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Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Mucositis, Radiation Toxicity

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Trial Information

Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol


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.

PROJECTED ACCRUAL: A total of 222 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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 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)

- No T1 or T2 glottic tumors

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Mentally capable of participating in research protocol

- Expected survival > 4.5 months

- No other serious concurrent medical illness

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Bilirubin ≤ 2.0 mg/dL

- AST < 5 times upper limit of normal

- HIV negative

- 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

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- 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 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis

Outcome Description:

Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.

Outcome Time Frame:

Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)

Safety Issue:

No

Principal Investigator

Marylin J. Dodd, RN, PhD, FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000459510

NCT ID:

NCT00293462

Start Date:

May 2005

Completion Date:

December 2009

Related Keywords:

  • Head and Neck Cancer
  • Mucositis
  • Radiation Toxicity
  • mucositis
  • radiation toxicity
  • recurrent squamous and basal cell carcinoma of the hypopharynx,larynx,lip,nasopharynx
  • oropharynx, paranasal sinus and nasal cavity
  • stage I-IV lymphoepithelioma of the nasopharynx
  • stage I-IV lymphoepithelioma of the oropharynx
  • Recurrent and stage I-IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • Recurrent and stage I-IV inverted papilloma of the paranasal sinus and nasal cavity
  • Recurrent and stage I-IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • untreated, current,metastatic squamous neck cancer with occult primary
  • 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
  • stage I adenoid cystic carcinoma of the oral cavity
  • stage II adenoid cystic carcinoma of the oral cavity
  • stage III adenoid cystic carcinoma of the oral cavity
  • stage IV adenoid cystic carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • stage I mucoepidermoid carcinoma of the oral cavity
  • stage II mucoepidermoid carcinoma of the oral cavity
  • stage III mucoepidermoid carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • tongue cancer
  • Head and Neck Neoplasms
  • Radiation Injuries
  • Mucositis

Name

Location
University of California, San Francisco School of Nursing San Francisco, California  94115