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To determine radiation dermatitis severity reduction by prophylactic dressing in breast cancer patients who are receiving whole breast irradiation.

Assessment of reduction in severity of radiation dermatitis using prophylactic polyurethane film dressing in hypofractionated whole breast irradiation with simultaneous integrated boost using volumetric modulated arc therapy technique-an intrapatient randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044659
Enrollment
34
Registered
2022-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Polyurethane film dressing in one half of the breast: patients with breast cancer receiving hypofractionated whole breast irradiation with simultaneous integrated boost using volumetric

Sponsors

JIPMER
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 with simultaneous integrated boost technique.

Exclusion criteria

Exclusion criteria: 1. Active smoking status 2. Metastatic disease 3. Previous radiation to the ipsilateral breast 4. Flap reconstruction surgery 5. Active dermatitis 6. Any preexisting dermatological disorders 7. Treatment with topical or oral corticosteroids8. Mastectomy 9. Tattoos in the irradiation area

Design outcomes

Primary

MeasureTime frame
To determine the reduction in radiation dermatitis severity using CTCAE v.5 criteria, modified RISRAS and modified 10-point Catterall skin scoring profile for early breast cancer patients undergoing hypofractionated simultaneous integrated boost using VMAT by prophylactic polyurethane film dressing.Timepoint: At the last fraction of radiation and 4 weeks post radiation—

Secondary

MeasureTime frame
To assess the impact of skin disease on the quality of life using Dermatology Life Quality Index (DLQI) questionnaire.Timepoint: At the last fraction of radiation and 4 weeks post radiation—

Countries

India

Contacts

Public ContactDr Harish M

JIPMER

harishmadhubalan1996@gmail.com8825435540

Outcome results

None listed

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