A Phase 2 interventional study of Alginos Oral Suspension in Breast Carcinoma, sponsored by Taipei City Hospital. Enrolling by invitation at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Taipei City Hospital · Phase 2, Interventional, and Supportive care
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.
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.
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
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.
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 90 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Taipei City Hospital is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are taking orally alginos suspension 10cc qid on Monday to Friday during the course of radiotherapy
Drug: Alginos Oral Suspension
Patients are not taking any medications during the course of radiotherapy
Drug pages: Alginates · Alginic Acid
containing: Sodium alginate 50mg/mL Sodium bicarbonate 26.7mg/mL Calcium carbonate 16mg/mL
Also known as: alginate, sodium alginate
Assessment of Quality of Life Using a Validated Questionnaire
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.
Time frame: "From enrollment to the end of treatment at 7 weeks
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Side effects including oral inflammation, sore throat, hoarseness, difficulty swallowing, anemia, leukopenia, neutropenia, thrombocytopenia, mucositis and esophgitis
Time frame: From enrollment to the end of treatment at 7 weeks
Plan to share: No
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Studies of the drugs tested here: Alginates · Alginic Acid
Taipei City Hospital