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A prospective randomized controlled clinical study to evaluate the effect of thymus preservation on lymphopenia induced by adjuvant radiotherapy after breast cancer surgery

A prospective randomized controlled clinical study to evaluate the effect of thymus preservation on lymphopenia induced by adjuvant radiotherapy after breast cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080484
Enrollment
Unknown
Registered
2024-01-30
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Breast cancer

Interventions

Thymus protection group:The thymus is delineated in the target area of adjuvant radiotherapy patients after breast cancer surgery, and the dose volume is limited.
Control group:Do not delineate the thymus as an organ at risk

Sponsors

The Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.1 Females aged 18-75 years; 1.2 Breast cancer patients with pathological diagnosis requiring postoperative adjuvant radiotherapy; 1.3 The hematopoietic function and liver, kidney, heart and lung function of the patient are acceptable, (white blood cell > 2.5*109/L, platelet > 50*109/L, bilirubin not more than 1.5 times the upper limit of normal, liver function alanine aminotransferase and aspartate aminotransferase not more than 2.5 times the upper limit of normal, and renal function creatinine not more than 1.5 times the upper limit of normal); 1.4 The patient activity status score was 0-1 points based on the Eastern Cooperative Oncology Group (ECOG) score method, and the functional status evaluation score was =70 points by the Karnofsky (KPS) score method. 1.5 All of them have indications for postoperative radiotherapy and chemotherapy, and have not yet undergone a full course of radiotherapy; 1.6 No distant metastases occurred at the time of diagnosis; 1.7 Able to sign written informed consent by the patient himself/herself.

Exclusion criteria

Exclusion criteria: 2.1Patients with bilateral breast cancer; 2.2 Radiotherapy at all doses has been completed; 2.3 Presence of a second primary tumor; 2.4 Pregnant and lactating women; 2.5 presence of distant metastases; 2.6 Male breast cancer patients; 2.7 Previous sternotomy for various reasons; 2.8 Use of thymosin during treatment; 2.9 Presence of autoimmune diseases (such as myasthenia gravis, systemic lupus erythematosus, etc.)

Design outcomes

Primary

MeasureTime frame
Absolute lymphocyte count;

Secondary

MeasureTime frame
The absolute count of T lymphocytes;naive CD4 and CD8 T cells;CD4+, CD8+ activated effector memory cells and central memory cells;

Countries

China

Contacts

Public ContactCai Shang

The Second Affiliated Hospital of Soochow University

cbibbys@163.com+86 67784829

Outcome results

None listed

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