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

Early Phase 1

Conditions: Radiation therapy-induced dermatitis in breast cancer patients.
Radiodermatitis

Registration Number: IRCT20160131026282N2

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 72

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures