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Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

Award Number: R01CA235726
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/10/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study - In the United States in 2017, most of the 135,000 people diagnosed with colorectal cancer received oxaliplatin to treat stage II-IV disease. About 70% of patients develop oxaliplatin-induced peripheral neuropathy (OIPN) that is characterized by upper and lower extremity numbness (N) and tingling (T), which can persist for years. Painful OIPN develops after N and T in 30% of patients. OIPN (N, T, and pain) poses a major health risk because it is associated with impaired function, falls, depression, impaired sleep, poor quality of life, and is a common reason for chemotherapy dose reductions. A critical gap in our scientific knowledge is that no known preventive interventions for OIPN exist. To address this gap, our overall objective is to test whether duloxetine prevents oxaliplatin-induced N, T, and pain, using a sequential Phase II to Phase III design that will be conducted via the National Cancer Institute (NCI) Community Oncology Research Program (NCORP), a large, multisite research network with access to diverse patient populations. Duloxetine will be tested in this study based on evidence of its efficacy for established OIPN from two clinical trials (Yang et al, 2012; Smith et al., 2013), and our pre-clinical data showing that duloxetine prevents painful OIPN in rats. We will first conduct a randomized, 3-arm, double-blind, placebo-controlled, non-comparative, multi-center study (N = 171) to screen two daily doses of duloxetine—30 mg and 60 mg—to prevent OIPN (N, T, and pain). If duloxetine is shown to be clinically active in the Phase II study, we will proceed to a randomized, double-blind, placebo-controlled, multi-center Phase III study to compare what appears to be the most promising duloxetine dose to placebo. To maximize the use of patient resources, the Phase II data from patients who either completed treatment with placebo (n = 54) or the most promising duloxetine dose (n = 54) will be pooled with data obtained from new Phase III trial accruals to the placebo (n = 70) and most promising duloxetine dose arms (n = 70), respectively (N = 248). We will use pre-established stopping rules to determine the optimal dose based on the proportions of patients who do not develop N, T, and pain, and adverse event severity. The two primary hypotheses in the Phase III study are that the most promising duloxetine dose will be more effective than placebo to prevent 1) N, T, & pain during oxaliplatin treatment and 2) chronic neuropathic pain one month after treatment. The temporal patterns of OIPN and functional impairment will be assessed for 18 months after oxaliplatin treatment. This study addresses the NCI Cancer Moonshot goal to minimize cancer treatment-associated debilitating side effects, and the priority recommendation outlined in the Institute of Medicine's Relieving Pain in America report regarding the need for non-opioid treatments for chronic pain. By addressing these priorities, we expect to make a major advancement in the field of symptom prevention, including pain, by identifying a well-tolerated, widely available, non-opioid, preventive intervention for a distressing and debilitating chemotherapy side effect experienced by millions of cancer survivors, for which no good treatment exists.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $95,851 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	7	4/15/2024	NON-COMPETING CONTINUATION	$5,045
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	7	12/13/2023	NON-COMPETING CONTINUATION	$90,806
														Subtotal = $95,851

Issue Date FY: 2023 ( Subtotal = $291,932 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	6	12/22/2022	NON-COMPETING CONTINUATION	$268,101
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	6	3/14/2023	NON-COMPETING CONTINUATION	$23,831
														Subtotal = $291,932

Issue Date FY: 2022 ( Subtotal = $332,337 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	004	5	5/26/2022	NON-COMPETING CONTINUATION	$33,231
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	003	5	12/22/2021	NON-COMPETING CONTINUATION	$299,106
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	002	4	10/13/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$44,478
2022	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	001	3	10/13/2021	NON-COMPETING CONTINUATION	-$42,581
2022	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	000	2	10/13/2021	NON-COMPETING CONTINUATION	-$1,897
														Subtotal = $332,337

Issue Date FY: 2021 ( Subtotal = $429,156 )
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	000	3	12/30/2020	NON-COMPETING CONTINUATION	$407,698
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	003	4	9/9/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$386,575
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	002	3	9/8/2021	NON-COMPETING CONTINUATION	-$386,575
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	001	3	1/26/2021	NON-COMPETING CONTINUATION	$21,458
														Subtotal = $429,156

Issue Date FY: 2020 ( Subtotal = $195,405 )
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	000	2	6/1/2020	NON-COMPETING CONTINUATION	$195,405
														Subtotal = $195,405

Issue Date FY: 2019 ( Subtotal = $406,827 )
2019	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	000	1	1/10/2019	NEW	$406,827
														Subtotal = $406,827

Grand Total All Awards = $1,751,508

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Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

Award Number: R01CA235726

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/10/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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