Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study

Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study - UPBEAT-PRO

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058867

Enrollment

100

Registered

2025-09-11

Start date

2025-09-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Female patients aged 40 years or older who have undergone breast-conserving surgery for early breast cancer and are scheduled to receive whole-breast irradiation 2.Female, 40 years of age or older 3.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4.Written informed consent obtained from the patient

Exclusion criteria

Exclusion criteria: 1.Patients requiring supraclavicular lymph node irradiation or boost irradiation 2.Patients scheduled to receive conventional fractionated radiotherapy (e.g., 50 Gy in 25 fractions) 3.History of prior radiotherapy to the same site 4.Presence of evident psychiatric disorders or cognitive impairment that may compromise the reliability of responses to questionnaires 5.Presence of comorbidities judged to have a significant impact on study endpoints 6.Determined by the attending physician to be unsuitable or unable to participate in the study

Design outcomes

Primary

Measure	Time frame
Proportion of patients with PRO-CTCAE-assessed radiation-related skin reactions of moderate or higher severity at any time from treatment initiation to the 7-week post-treatment assessment	—

Secondary

Measure	Time frame
(1)Proportion of patients reporting moderate or higher severity on the PRO-CTCAE for each of the following symptoms at any assessment from treatment initiation to the 7-week post-treatment evaluation: erythema, hyperpigmentation, pruritus, breast swelling/tenderness, skin dryness, pain, and fatigue. (2)Longitudinal changes in PRO-CTCAE scores for the above symptoms. (3)Proportion of patients with CTCAE-graded adverse events occurring at any time from treatment initiation to the 7-week post-treatment evaluation. (4)Distribution of severity grades for each symptom as reported by both PRO-CTCAE and CTCAE. (5)Proportion of patients who selected ultra-hypofractionated radiotherapy (UHF).	—

Measure

Time frame

(1)Proportion of patients reporting moderate or higher severity on the PRO-CTCAE for each of the following symptoms at any assessment from treatment initiation to the 7-week post-treatment evaluation: erythema, hyperpigmentation, pruritus, breast swelling/tenderness, skin dryness, pain, and fatigue. (2)Longitudinal changes in PRO-CTCAE scores for the above symptoms. (3)Proportion of patients with CTCAE-graded adverse events occurring at any time from treatment initiation to the 7-week post-treatment evaluation. (4)Distribution of severity grades for each symptom as reported by both PRO-CTCAE and CTCAE. (5)Proportion of patients who selected ultra-hypofractionated radiotherapy (UHF).

—

Countries

Japan

Contacts

Public ContactTakamasa Mitsuyoshi

Kobe City Medical Center General Hospital Department of Radiation Oncology

mitsu.t@kuhp.kyoto-u.ac.jp078-302-4321

Outcome results