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Effect of applying diclofenac cream for reducing radiation related skin effects in breast cancer patients receiving radiation treatments after surgery compared to applying vaseline gel.

Efficacy of Topical Diclofenac Cream in Reducing Radiation-Induced Dermatitis in Breast Cancer Patients Undergoing Post-operative Radiotherapy (PORT): A Phase 3 Randomized, Placebo Controlled Trial - DICLORAD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093383
Enrollment
108
Registered
2025-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast

Interventions

Intervention1: Diclofenac cream: Patients receiving adjuvant radiation therapy Will apply topical diclofenac 1% gel of quantity half teaspoon twice daily to the irradiated area morning and evening aft

Sponsors

Cancer Institute (WIA)
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactPriya Iyer

Cancer Institute (WIA)

priyaonc@gmail.com9498082772

Outcome results

None listed

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