A study to see the effect of using a steroid cream on the skin of the breast during radiation therapy to the whole breast in preventing radiation induced skin reactions in breast cancer patients undergoing breast conservative treatment.
Not Applicable
- Conditions
- Health Condition 1: C501- Malignant neoplasm of central portion of breastHealth Condition 2: C503- Malignant neoplasm of lower-innerquadrant of breastHealth Condition 3: C505- Malignant neoplasm of lower-outerquadrant of breastHealth Condition 4: C502- Malignant neoplasm of upper-innerquadrant of breastHealth Condition 5: C504- Malignant neoplasm of upper-outerquadrant of breast
- Registration Number
- CTRI/2024/04/065455
- Lead Sponsor
- Dr Adapa Bindu Sai Sree
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Above 18 years of age
2.Breast-conservative surgery for breast cancer
3.A hypofractionation regimen of 40.5Gy in 15 fractions (fx) with simultaneous integrated boost technique.
Exclusion Criteria
1.Hypersensitivity to mometasone furoate
2.Bilateral breast carcinoma
3.Patients receiving leukotriene inhibitors
4.Patients on steroids for chronic conditions
5.Active dermatitis
6.Any preexisting dermatological disorder
7.Tattoos in the irradiation area
8.Previous radiation to ipsilateral breast
9.Metastatic disease
10.Active smoking status
11.Pre-existing skin breakdown within the planned radiotherapy field at the time of study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the incidence and time to onset of grade 2 or more radiation dermatitis using CTCAE v5.0 criteria and score 3 or more pain score as assessed by the visual analogue scale (VAS)Timepoint: weekly,at the last fraction of radiation and 4 weeks post radiation
- Secondary Outcome Measures
Name Time Method To assess skin toxicity on quality of life as measured by Radiation Induced Skin Reactions Assessment score(RISRAS) and Dermatology life quality index questionnaire (DLQI)Timepoint: weekly,at the last fraction of radiation and 4 weeks post radiation