Ocimum basilicum, and Apium graveolensin extracts in the prevention and treatment of radiation therapy-induced dermatitis in breast cancer patients: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160131026282N2

Enrollment

Registered

2023-09-14

Start date

2023-10-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Radiation therapy-induced dermatitis in breast cancer patients. Radiodermatitis

Interventions

Intervention group: A standardized herbal lotion is applied on the affected area twice a day at least 2 hours before and after radiation therapy. The patients are requested not to wear cloth before

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: patients (women) >18 years, undergone breast Lumpectomy surgery for breast cancer and a fractionation regimen of at least 42 Gy. Patients capable of finishing radiotherapy and contributing to the research team. The patient is personally capable of lotion application and learning the research instructions. Patient who have not undergone radiotherapy previously.

Exclusion criteria

Exclusion criteria: Patients with ulcers or unhealed wounds, burns, infections, and previous skin complications at the radiotherapy site. Patients who undergo chemotherapy or hormone therapy (adjuvant or neoadjuvant) at the same time Using skin medicines to treat skin diseases other than dermatitis caused by radiation therapy Patients taking high-dose non-steroidal anti-inflammatory drugs. Presence of connective tissue disorders or collagen disorders Allergy to the herbs used in the intervention lotion or any of the components of the formulation Allergy to the routine treatment used in the treatment of dermatitis underlying disease such as diabetes Smoking Taking radiation sensitizing drugs

Design outcomes

Primary

Measure	Time frame
The severity of the radiation therapy-induced dermatitis. Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: RTOG/EORTC toxicity criteria.;Evaluating the severity of dermatitis symptoms (level of pain, itchiness and burning as well as the effect on day to day life). Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: The radiation-induced skin reaction assessment scale (RISRAS).	—

Measure

Time frame

The severity of the radiation therapy-induced dermatitis. Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: RTOG/EORTC toxicity criteria.;Evaluating the severity of dermatitis symptoms (level of pain, itchiness and burning as well as the effect on day to day life). Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: The radiation-induced skin reaction assessment scale (RISRAS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehjat

Mashhad University of Medical Sciences

Javadib@mums.ac.ir+98 51 3180 1268

Outcome results

None listed

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