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Molgramostim

Sargramostim

Immunologic Factors

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.

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.

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.

sargramostim

Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.

oral salt and soda mouthwash

Marylin J. Dodd, RN, PhD

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.

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.

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

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

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.

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.

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.

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.

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

National Cancer Institute (NCI)

Marilyn Dodd

Principal Investigator

Serious Adverse Events and adverse events were collected in the safety population which is comprised of all participants who were both randomized and received at least one dose of the study medication. Number of participants at risk represents the number of participants who received study medications.

Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm I: GM-CSF Group (GG)

Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm II: Salt & Soda Group (SS)

Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.

Arm III: Salt & Soda Switched to GM-CSF (SG)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Marylin J. Dodd, RN, PhD, FAAN

Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash

Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)

Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used

Comparison of the Mean Number of Days for Mucositis to Heal Across by Group

Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis.

Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group

Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.

Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group

Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer	NCT00293462	Head and Neck C... Mucositis Oral Radiation Toxic... Tongue Cancer	sargramostim oral salt and s...	18 Years -	University of California, San Francisco
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer	NCT00293462	Head and Neck C... Mucositis Oral Radiation Toxic... Tongue Cancer	sargramostim oral salt and s...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for recurrent inverted papilloma of the paranasal sinus, nasal cavity