Идёт набор NCT06642441

Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

Без фазы С лечением Vitamin D Chemotherapy Breast Cancer Adverse Reaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Chemotherapy + vitamin D2, Chemotherapy.
Кому может быть актуально: Состояния в реестре: Vitamin D, Chemotherapy, Breast Cancer, Adverse Reaction. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer

Подробное описание

This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.

Вмешательства

Препарат Chemotherapy + vitamin D2
Before the start of treatment and every 3 weeks thereafter, participants will receive a 10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
Препарат Chemotherapy
Participants will receive a standard adjuvant chemotherapy treatment regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Первичные конечные точки

Incidence and proportion of treatment-related adverse events [Срок оценки: 4-6months]

Вторичные конечные точки (3)

Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0) [Срок оценки: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]
Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale) [Срок оценки: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]
Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale) [Срок оценки: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]

Критерии участия

Критерии включения

Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of
Patients with adjuvant chemotherapy or combined targeted therapy.
Life expectancy of at least 6 months.
No other uncontrolled benign diseases at the time of recruitment.
All patients must have complete clinical medical records.
Willingness to voluntarily sign an informed consent form.