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Melanotan-I

Afamelanotide, MT-I, [Nle4-D-Phe7]-α-MSH, Scenesse, CUV-1647

Quick Stats
Studies 225
Trials 100
Terminated PHASE3 INTERVENTIONAL NCT03839940

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.

Detailed Description

PRIMARY OBJECTIVES: I. To determine if the initiation of dexamethasone at the start of everolimus treatment prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the initiation of placebo. II. To determine if the initiation of dexamethasone at the start of everolimus treatment will be superior compared to the initiation of placebo in terms of the overall severity of mIAS-associated pain. SECONDARY OBJECTIVES: I. To utilize the same measurement method that was reported in the SWISH trial: A combination of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician grading of stomatitis to determine the incidence of \> grade 2 mIAS. II. To determine if the initiation of dexamethasone at the start of everolimus increases time to development of mouth pain using daily numerical analog scale patient-reported data collection. III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the same time as everolimus use versus at the time when mouth pain begins. IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus improves patients' ability to adhere to everolimus therapy. V. To compare dexamethasone prescription fill rates and timing between patients who received placebo versus study drug at the initiation of everolimus. Trial Design: OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks. GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over 2 minutes QID for 8 weeks.

Interventions

Name: Dexamethasone
Type: DRUG
Description: Given as mouthwash
Name: Placebo
Type: OTHER
Description: Given as mouthwash
Name: Questionnaire
Type: OTHER
Description: Ancillary studies
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies
Name: Everolimus
Type: DRUG
Description: Standard of care

Primary Outcomes

Measure: Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale
TimeFrame: Up to 8 weeks
Description: The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
Measure: Severity of Mouth Pain Scores
TimeFrame: Up to 8 weeks
Description: Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.

Trial Information

NCT ID

NCT03839940

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Last Updated

December 15, 2025

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