Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06642428

Reclutamento in corso

Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

Interventistico

Fase non elencata

Qinghai University Affiliated Hospital

Sponsor: Jiuda Zhao

Ultimo Aggiornamento: 17 gennaio 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

18 ottobre 2024

Ultimo Aggiornamento dello Sponsor

17 gennaio 2025

Completamento Stimato

31 gennaio 2026

Contatto dello studio

Nome:Jiuda Zhao

Email:jiudazhao@126.com

Telefono:869716230893

Idoneità

Criteri di Inclusione

1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.

3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).

4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.

6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.

Criteri di Esclusione

1. History of invasive breast cancer.

2. Prior systemic treatment for the treatment or prevention of breast cancer.

3. Known allergic reactions to vitamin D or calcium compounds.

4. Comorbidities that may affect vitamin D or calcium balance or bone health.

5. Vitamin D or calcium supplementation in the past 3 months.

6. Presence of other tumors.

7. Pregnant or lactating women.

8. Individuals who do not wish to participate in the study.

Pensi che questo studio appaia erroneamente?

Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare140

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Before the start of treatment and every 3 weeks thereafter, participants will receive injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.

Interventi:

Neoadjuvant therapy + vitamin D2
Neoadjuvant therapy

Misure di Esito

Misure di Esito Primarie

The objective response rate4-6months

Difference in change in the objective response rate from first to last assessment between two arms

The pathological complete response rate4-6months

Difference in change the pathological complete response rate from first to last assessment between two arms

Misure di Esito Secondarie

The disease control rate4-6months

Difference in change the disease control rate rate from first to last assessment between two arms

Evaluation of side effects related to neoadjuvant therapy (CTCAE v5.0).From the initiation of neoadjuvant therapy to 21 days after the last cycle of neoadjuvant therapy.

Side effects of neoadjuvant therapy will be assessed according to the CTCAE v5.0 criteria.

Pathological response assessment using the Miller & Payne scoring system in conjunction with residual disease in lymph nodes following neoadjuvant therapy.4-6months

The pathological response will be assessed using the Miller & Payne scoring system, considering residual disease in lymph nodes after neoadjuvant therapy.

Aggiungi studio ai preferiti

Condividi Studio

Scarica lo studio

Pensi che questo studio appaia erroneamente?

Segnala Studio

Scarica lo studio

Siti dello Studio

Questo studio ha 1 sito

Qinghai University Affiliated Hospital

Xining, Qinghai, CN

Nome:Jiuda Zhao, Dr

Email:jiudazhao@126.com

Telefono:869716230893

Non ancora in reclutamento

Xining, Qinghai, 810000 CN

Qinghai University Affiliated Hospital

Loading Maps...