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NCT06958445: SAFE
The Efficacy of Sodium Alginate on Prevention of Oral Mucositis and Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy
Phase 2 trial testing Alginos Oral Suspension in Breast Carcinoma in 90 participants. Enrolling by invitation.
1 December 2026
Quick facts
| Lead sponsor | Taipei City Hospital |
|---|---|
| Phase | Phase 2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 90 |
| Start date | 15 February 2024 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Alginos Oral Suspension — full drug profile →
Conditions studied
- Breast Carcinoma — all drugs for Breast Carcinoma →
Sponsor
Taipei City Hospital
Who can join
18 and older, female only, with Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06958445
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06958445 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taipei City Hospital
- Last refreshed: 3 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06958445.
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