Clinical trial NCT06958445: Prevention of Oral Mucositis and Improvement of Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy
Official title: The Efficacy of Sodium Alginate on Prevention of Oral Mucositis and Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Breast Carcinoma
Keywords: breast cancer
adjuvant radiotherapy
esophagitis
mucositis
alginate
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Quality of Life Using a Validated Questionnaire
timeFrame: "From enrollment to the end of treatment at 7 weeks
Secondary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: From enrollment to the end of treatment at 7 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital, Renai Branch
Study officials:
affiliation: Taipei City Hospital
name: Yi-Sheng Chou, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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