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

NCT06958445 | Enrolling By Invitation Phase 2

• 1 other identifier: TCHIRB-11211009
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Keywords

breast cancer; adjuvant radiotherapy; esophagitis; mucositis; alginate

Outcome Measures

Primary Outcomes (1)

• 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.

  "From enrollment to the end of treatment at 7 weeks

Secondary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  From enrollment to the end of treatment at 7 weeks

Study Arms (2)

Esophagitis prevention

EXPERIMENTAL

Patients are taking orally alginos suspension 10cc qid on Monday to Friday during the course of radiotherapy

Drug: Alginos Oral Suspension

Control

NO INTERVENTION

Patients are not taking any medications during the course of radiotherapy

Interventions

Alginos Oral Suspension DRUG

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

Also known as: alginate, sodium alginate

Esophagitis prevention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who have breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital, Renai Branch

Taipei, 10629, Taiwan

Location

Related Publications (7)

• West K, Schneider M, Wright C, Beldham-Collins R, Coburn N, Tiver K, Gebski V, Stuart KE. Radiation-induced oesophagitis in breast cancer: Factors influencing onset and severity for patients receiving supraclavicular nodal irradiation. J Med Imaging Radiat Oncol. 2020 Feb;64(1):113-119. doi: 10.1111/1754-9485.12943. Epub 2019 Sep 4.

  PMID: 31486274 BACKGROUND

• Upadhyay R, Bazan JG. Advances in Radiotherapy for Breast Cancer. Surg Oncol Clin N Am. 2023 Jul;32(3):515-536. doi: 10.1016/j.soc.2023.03.002.

  PMID: 37182990 BACKGROUND

• Weber WP, Hanson SE, Wong DE, Heidinger M, Montagna G, Cafferty FH, Kirby AM, Coles CE. Personalizing Locoregional Therapy in Patients With Breast Cancer in 2024: Tailoring Axillary Surgery, Escalating Lymphatic Surgery, and Implementing Evidence-Based Hypofractionated Radiotherapy. Am Soc Clin Oncol Educ Book. 2024 Jun;44(3):e438776. doi: 10.1200/EDBK_438776.

  PMID: 38815195 BACKGROUND

• Yu H, Lam KO, Green MD, Wu H, Yang L, Wang W, Jin J, Hu C, Wang Y, Jolly S, Spring Kong FM. Significance of radiation esophagitis: Conditional survival assessment in patients with non-small cell lung cancer. J Natl Cancer Cent. 2021 Feb 18;1(2):31-38. doi: 10.1016/j.jncc.2021.02.003. eCollection 2021 Jun.

  PMID: 39035770 BACKGROUND

• Saldi S, Perrucci E, Fulcheri CPL, Mariucci C, Chierchini S, Ingrosso G, Falcinelli L, Podlesko AM, Merluzzi M, Bini V, Aristei C. Zinc-L-carnosine prevented dysphagia in breast cancer patients undergoing adjuvant radiotherapy: Results of a phase III randomized trial. Breast J. 2020 Sep;26(9):1882-1884. doi: 10.1111/tbj.13855. Epub 2020 May 7. No abstract available.

  PMID: 32383225 BACKGROUND

• Fiets WE, van Helvoirt RP, Nortier JW, van der Tweel I, Struikmans H. Acute toxicity of concurrent adjuvant radiotherapy and chemotherapy (CMF or AC) in breast cancer patients. a prospective, comparative, non-randomised study. Eur J Cancer. 2003 May;39(8):1081-8. doi: 10.1016/s0959-8049(03)00178-3.

  PMID: 12736107 BACKGROUND

• Gay HA, Oh JH, Apte AP, Daly MD, Adkins DR, Rich J, Oppelt PJ, Dyk PT, Mullen DF, Eschen L, Chin RI, Nussenbaum B, Haughey BH, Thorstad WL, Deasy JO. Predictors of acute throat or esophageal patient reported pain during radiation therapy for head and neck cancer. Clin Transl Radiat Oncol. 2018 Sep 4;13:1-6. doi: 10.1016/j.ctro.2018.08.004. eCollection 2018 Nov.

  PMID: 30211324 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Esophagitis; Mucositis

Interventions

Alginates

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Yi-Sheng Chou, M.D

  Taipei City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 6, 2025
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)