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

May 3, 2025 updated by: Yi-Sheng Chou, Taipei City Hospital

The Efficacy of Sodium Alginate on Prevention of Oral Mucositis and Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

While the use of alginate for preventing radiation-induced esophagitis is under-explored, two existing studies suggest promising outcomes. The first study, conducted in Japan in 1990. However, a second study involving 39 patients demonstrated that administering alginate (10-15cc) four times daily during radiation therapy reduced the severity of oral inflammation. 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.

  1. Study Design: 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.

  2. Inclusion and Exclusion Criteria I.Inclusion Criteria: Patients over 18 years of age. Diagnosed with breast cancer with metastatic lymphadenopathy undergoing adjuvant radiotherapy.Willing to participate in the alginate treatment trial.

    II.Exclusion Criteria: Concurrent chemotherapy during radiation therapy. Cognitive impairment or inability to respond to questionnaire content.Requirement for a low-sodium diet.Conditions such as heart failure, renal insufficiency

  3. Recruitment and Consent Process:

    Eligible patients will be invited to participate during their routine clinic visits. The principal investigator will explain the study protocol in detail, ensuring the patients fully understand the trial. Upon providing signed informed consent, the patients will be enrolled in the study.

  4. Clinical Endpoints:

    I.Primary Endpoint: Evaluation of changes in the quality of life using the EORTC BR23 and QLQ-C30 questionnaires.

    II.Secondary Endpoint: The assessment of radiation therapy side effects, including oral inflammation, sore throat, hoarseness, difficulty swallowing, and a decrease in blood cell counts, as measured by the Common Terminology Criteria for Adverse Events (CTCAE) scale.

    III.Tertiary Endpoints: Evaluation of miRNA and cytokine profile in patient's serum

  5. Expected Outcomes 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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10629
        • Taipei City Hospital, Renai Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years of age.
  • Diagnosed with female breast cancer with metastatic lymphadenopathy undergoing adjuvant radiotherapy.
  • Willing to participate in the alginate treatment trial.

Exclusion Criteria:

  • Concurrent chemotherapy during radiation therapy.
  • Cognitive impairment or inability to respond to questionnaire content.
  • Requirement for a low-sodium diet.
  • Conditions such as heart failure, renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esophagitis prevention
Patients are taking orally alginos suspension 10cc qid on Monday to Friday during the course of radiotherapy
Drug: Alginos Oral Suspension
containing: Sodium alginate 50mg/mL Sodium bicarbonate 26.7mg/mL Calcium carbonate 16mg/mL
Other Names:
  • alginate
  • sodium alginate
No Intervention: Control
Patients are not taking any medications during the course of radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Quality of Life Using a Validated Questionnaire
Time Frame: "From enrollment to the end of treatment at 7 weeks
The validated questionnaire incorporates the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its associated quality of life (QoL) module designed to assess QoL during adjuvant radiotherapy. "QLQ" refers to the Quality of Life Questionnaire. The breast cancer-specific module, QLQ-BR23, is used in conjunction with the core QLQ-C30 instrument. Together, the QLQ-C30 and QLQ-BR23 comprise a total of 53 questions. The instruments include five multi-item scales designed to evaluate body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. These items are rated on a 4-point Likert scale (1 = "not at all" to 4 = "very much"). Additionally, single items assess sexual enjoyment, future perspective, and distress caused by hair loss. Higher scores on these symptom scales indicate greater symptom burden. In contrast, questions 29 and 30 assess overall health and overall quality of life, respectively.
"From enrollment to the end of treatment at 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From enrollment to the end of treatment at 7 weeks
Side effects including oral inflammation, sore throat, hoarseness, difficulty swallowing, anemia, leukopenia, neutropenia, thrombocytopenia, mucositis and esophgitis
From enrollment to the end of treatment at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Investigators

  • Principal Investigator: Yi-Sheng Chou, M.D, Taipei City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 3, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIRB-11211009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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