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Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Primary Purpose

Oral Mucositis, Stomatitis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Amifostine
Amifostine
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-70 years old, male or female
  2. Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis
  3. Postoperative patients should receive radiation treatment in 12 weeks
  4. ECOG <2
  5. Expected lifetime ≥6months
  6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)
  7. Not involved in other clinical trials
  8. Sign ICF

Exclusion Criteria:

  1. ECOG >2
  2. Suffered other cancers in the past 5 years
  3. Received amifostine treatment in the past 4 weeks
  4. Unable to complete treatment or sign ICF because of medical or physical reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Cytofos group A

    Cytofos group B

    Control group

    Arm Description

    Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times

    Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times

    Radiation treatment 1.8-2.0 Gy/day × 30-35 times

    Outcomes

    Primary Outcome Measures

    Incidence and duration of oral mucositis

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2011
    Last Updated
    November 9, 2021
    Sponsor
    Sun Pharmaceutical Industries Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01288625
    Brief Title
    Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
    Official Title
    Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    There were IP availability issues due to which the study could not be started.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Pharmaceutical Industries Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Mucositis, Stomatitis
    Keywords
    Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cytofos group A
    Arm Type
    Experimental
    Arm Description
    Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
    Arm Title
    Cytofos group B
    Arm Type
    Experimental
    Arm Description
    Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Radiation treatment 1.8-2.0 Gy/day × 30-35 times
    Intervention Type
    Drug
    Intervention Name(s)
    Amifostine
    Intervention Description
    500 mg sc, qod, 3 times per week
    Intervention Type
    Radiation
    Intervention Name(s)
    Amifostine
    Intervention Description
    500mg rinsing wash, qod, 3 times per week
    Primary Outcome Measure Information:
    Title
    Incidence and duration of oral mucositis
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-70 years old, male or female Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis Postoperative patients should receive radiation treatment in 12 weeks ECOG <2 Expected lifetime ≥6months No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.) Not involved in other clinical trials Sign ICF Exclusion Criteria: ECOG >2 Suffered other cancers in the past 5 years Received amifostine treatment in the past 4 weeks Unable to complete treatment or sign ICF because of medical or physical reasons
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang ge
    Organizational Affiliation
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

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