Oral MucositisPhase 4NCT01288625
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
A Phase 4 study testing Amifostine in people with Oral Mucositis and Stomatitis, run by Sun Pharmaceutical Industries Limited.
Trial summary
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Mucositis, Stomatitis
- What is being tested?
- Amifostine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.
- Conditions
- Oral Mucositis, Stomatitis
- Being tested
- Amifostine
- Keywords
- Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
500 mg sc, qod, 3 times per week
AmifostineRadiation
500mg rinsing wash, qod, 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Cytofos group A | Experimental | 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 Receives: Drug: Amifostine; Radiation: Amifostine |
| Cytofos group B | Experimental | 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 Receives: Drug: Amifostine; Radiation: Amifostine |
| Control group | Active comparator | Radiation treatment 1.8-2.0 Gy/day × 30-35 times Receives: Drug: Amifostine; Radiation: Amifostine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and duration of oral mucositis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
Why it stopped: There were IP availability issues due to which the study could not be started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang ge, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288625
- Sponsor's protocol ID
- SUN-2011-DP
- Status last verified
- Nov 2021
- First submitted
- 1 Feb 2011
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
- ClinicalTrials.gov ID
- NCT01288625
- Acronym / sponsor ID
- SUN-2011-DP
- Conditions
- Oral Mucositis, Stomatitis
- Keywords
- Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There were IP availability issues due to which the study could not be started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cytofos group A | Experimental | Drug: Amifostine, Radiation: AmifostineAmifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times |
| Cytofos group B | Experimental | Drug: Amifostine, Radiation: AmifostineAmifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times |
| Control group | Active comparator | Drug: Amifostine, Radiation: AmifostineRadiation treatment 1.8-2.0 Gy/day × 30-35 times |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amifostine500 mg sc, qod, 3 times per week | Drug | Control group, Cytofos group A, Cytofos group B |
| Amifostine500mg rinsing wash, qod, 3 times per week | Radiation | Control group, Cytofos group A, Cytofos group B |
Primary outcome
Incidence and duration of oral mucositis
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang ge principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amifostine in people with Oral Mucositis and Stomatitis, run by Sun Pharmaceutical Industries Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and duration of oral mucositis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.