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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:February 15, 2019
End Date:September 2022
Contact:Kathryn Ruddy, MD
Email:ruddy.kathryn@mayo.edu
Phone:507-293-1732

Use our guide to learn which trials are right for you!

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches

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.

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.

Inclusion Criteria:

- Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without
an endocrine agent. Patients about to receive everolimus for off label use for any
cancer are also eligible.

- Not currently receiving chemotherapy or any other agent known to cause mucositis or
stomatitis. Trastuzumab and ovarian function suppression are allowed.

- Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed
at least 2 weeks prior to registration.

- Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not
have had any stomatitis or mouth pain for at least 7 days prior to registration.

- Patients should not receive any other agent which would be considered treatment for
stomatitis or impact the primary endpoint.

- No history of candida infection (thrush) within the last 3 months.

- Not currently being treated with corticosteroids.

- No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although
A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone
with diabetes or suspected diabetes.

- Patients must be able to read and comprehend English. Local translation, including
verbal translation of professionals (PROs) is not permitted.

- Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
are unknown. Therefore, for women of childbearing potential only, a negative pregnancy
test done =< 7 days prior to registration is required.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
We found this trial at
33
sites
7500 Mercy Road
Omaha, Nebraska 68124
Principal Investigator: Ralph J. Hauke
Phone: 402-393-3110
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Anaconda, MT
Click here to add this to my saved trials
3325 Pocahontas Road
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Baker City, OR
Click here to add this to my saved trials
Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Boise, ID
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
3123 Medical Dr
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Caldwell, ID
Click here to add this to my saved trials
Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
?
mi
from
Cody, WY
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Principal Investigator: Robert J. Behrens
Phone: 515-241-8704
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1202 East Locust Street
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Emmett, ID
Click here to add this to my saved trials
802 Kenyon Road
Fort Dodge, Iowa 50501
Principal Investigator: Robert J. Behrens
Phone: 515-574-8302
?
mi
from
Fort Dodge, IA
Click here to add this to my saved trials
1117 29th St S
Great Falls, Montana 59405
(406) 771-7300
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
1400 29th Street South
Great Falls, Montana 59405
406-454-2171
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Helena, Montana 59601
Principal Investigator: Benjamin T. Marchello
Phone: 773-702-9171
?
mi
from
Helena, MT
Click here to add this to my saved trials
310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Lincoln, Nebraska 68506
Principal Investigator: Ralph J. Hauke
Phone: 402-484-4911
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Lincoln, Nebraska 68510
Principal Investigator: Ralph J. Hauke
Phone: 402-327-7363
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Meridian, Idaho 83642
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Missoula, Montana 59801
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Missoula, MT
Click here to add this to my saved trials
1512 12th Avenue Road
Nampa, Idaho 83686
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Nampa, ID
Click here to add this to my saved trials
Norfolk, Nebraska 68701
Principal Investigator: Ralph J. Hauke
Phone: 402-644-7534
?
mi
from
Norfolk, NE
Click here to add this to my saved trials
North Platte, Nebraska 69101
Principal Investigator: Ralph J. Hauke
Phone: 308-696-7864
?
mi
from
North Platte, NE
Click here to add this to my saved trials
Omaha, Nebraska 68124
Principal Investigator: Ralph J. Hauke
Phone: 402-334-4773
?
mi
from
Omaha, NE
Click here to add this to my saved trials
351 Southwest 9th Street
Ontario, Oregon 97914
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
?
mi
from
Ontario, OR
Click here to add this to my saved trials
Post Falls, Idaho 83854
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Post Falls, ID
Click here to add this to my saved trials
Sandpoint, Idaho 83864
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Sandpoint, ID
Click here to add this to my saved trials
3911 Avenue B
Scottsbluff, Nebraska 69361
Principal Investigator: Ralph J. Hauke
Phone: 402-991-0070
?
mi
from
Scottsbluff, NE
Click here to add this to my saved trials
1585 W 5th St
Sheridan, Wyoming 82801
(307) 674-5400
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Welch Cancer Center People in our community don't need to leave home to find high...
?
mi
from
Sheridan, WY
Click here to add this to my saved trials
1660 60th St
West Des Moines, Iowa 50266
(515) 343-1000
Principal Investigator: Robert J. Behrens
Phone: 515-343-1000
Methodist West Hospital Methodist West Hospital has become the "go-to" destination for medical care. Our...
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials