Head and Neck CancerPhase 3NCT00293462
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
A Phase 3 study testing sargramostim and oral salt and soda mouthwash in people with Head and Neck Cancer and Mucositis Oral, run by Marilyn Dodd at 1 site in United States.
Trial summary
GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Mucositis Oral, Radiation Toxicity
- What is being tested?
- sargramostim and oral salt and soda mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2005to 31 Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed diagnosis of head and neck cancer
- Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy
- Planning to receive a total radiation dose ≥ 5,500 centigray (cGy), administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy
- Normal baseline oral examinations (no pre-existing lesion)
- Karnofsky performance status 60-100%
- Mentally capable of participating in research protocol
Show all 13Show fewer
- Expected survival > 4.5 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- Aspartate aminotransferase (AST) < 5 times upper limit of normal
- HIV negative
Who cannot join
- No unresolved adverse event from previous therapy
- No prior radiotherapy to the head and neck
- No prior or concurrent brachytherapy
- No prior participation in this study
- No T1 or T2 glottic tumors
- No other serious concurrent medical illness
Show all 24Show fewer
- No history of insulin-dependent diabetes mellitus
- No prior hypersensitivity reaction to yeast material
- No recent history of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis, or xerostomia
- No current New York Heart Association class II-IV congestive heart failure
- Not pregnant or nursing
- No chemotherapy, radiotherapy, or other investigational drugs within the past 4 weeks
- No major surgery within the past 2 weeks
- No systemic sargramostim (GM-CSF) within the past 7 days
- No systemic filgrastim (G-CSF) within the past 24 hours
- No systemic long-acting pegfilgrastim within the past 14 days
- No antibiotics, antifungals, or antivirals for oral conditions at baseline
- No other concurrent chemotherapy agent
- No concurrent enrollment on other head and neck studies
- No other concurrent investigational drugs
- No concurrent administration of any of the following:
- "Magic or miracle mouthwash" containing a palliative mixture of topical anesthetics/analgesics, coating agents, and other medications without an approved indication for topical oral use except liquid antacid formulations (e.g., Maalox® or Mylanta® or their generic equivalents)
- Other concurrent over-the-counter or prescription mouthwashes beyond the systematic oral care protocol provided by the study or any other drugs or agents to aid in oral hygiene (e.g., chlorhexidine, gluconate, pilocarpine, amifostine, sucralfate tablets or slurry, or benzydamine)
- Use of corticosteroids for chronic conditions OR within the past 7 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol
GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the incidence of radiotherapy (RT)-induced oral mucositis of any grade, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria (RTOG ARMSC)-Mucous Membrane, in patients treated with 1 of 2 mouthwashes (sargramostim [GM-CSF] or salt and soda). (prevention portion of the study)
- Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups (salt and soda, continuing GM-CSF, or new GM-CSF). (treatment portion of the study)
Secondary
- Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices:
- Cumulative RT dose prior to onset of oral mucositis (prevention portion only)
- Severity of RT-induced oral mucositis at onset and during treatment (using Oral Mucositis Assessment Scale (OMAS))
- Severity of oral mucositis-related pain at onset and during treatment (using OMAS)
- Incidence of oral mucositis-related infection at onset and during treatment (using OMAS)
- Severity of oral mucositis-related problems with ingestion of food and fluids at onset and during treatment (using OMAS)
- Time to healing of RT-induced oral mucositis.
- Evaluate patients using the following indirect indices of oral mucositis morbidity during the prevention and treatment portions of the study.
- Tolerance to RT regimen
- Functional status
- Quality of life.
OUTLINE: This is a multicenter, randomized, controlled, double-blinded study. Patients are stratified according to radiotherapy dose schedule (standard vs hyperfractionation vs intensity modulation) and concurrent chemotherapy (yes vs no).
- Prevention (no mucositis): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily.
- Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
Treatment in both arms continues during 6-7 weeks of radiotherapy and/or the onset of mucositis. Patients also perform PRO-SELF: Mouth Aware (PSMA) twice daily.
- Treatment (onset of mucositis): Patients who are currently using GM-CSF mouthwash continue use as in prevention. Patients who are currently using salt and soda mouthwash are randomized to 1 of 2 treatment arms.
- Arm III: Patients receive GM-CSF mouthwash as in arm I.
- Arm IV: Patients receive salt and soda mouthwash as in arm II. In both arms, treatment continues until the mucositis heals. Patients perform PSMA four times daily during and for 3 months after radiotherapy.
Quality of life is assessed at baseline and periodically after radiotherapy.
After completion of study treatment, patients are followed every once a month for 3 months.
- Being tested
- sargramostim, oral salt and soda mouthwash
- Keywords
- Recurrent squamous, basal cell carcinoma of the pharynx,larynx,lip, Oropharynx, paranasal sinus and nasal cavity, Stage I-IV lymphoepithelioma of the nasopharynx, Stage I-IV lymphoepithelioma of the oropharynx, Recurrent esthesioneuroblastoma of paranasal sinus, nasal cavity, Recurrent inverted papilloma of the paranasal sinus, nasal cavity, Recurrent midline granuloma of the paranasal sinus, nasal cavity, Untreated, current, metastatic squamous neck cancer, Recurrent verrucous carcinoma of the larynx, Recurrent lymphoepithelioma of the oropharynx, Stage I verrucous carcinoma of the larynx, Recurrent verrucous carcinoma of the oral cavity, Stage I verrucous carcinoma of the oral cavity, Stage II verrucous carcinoma of the larynx, Stage II verrucous carcinoma of the oral cavity, Stage III verrucous carcinoma of the larynx, Stage III verrucous carcinoma of the oral cavity, Stage IV verrucous carcinoma of the larynx, Stage IV verrucous carcinoma of the oral cavity, Recurrent adenoid cystic carcinoma of the oral cavity
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis, Radiation Injuries, Tongue Neoplasms, Esthesioneuroblastoma, Olfactory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimBiological
oral salt and soda mouthwashOther
Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: GM-CSF Group (GG) | Active comparator | Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Receives: Biological: sargramostim |
| Arm II: Salt & Soda Group (SS) | Active comparator | Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Receives: Other: oral salt and soda mouthwash |
| Arm III: Salt & Soda Switched to GM-CSF (SG) | Active comparator | Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Receives: Biological: sargramostim; Other: oral salt and soda mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported.
Measured: From baseline to onset of mucositis, approximately 16 days
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.
Measured: From onset of mucositis to healing of mucositis, approximately 80 days
Secondary outcomes (3)
Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group
Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. The items on the quality of life questionnaire developed for the study range in scores from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean score for overall quality of life during the study.
Measured: Up to 3 months
Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group
Functional status of participants was measured by administering the KPS which contains items asking about performing daily activities. The scores are grouped in 10s ranging from 100 (Normal, no complaints) to 0 (Dead), with higher scores indicating better functional status. The KPS was administered at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean to determine overall performance status during the course of the study.
Measured: Up to 3 months
Comparison of Combined Mean Score on the Pain Questionnaire by Group
Severity and quality of pain was measured using a pain questionnaire developed for this study with total scores ranging from 0 (no pain) to 10 (most intense pain) with higher scores indicating a greater level of pain. The questionnaire was administered at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were combined to compute one mean to determine overall pain intensity score during the course of the study
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study start7 Jun 2005
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marilyn Dodd
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Marilyn Dodd, University of California, San Francisco
- Investigators
- Marylin J. Dodd, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293462
- Sponsor's protocol ID
- CDR0000459510
- Other IDs
- UCSF-H452-26184-03, 02802, 5R01CA107080
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2006
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol
- ClinicalTrials.gov ID
- NCT00293462
- Acronym / sponsor ID
- CDR0000459510
- Keywords
- Recurrent squamous, basal cell carcinoma of the pharynx,larynx,lip, Oropharynx, paranasal sinus and nasal cavity, Stage I-IV lymphoepithelioma of the nasopharynx, Stage I-IV lymphoepithelioma of the oropharynx, Recurrent esthesioneuroblastoma of paranasal sinus, nasal cavity, Recurrent inverted papilloma of the paranasal sinus, nasal cavity, Recurrent midline granuloma of the paranasal sinus, nasal cavity, Untreated, current, metastatic squamous neck cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Marilyn DoddUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jun 2005 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the incidence of radiotherapy (RT)-induced oral mucositis of any grade, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria (RTOG ARMSC)-Mucous Membrane, in patients treated with 1 of 2 mouthwashes (sargramostim [GM-CSF] or salt and soda). (prevention portion of the study)
- Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups (salt and soda, continuing GM-CSF, or new GM-CSF). (treatment portion of the study)
Secondary
- Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices:
- Cumulative RT dose prior to onset of oral mucositis (prevention portion only)
- Severity of RT-induced oral mucositis at onset and during treatment (using Oral Mucositis Assessment Scale (OMAS))
- Severity of oral mucositis-related pain at onset and during treatment (using OMAS)
- Incidence of oral mucositis-related infection at onset and during treatment (using OMAS)
- Severity of oral mucositis-related problems with ingestion of food and fluids at onset and during treatment (using OMAS)
- Time to healing of RT-induced oral mucositis.
- Evaluate patients using the following indirect indices of oral mucositis morbidity during the prevention and treatment portions of the study.
- Tolerance to RT regimen
- Functional status
- Quality of life.
OUTLINE: This is a multicenter, randomized, controlled, double-blinded study. Patients are stratified according to radiotherapy dose schedule (standard vs hyperfractionation vs intensity modulation) and concurrent chemotherapy (yes vs no).
- Prevention (no mucositis): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily.
- Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
Treatment in both arms continues during 6-7 weeks of radiotherapy and/or the onset of mucositis. Patients also perform PRO-SELF: Mouth Aware (PSMA) twice daily.
- Treatment (onset of mucositis): Patients who are currently using GM-CSF mouthwash continue use as in prevention. Patients who are currently using salt and soda mouthwash are randomized to 1 of 2 treatment arms.
- Arm III: Patients receive GM-CSF mouthwash as in arm I.
- Arm IV: Patients receive salt and soda mouthwash as in arm II. In both arms, treatment continues until the mucositis heals. Patients perform PSMA four times daily during and for 3 months after radiotherapy.
Quality of life is assessed at baseline and periodically after radiotherapy.
After completion of study treatment, patients are followed every once a month for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I: GM-CSF Group (GG) | Active comparator | Biological: sargramostimArm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. |
| Arm II: Salt & Soda Group (SS) | Active comparator | Other: oral salt and soda mouthwashArm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. |
| Arm III: Salt & Soda Switched to GM-CSF (SG) | Active comparator | Biological: sargramostim, Other: oral salt and soda mouthwashArm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histopathologically confirmed diagnosis of head and neck cancer
- Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy
- Planning to receive a total radiation dose ≥ 5,500 centigray (cGy), administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy
- Normal baseline oral examinations (no pre-existing lesion)
- Karnofsky performance status 60-100%
Key exclusion criteria (24 listed)
- No unresolved adverse event from previous therapy
- No prior radiotherapy to the head and neck
- No prior or concurrent brachytherapy
- No prior participation in this study
- No T1 or T2 glottic tumors
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 |
|---|---|---|
| sargramostim | Biological | Arm I: GM-CSF Group (GG), Arm III: Salt & Soda Switched to GM-CSF (SG) |
| oral salt and soda mouthwashPatients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. | Other | Arm II: Salt & Soda Group (SS), Arm III: Salt & Soda Switched to GM-CSF (SG) |
Primary outcome
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
Time frame: From baseline to onset of mucositis, approximately 16 days
The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported.
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
Time frame: From onset of mucositis to healing of mucositis, approximately 80 days
The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.
3 secondary outcomes
Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group
Time frame: Up to 3 months
Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group
Time frame: Up to 3 months
Comparison of Combined Mean Score on the Pain Questionnaire by Group
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Marylin J. Dodd, RN, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sargramostim and oral salt and soda mouthwash in people with Head and Neck Cancer and Mucositis Oral, run by Marilyn Dodd at 1 site in United States.
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 13 inclusion and 24 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: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) (time frame: From baseline to onset of mucositis, approximately 16 days). The study lists 2 primary outcomes in all. 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 30 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.