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Mometasone Furoate

Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.

mometasone furoate

placebo

Robert C. Miller, MD

Patricia Griffin, MD

James A. Martenson, MD

RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.

PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

OBJECTIVES:

Primary

* Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Secondary

* Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
* Compare the time to onset and duration of severe radiation dermatitis in these patients.
* Assess skin toxicity and quality of life of these patients.
* Assess the adverse event profile of mometasone furoate in these patients.
* Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast \[post-lumpectomy\] vs chest wall \[post-mastectomy\]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs \> 55 Gy). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
* Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.

Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.

After completion of radiotherapy, patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).

To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.

Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.

Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).

To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.

Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).

Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.

Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Mometasone

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.

Placebo

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All (169) eligible patients are included in the baseline analysis. There were 5 cancels in Arm I and 2 in Arm II.

Robert C. Miller, M.D.

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.

Did not experience grade >=3 radiation dermatitis

Experience grade >=3 radiation dermatitis

Incidence of Severe ( Grade >=3) Radiation Dermatitis

STAT: Discomfort/Burning

STAT: Itching

STAT: Pulling

STAT: Discomfort/Tenderness

Skin Toxicity as Measured by the Skin Toxicity Assessment Tool

Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).

This analysis was not completed due to too little incidence of the dermatitis.

Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.

Patients who completed at least 1 assessment were evaluable for this secondary end point.

Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)

Mental well-being

Physical well-being

Emotional well-being

Social well-being

Spiritual well-being

QOL Domains as Measured by LASA

ARTHRALGIA: Severe

BURN: Mild

BURN: Moderate

BURN: Severe

CELLULITES INFECTN: Moderate

COUGH: Severe

DERMATOLOGY: Mild

DERMATOLOGY: Moderate

DERMATOLOGY: Severe

FATIGUE: Moderate

PAIN: Severe

PAIN-BREAST: Moderate

PAIN-CHEST: Moderate

PRURITUS: Mild

PRURITUS: Moderate

PRURITUS: Severe

SKIN ATROPHY: Mild

SKIN ATROPHY: Moderate

SKIN HYPOPIGMENT: Mild

SKIN HYPOPIGMENT: Moderate

SKIN IRRITATION: Moderate

SKIN STRIAE: Mild

SKIN STRIAE: Moderate

Adverse Events Assessed Clinically by NCI CTCAE v3.0

Redness

Dry Peeling

Wet Peeling

Weeping

Rash

Swelling

Fatigue

Decrease in color

Band, Stripes or Lines

Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).

Overall Study

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10 mg Emthexate, PO, once a week during 8 weeks

200 mcg/day, intranasal mometasone furoate, for 8 weeks

After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week)

Emthexate

Prednol

Yesim Tuncok, MD

Chronic rhinosinusitis with nasal polyposis (CRwNP) is an inflammatory disease of the nasal mucosa. It is presented with severe stuffiness, nasal discharge, facial pressure/pain, and sleep disorders. It leads to severe inconvenience to social life and the quality of life. The first step standard medical therapy consists of the topical intranasal or systemic corticosteroids. Surgery should be considered in the case of medical treatment failure. However, the recurrences are common after both surgery and medical therapies in severe disease and usually require revision surgeries or high dose corticosteroid regimens. On the contrary, either the revision surgeries or the high dose corticosteroid therapies are not capable of preventing the recurrences, treatment failures. Besides, revision surgeries usually lead to high complication rates and high dose corticosteroids usually cause severe adverse effects. The use of the short course topical intranasal corticosteroids after the surgery is generally advocated for these patients. However, the recurrence rates are still high. Hence a new and effective maintenance treatment algorithm with no severe adverse effects is required.

The hypothesis of the clinical trial is an estimated symptom recovery and superiority in both efficacy and safety by the use of low-dose methylprednisolone or methotrexate as compared to the standard maintenance therapy in treatment-resistant CRwNP patients. Therefore, the results of the present study are believed to provide data on novel maintenance therapy and suggest an alternative to the topical intranasal corticosteroids or the high-risk revision surgery.

Methotrexate, as an anti-inflammatory drug used in animal experiments, and low dose systemic corticosteroid treatments have recently been suggested for the treatment of the CRwNP. Despite the several case reports of methotrexate being used for the severe and treatment-resistant CRwNP, the literature is a lack of clinical trials. Likewise, low-dose corticosteroid regimens have not been tested well contrary to the high dose corticosteroid therapy in the same course of the disease. Therefore, the main purpose of this study is to compare a low-dose of methylprednisolone or a low dose of methotrexate treatments with the standard intranasal, topical corticosteroid treatment in human volunteers with medical and surgical treatment-resistant CRwNP.

The present study was planned as a randomized, controlled, triple armed, parallel, open-label phase 2 clinical trial which is conducted in the Department of Otorhinolaryngology at Dokuz Eylül University Hospital. Human volunteers with CRwNP who are resistant to the medical and surgical therapies were recruited to the study. After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 13 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight weeks). Each patient were evaluated by endoscopic examination, the nasal air-flow, the smell threshold, and the blood biochemistry both before and after the medications.

Efficacy goals of the study are located at below:

1. Primary efficacy variable: Lund-Kennedy endoscopic grading system (NPS)
2. Secondary efficacy variables: Total visual analog scale (VAS) score; the Turkish version of the Sinonasal Outcome Test-22 (SNOT-22); sum score of the peak nasal inspiratory flow (PNIF) and butanol olfactory threshold test (BuOT) obtained from bilateral nasal cavities; serum total immunoglobulin E (IgE) level; and the presence of peripheral eosinophilia (PE, \> 500/mcl) in blood samples.

Safety goal of the study was evaluated by the examination of the adverse event reports and the number of patients who experienced adverse events.

Statistical analysis: The normality of the continuous variables was evaluated by the Shapiro Wilk test. Comparison of age was performed using one-way analysis of variance (ANOVA). Repeated measurements in three groups were analyzed using repeated measures ANOVA for 3×3 model with a within and a between-subjects factor. The results were assessed with a 95% confidence interval and at the p\<0.05 significance level.

A Randomized, Controlled, Triple Armed, Parallel, Open-label Phase 2 Clinical Trial

Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis

Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis

Occurrence of polyps, edema, discharge, scar and crusting parameters were scored according to the 0-1-2 rating system.

Smell, nasal discharge, nasal obstruction, facial pressure, and headache were scored between 0 (no complaint) and 10 (most annoying)

Change in the 22-item symptom questionnaire scale used to evaluate the presence of symptoms of chronic rhinosinusitis and their effect on quality of life

During inspiration, nasal peak airflows were detected with the nasal mask attached to the Clement-Clark peak flow-meter. Right and left nostrils of each patient were evaluated separately.

The odor thresholds of the patients who smelled the bottle containing 9 different concentrations of butanol between 0.00061 and 4% were determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ	NCT00438659	Breast Cancer Dermatologic Co... Radiation Toxic... Skin Reactions ...	mometasone furo... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ	NCT00438659	Breast Cancer Dermatologic Co... Radiation Toxic... Skin Reactions ...	mometasone furo... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis	NCT04532736	Nasal Polyposis	Emthexate Prednol Mometasone Furo...	18 Years - 75 Years	Dokuz Eylul University
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis	NCT03401229	Nasal Polyposis	Benralizumab 30... Matching placeb...	18 Years - 75 Years	AstraZeneca
Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis	NCT04532736	Nasal Polyposis	Emthexate Prednol Mometasone Furo...	18 Years - 75 Years	Dokuz Eylul University
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis	NCT03401229	Nasal Polyposis	Benralizumab 30... Matching placeb...	18 Years - 75 Years	AstraZeneca

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