Axillary–lateral thoracic vessel juncture sparing and 2-year breast cancer–related lymphedema after postmastectomy radiotherapy: a prospective nonrandomized concurrently controlled study

ISRCTN	ISRCTN17585393
DOI	https://doi.org/10.1186/ISRCTN17585393
Sponsor	Changshu No.1 People's Hospital
Funder	2023 Changshu Health Commission Science and Technology Plan Sponsored Projects and Changshu Science and Technology Development Plan (Medical and Health) Guidance Projects (CSWS202304)

Submission date: 11/11/2026
Registration date: 12/11/2026
Last edited: 12/11/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Chong Yu
Principal investigator, Scientific, Public

Shuyuanjie 1st
Changshu
215500
China

ORCID ID	0000-0002-8812-3368
Phone	+86 18015621131
Email	kulousheng@163.com

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Dose comparison
Assignment	Parallel
Purpose	Treatment
Scientific title	A randomized non-inferiority clinical study on the effect of axillary organ-at-risk sparing during postmastectomy radiotherapy on breast cancer–related lymphedema
Study objectives
Ethics approval(s)	Approved 21/07/2023, Changshu No.1 People’s Hospital Ethics Committee (Shuyuanjie 1st, Changshu, 215500, China; +86 512 52223969; no email provided), ref: X2023033
Health condition(s) or problem(s) studied	Prevention of breast cancer-related lymphedema in patients undergoing radical mastectomy who receive postoperative radiotherapy
Intervention	Patients were assigned to conventional or ALTJ-sparing planning using a prespecified alternating sequence. Allocation was deterministic and nonrandom. In the conventional group, the ALTJ was delineated for dosimetric analysis but excluded from optimization. In the ALTJ-sparing group, ALTJ V30 ≤50% was added as a planning objective. Planning target volume (PTV) coverage and conventional OAR constraints, particularly for the heart and lungs, took priority, and the ALTJ objective could be relaxed when necessary. Both groups received identical postoperative rehabilitation exercises and BCRL-prevention education. Bilateral arm circumferences were measured 5 and 15 cm above and 10 cm below the olecranon before radiotherapy, immediately after completion (month 0), and every 3 months thereafter. BCRL required a baseline-adjusted increase of ≥2 cm in the affected-minus-contralateral arm circumference difference at any site, confirmed at the next visit.
Intervention type	Behavioural
Primary outcome measure(s)	The cumulative incidence of Bilateral arm circumferences measured using tape measure at 5 and 15 cm above and 10 cm below the olecranon at immediately after completion (month 0), and every 3 months thereafter
Key secondary outcome measure(s)	ALTJ dosimetric parameters, and differences in PTV coverage, CI, HI, and dosimetric parameters for conventional OARs, including the heart and lungs. measured using data extracted from the treatment planning system at after radiotherapy
Completion date	30/09/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	34 Years
Upper age limit	78 Years
Sex	Female
Target sample size at registration	110
Total final enrolment	110
Key inclusion criteria	1. Female sex 2. Age <80 years 3. Karnofsky Performance Status (KPS) >80 4. Histologically confirmed invasive breast cancer treated with modified radical mastectomy 5. An indication for postoperative regional radiotherapy, including a primary tumor >5 cm, ≥4 positive axillary lymph nodes, or T1-2 disease with 1-3 positive axillary lymph nodes accompanied by high-risk features, such as <10 axillary lymph nodes retrieved, lymphovascular invasion, triple-negative breast cancer, or age <35 years 6. No contraindication to radiotherapy 7. No evidence of upper-extremity lymphedema before radiotherapy 8. The ability to understand and comply with the scheduled follow-up and upper-extremity measurements
Key exclusion criteria	1. Had a history of ipsilateral upper-extremity lymphedema or preexisting upper-extremity swelling before radiotherapy 2. Another concurrent malignancy 3. Bilateral breast cancer 4. Were considered unlikely to complete the prescribed treatment or scheduled follow-up
Date of first enrolment	21/07/2023
Date of final enrolment	30/06/2024

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication

Editorial Notes

12/11/2026: Trial's existence confirmed by Changshu No.1 People’s Hospital Ethics Committee.