Investigation of skin complications and cosmetic results of breast cancer treatment by Ultra hypofractionated IMRT method in early stage patients from 2023 to 2026 at Institute Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240112060693N1

Enrollment

Registered

2025-06-04

Start date

2025-06-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

breast cancer, radiotherapy , Ultrahypofraction radiotherapy. Malignant neoplasm of central portion of breast, female

Interventions

Intervention group:.

Eligibility

Sex/Gender

Female

Age

55 Years to No maximum

Inclusion criteria

Inclusion criteria: female more than 55 years old t3-1n0 lumpectomy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Determination of the rate of acute skin complications according to RTOG index and cosmetic results using BCTOS-12 and results of comparison of imaging with external observer with UHWBRT protocol with IMRT technique. Timepoint: After treatment, patients are assessed for acute skin toxicity and grade 1 and 2 scores are obtained. The BCTOS-12 questionnaire provides information at baseline, 6 months, 12 months, and 2 years after treatment. Method of measurement: BCTOS-12 Questionnaire: This questionnaire consists of 12 questions including breast shape, breast texture, elbow heaviness, nipple appearance, arm discomfort, elbow discomfort, breast tenderness, scar tissue, elbow swelling, breast swelling, underwear size, and breast sensitivity, with a 4-point scale (1 = no change to 4 = significant change).	—

Measure

Time frame

Determination of the rate of acute skin complications according to RTOG index and cosmetic results using BCTOS-12 and results of comparison of imaging with external observer with UHWBRT protocol with IMRT technique. Timepoint: After treatment, patients are assessed for acute skin toxicity and grade 1 and 2 scores are obtained. The BCTOS-12 questionnaire provides information at baseline, 6 months, 12 months, and 2 years after treatment. Method of measurement: BCTOS-12 Questionnaire: This questionnaire consists of 12 questions including breast shape, breast texture, elbow heaviness, nipple appearance, arm discomfort, elbow discomfort, breast tenderness, scar tissue, elbow swelling, breast swelling, underwear size, and breast sensitivity, with a 4-point scale (1 = no change to 4 = significant change).

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Secondary

Measure	Time frame
Sub-objectives of the project: 1- Comparison of BED2 and average dose to organs at risk with the UHWBRT protocol with the IMRT technique. Timepoint: The BED calculation is obtained immediately after the physics plan. Method of measurement: BED2 and the mean dose to organs at risk will be measured with two independent T tests. Hazard ratios will also be used to determine local recurrence and two-year survival.;Local recurrence rate in 2 years of UHWBRT protocol with IMRT technique. Timepoint: Follow-up of patients after 2 years. Method of measurement: Examination, mammography and ultrasound.	—

Measure

Time frame

Sub-objectives of the project: 1- Comparison of BED2 and average dose to organs at risk with the UHWBRT protocol with the IMRT technique. Timepoint: The BED calculation is obtained immediately after the physics plan. Method of measurement: BED2 and the mean dose to organs at risk will be measured with two independent T tests. Hazard ratios will also be used to determine local recurrence and two-year survival.;Local recurrence rate in 2 years of UHWBRT protocol with IMRT technique. Timepoint: Follow-up of patients after 2 years. Method of measurement: Examination, mammography and ultrasound.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contact???????? ????

Tehran University of Medical Sciences

arraee2008@gmail.com+98 21 6119 0000

Outcome results

None listed

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