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Exercise as Interception Therapy in Primary High Risk Cancer

Award Number: R01CA244866
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/03/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Exercise as Interception Therapy in Primary High Risk Cancer - ABSTRACT Advances in screening and adjuvant therapy have significantly improved disease outcomes in primary (early-stage) cancer, however 30% still experience relapse despite curative treatment. Recurrent (metastatic) disease is currently incurable. Thus, effective strategies to prevent disease recurrence in those patients at highest risk are of major clinical importance. Exercise therapy is a well-tolerated strategy that may also hold significant promise to control MRD in breast, prostate, and colorectal cancer. Observational studies show that self-reported exercise is associated with 20% to 60% reductions in the risk of relapse in primary breast, prostate, and colorectal cancer. Moreover, these observations extend to patients with high-risk (e.g., stage 3, node positive) disease. In preclinical support of these data, we have demonstrated exercise significantly inhibits primary tumor growth in aggressive mouse models of breast, colorectal, and prostate cancer. Finally, we have translated the development of exercise interventions to the clinic with numerous prospective trials demonstrating exercise training is safe, well- tolerated, and exhibits significant pharmacodynamic (PD) activity as illustrated by favorable alterations in the circulating availability of multiple growth factors and hormones as well as inflammatory-immune effectors known to affect cancer cell proliferation and survival in breast, prostate, and colorectal cancer. Collectively, the encouraging data strongly support further clinical investigation of whether exercise has adjuvant therapy benefit in patients with primary solid tumors. We will conduct a phase 1a/1b study of exercise in primary cancer patients at high-risk of disease relapse. We will leverage analysis of circulating tumor DNA (ctDNA) to: (1) identify those at high-risk of relapse, and (2) monitor therapeutic response to exercise. This grant has two specific aims: (1) Aim 1: Phase 1a Dose- Finding and (2) Aim 2: Phase 1b Dose Expansion.


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: 2026 ( Subtotal = $0 )
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	5	11/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $693,662 )
2025	2025	BECKMAN RESEARCH INSTITUTE OF THE CITY OF HOPE	1500 DUARTE RD	DUARTE	CA	91010	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	6	8/28/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$693,662
2025	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	5	8/27/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $693,662

Issue Date FY: 2024 ( Subtotal = $624,661 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	5	5/27/2024	NON-COMPETING CONTINUATION	$624,661
														Subtotal = $624,661

Issue Date FY: 2023 ( Subtotal = $644,390 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	4	7/25/2023	NON-COMPETING CONTINUATION	$644,390
														Subtotal = $644,390

Issue Date FY: 2022 ( Subtotal = $644,389 )
2022	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	6/23/2022	NON-COMPETING CONTINUATION	$644,389
														Subtotal = $644,389

Issue Date FY: 2021 ( Subtotal = $193,799 )
2021	2021	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	2	6/28/2021	NON-COMPETING CONTINUATION	$193,799
														Subtotal = $193,799

Issue Date FY: 2020 ( Subtotal = $725,188 )
2020	2020	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	9/3/2020	NEW	$725,188
														Subtotal = $725,188

Grand Total All Awards = $3,526,089

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Exercise as Interception Therapy in Primary High Risk Cancer

Award Number: R01CA244866

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/03/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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