FindTrial
Sign In

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.

Topical corticosteroid in prevention of radiation dermatitis in breast cancer patients undergoing breast conservative treatment - an intrapatient randomized controlled trial. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065455
Enrollment
43
Registered
2024-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C502- Malignant neoplasm of upper-innerquadrant of breast Health Condition 2: C503- Malignant neoplasm of lower-innerquadrant of breast Health Condition 3: C504- Malignant neoplasm of upper-outerquadrant of breast Health Condition 4: C505- Malignant neoplasm of lower-outerquadrant of breast Health Condition 5: C501- Malignant neoplasm of central portion of breast

Interventions

Intervention1: Topical corticosteroid in half of the breast: Mometasone furoate 0.1% in patients with breast cancer receiving hypofractionated whole breast irradiation with simultaneous integrated boo

Sponsors

Dr Adapa Bindu Sai Sree
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Gunaseelan K

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

gunapgi@gmail.com9362966444

Outcome results

None listed

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