Health Condition 1: C50-C50- Malignant neoplasms of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients aged 18 years and above. 2.Histologically confirmed breast cancer treated with mastectomy or breast conservation surgery 3.Planned for adjuvant PORT (conventional fractionation or hypofractionation). 4.Eastern Cooperative Oncology Group (ECOG) performance status 0?2. 5.Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.re-existing dermatological conditions affecting the chest wall. 2.Known allergy or hypersensitivity to diclofenac, petroleum jelly, or NSAIDs. 3.Concurrent use of other topical agents on the radiation field. 4.History of poor compliance or psychiatric illness precluding informed consent. 5.Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of more than equal to grade 2 RID is 80% in comparator arm and will reduce to 50% in the intervention armTimepoint: Baseline, every week upto completion of RT and 2 weeks after RT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported symptom burden of RID, measured using the Visual Analogue Scale (VAS) (0?10) for burning, pain, erythema, and pruritus, assessed weekly during radiotherapy and at 2-week post-treatment follow-up. Outcome will be summarized as mean weekly VAS scores.Timepoint: Two weeks after completion of RT | — |
Countries
India
Contacts
Cancer Institute (WIA)