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Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Primary Purpose

Head and Neck Cancer, Oral Mucositis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zi-Yin-Liang-Ge-San
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven stage II-IV squamous HNC
  • Indication for radiotherapy or radio-chemotherapy
  • No history of antitumor therapies
  • No history of oral ulcer and salivary gland diseases
  • Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

  • Terminal cancer for which aggressive treatments were not suitable
  • Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit)
  • Uncontrolled psychiatric problems or altered mental status
  • Had received medications for other clinical trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Chinese herbal medicine treatment

    Non-Chinese herbal medicine treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Degree of oral mucositis
    The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
    Mucositis pain
    100-mm-visual analog scale (VAS, 0-100)

    Secondary Outcome Measures

    Health related-QoL (1)
    EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
    Health related-QoL (2)
    Quality of Life Head and Neck Module (QLQ-H&N35)
    Body mass index (BMI)
    Body mass index (BMI)

    Full Information

    First Posted
    September 3, 2021
    Last Updated
    September 7, 2021
    Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    National Research Institute of Chinese Medicine, Ministry of Health and Welfare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05040425
    Brief Title
    Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
    Official Title
    Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 30, 2021 (Anticipated)
    Primary Completion Date
    August 17, 2022 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    National Research Institute of Chinese Medicine, Ministry of Health and Welfare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
    Detailed Description
    200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Oral Mucositis
    Keywords
    Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants selected at screening who provide written informed consent will be randomly allocated to two groups. One will be submitted to Chinese herbal medicine group, and the other to control group.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chinese herbal medicine treatment
    Arm Type
    Experimental
    Arm Title
    Non-Chinese herbal medicine treatment
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Zi-Yin-Liang-Ge-San
    Intervention Description
    Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP).
    Primary Outcome Measure Information:
    Title
    Degree of oral mucositis
    Description
    The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
    Time Frame
    During the radiotherapy course, up to 6 weeks
    Title
    Mucositis pain
    Description
    100-mm-visual analog scale (VAS, 0-100)
    Time Frame
    During the radiotherapy course, up to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Health related-QoL (1)
    Description
    EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
    Time Frame
    Baseline, 4th week, and 6th week of radiotherapy completion
    Title
    Health related-QoL (2)
    Description
    Quality of Life Head and Neck Module (QLQ-H&N35)
    Time Frame
    Baseline, 4th week, and 6th week of radiotherapy completion
    Title
    Body mass index (BMI)
    Description
    Body mass index (BMI)
    Time Frame
    During the radiotherapy course, up to 6 weeks
    Other Pre-specified Outcome Measures:
    Title
    Traditional Chinese medicine constitution
    Description
    Body Constitution Questionnaire (BCQ)
    Time Frame
    Baseline, 4th week, and 6th week of radiotherapy completion
    Title
    Electrical body conductivity
    Description
    Meridian Energy Analysis Device
    Time Frame
    Baseline, 4th week, and 6th week of radiotherapy completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically proven stage II-IV squamous HNC Indication for radiotherapy or radio-chemotherapy No history of antitumor therapies No history of oral ulcer and salivary gland diseases Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: Terminal cancer for which aggressive treatments were not suitable Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit) Uncontrolled psychiatric problems or altered mental status Had received medications for other clinical trials
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ming-Yen Tsai, PhD
    Phone
    +886975056534
    Email
    missuriae@yahoo.com.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.

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    Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

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