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Prevention of Oral Mucositis and Improvement of Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy

NCT06958445 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-06

No results posted yet for this study

Summary

Breast cancer patients receiving adjuvant radiotherapy after surgery, particularly when the supraclavicular lymph nodes are included in the treatment area, frequently experience side effects of esophagitis such as sore throat, hoarseness, difficulty swallowing, and a reduction in white blood cell counts. Currently, no specific treatments exist to mitigate these adverse effects. This study proposes the use of alginate as a potential solution to alleviate these symptoms and improve the quality of life in breast cancer patients undergoing radiotherapy.

Although the side effects of radiotherapy do not typically pose a clinical risk, they have a profound impact on patients' quality of life, particularly affecting nutrition intake and well-being. This study aims to evaluate whether alginate can prevent these radiotherapy-induced side effects and improve the overall quality of life for breast cancer patients.

The trial will be conducted with 150 breast cancer patients undergoing adjuvant radiotherapy after surgery. The patients will receive 10cc of alginate orally, four times daily. Weekly evaluations will be conducted to assess the presence and improvement of symptoms such as sore throat, hoarseness, difficulty swallowing, and changes in white blood cell counts. Quality of life will be measured using the EORTC BR23 and QLQ-C30 questionnaires at the first and last sessions of radiation therapy.

The study aims to determine whether alginate can effectively prevent the side effects of radiation therapy, such as oral inflammation, sore throat, hoarseness, difficulty swallowing, and a decrease in blood cell counts. Furthermore, it will evaluate whether these improvements lead to a better quality of life for breast cancer patients undergoing adjuvant radiotherapy.

Conditions

  • Breast Carcinoma

Interventions

DRUG

Alginos Oral Suspension

containing: Sodium alginate 50mg/mL Sodium bicarbonate 26.7mg/mL Calcium carbonate 16mg/mL

Sponsors & Collaborators

  • Taipei City Hospital

    lead OTHER_GOV

Principal Investigators

  • Yi-Sheng Chou, M.D · Taipei City Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958445 on ClinicalTrials.gov