An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)

Breast Cancer Clinical Trial

— STARLINGS  

Official title:

An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05263362
• Other study ID #: MEC-2021-0829
• Status: Enrolling by invitation
• Start date: April 11, 2022
• Est. completion date: September 20, 2025

Study information

• Verified date: June 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.

Description:

The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 750
• Est. completion date: September 20, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients aged = 18 years

• History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.

• Operated between 1st of January 2016 and 31th of December 2020

• Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost

• Adequate understanding of the Dutch language and written informed consent

Exclusion Criteria:

• Any breast surgery or re-irradiation on the breast area after BCT

• Progression of disease (and additional treatment) since BCT

• Patients who received partial breast irradiation

• Current pregnancy or breast feeding

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Carcinoma
• Breast Carcinoma in Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Fibrosis

Intervention

Other:
• no intervention
At one timepoint patients will get physical examination of the breasts, medical photographs will be taken, and they will fill in five questionnaires about satisfaction of the breasts, quality of life and general health.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Maasstad hospital	Rotterdam
Netherlands	Franciscus Gasthuis & Vlietland	Schiedam

Sponsors (5)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert Schweitzer hospital, Dordrecht, the Netherlands, Franciscus Gasthuis and Vlietland Hospital, Rotterdam and Schiedam, the Netherlands, Maasstad hospital, Rotterdam, the Netherlands, Stichting BeterKeten, the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis of the breast as measured by CTCAE v5 scale	Fibrosis will be graded by the researcher using the CTCAE v5 scale.; On the CTCAE scale of superficial soft tissue fibrosis: Grade 0 = no fibrosis, Grade 1 = mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up), Grade 2 = Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL, Grade 3 = Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self care ADL, Grade 4 = Generalized; associated with signs or symptoms of impaired breathing or feeding, Grade 5 = Death.; We are planning to score fibrosis of the breast as none/mild (grade 0-1) or moderate/severe (grade 2-3).	2-6 years after breast conserving treatment. 1 point of measurement.
Primary	Cosmetic outcome as measured by 9-item questionnaire	Cosmetic outcome will be evaluated by means of a 9-item cosmetic patient questionnaire filled out by the patient with scoring on a four point scale (range from 'excellent' to 'poor' per item).	2-6 years after breast conserving treatment. 1 point of measurement.
Primary	Cosmetic outcome as measured by BCCT.core software	Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC, the Faculdade de Medicina da Universidade do Porto) cosmetic outcome will be assessed.	2-6 years after breast conserving treatment. 1 point of measurement.
Secondary	Quality of life, as measured by BREAST-Q	Which includes the following domains: psychosocial well being, sexual well being, satisfaction with the breasts, physical well being, adverse effects of radiation.; All domains are scored 0 to 100 points, higher points means a better outcome.	2-6 years after breast conserving treatment. 1 point of measurement.
Secondary	Quality of life, as measured by EORTC Quality of Life Questionnaires-C30	Which include functional domains, global health status and symptom scales.; For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms.	2-6 years after breast conserving treatment. 1 point of measurement.
Secondary	Quality of life, as measured by EORTC Quality of Life Questionnaires-B23	Which include functional domains, global health status and symptom scales.; For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms.	2-6 years after breast conserving treatment. 1 point of measurement.
Secondary	Quality of life, as measured by EQ-5D-5L - five dimensions	The EQ-5D-5L include five questions about five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression.; For each dimension, participants choose one of five levels that best fits their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555).	2-6 years after breast conserving treatment. 1 point of measurement.
Secondary	Quality of life, as measured by EQ-5D-5L - VAS	The EQ-5D-5L include, apart from the five questions about five dimensions (see above), a visual analogue scale (VAS).; The VAS provides rating of the participant's health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').	2-6 years after breast conserving treatment. 1 point of measurement.