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Impact of Tumor Bed Boost Technique on late effects after Breast Conservation Therapy

Impact of Tumor Bed Boost Technique on Toxicity and Aesthetic Outcomes after Breast Conservation Therapy: A Prospective Longitudinal Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/01/022871
Enrollment
260
Registered
2020-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

None listed

Sponsors

Tata Memorial Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Confirmed diagnosis of primary breast cancer (invasive or in situ) ii. Unilateral breast cancer. iii. Patient undergone breast conservation iv. Patient planned for adjuvant radiotherapy at TMC v. Patient planned whole breast RT and tumor bed boost vi. Patient consents for photographs of both breasts vii. Non-metastatic disease viii. Age > 18 years ix. Duration between last chemotherapy cycle and radiotherapy > 2 weeks x. Ability to give written informed consent after understanding the patient information sheet xi. Willing to comply to follow up visits and scheduled assessments at TMC

Exclusion criteria

Exclusion criteria: i. Reconstructive procedure not meriting tumor bed boost ii. Patient with breast conservation not planned for tumor bed boost iii. Patients receiving weekly adjuvant radiotherapy iv. Bilateral Breast Cancer v. Male vi. Mastectomy vii. Patients undergoing partial breast irradiation viii. Patients undergoing brachy boost ix. Nipple areola complex sacrificed during surgery and reconstruction not done x. Limited life expectancy due to comorbidities

Design outcomes

Primary

MeasureTime frame
To study the incidence of worsening of cosmetic outcomes in breast cancer patients receiving electron and photon boostTimepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy

Secondary

MeasureTime frame
To study factors affecting worsening of aesthetic outcome in women receiving electron and photon boost.Timepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy;To compare acute and 2-year toxicity in women receiving electron and photon boost.Timepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy;To correlate cosmetic outcome (both subjective and objective) with body image, breast pain and rib painscales of the EORTC-BR 23 quality of life.Timepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy;To study temporal trends in patient reported outcome with respect to aesthetic assessmentTimepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy;To validate the Body Image Scale in Indian breast cancer patientsTimepoint: -Before the start of Radiotherapy -End of Radiotherapy -6 months from end of Radiotherapy -12 months from end of Radiotherapy -24 months from end of Radiotherapy

Countries

India

Contacts

Public ContactDr Tabassum Wadasadawala

Tata Memorial Center, Mumbai

twadasadawala@actrec.gov.in02227405079

Outcome results

None listed

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