Thursday, July 31, 2025 7/31/2025

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Award Number: U01CA271279
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/03/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2027

Group Awards By:

View Award Description

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer - PROJECT SUMMARY/ABSTRACT Patients with colon cancer who require chemotherapy dose reductions and treatment delays are twice as likely to experience disease recurrence and death than patients who complete their full chemotherapy dose on time. Up to 60% of patients develop toxicities of sufficient severity to require chemotherapy dose reductions or treatment delays. We hypothesize that aerobic exercise improves chemotherapy relative dose intensity and reduces patient-reported chemotherapy toxicities by improving the calibration of chemotherapy through changes in body composition and altering immune function. In response to RFA-CA-21-031, we will conduct a Bayesian, multi-stage, response-adaptive, dose-ranging trial of aerobic exercise. Participants will be 219 stage II-III colon cancer survivors recruited from three diverse socioeconomic, racial, and geographic regions (Baton Rouge, LA; Boston, MA; Oakland, CA). The first 80 participants are randomized to 1 of 5 groups equally: moderate-intensity aerobic exercise at 75 min/wk, 150 min/wk, 225 min/wk, 300 min/wk, or attention control (stretching). This is followed by adaptive randomization in which subsequent participants are assigned to an exercise group in a ratio proportional to the probability that the specific exercise group improves chemotherapy dose intensity and is feasible. Exercise is chemotherapy-periodized with more and less demanding weeks to accommodate cyclical variations in patient-reported symptoms. Aim 1 will evaluate the dose-response effects of moderate-intensity aerobic exercise compared with attention control on chemotherapy relative dose intensity (primary endpoint). Aim 2 will determine the effect of moderate-intensity aerobic exercise compared with control on gastrointestinal and peripheral neuropathy symptoms assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE (key secondary endpoint)]. Aim 3 will determine the effect of moderate-intensity aerobic exercise compared with control on whole-body tissue distribution (total body fat mass and lean mass) measured using dual-energy x-ray absorptiometry. Aim 4 will determine the effect of moderate-intensity aerobic exercise compared with control on changes in neutrophil counts, phenotypes, and functions (biomarkers of neutrophil effector functions including elastase, citrullinated Histone H3, and myeloperoxidase and direct measures of chemotaxis and oxidative burst). This study will leverage a transdisciplinary team's synergies to identify an exercise prescription that is patient-centered and proven to have a high probability of clinical benefit. This study will directly inform clinical practice guidelines that recognize exercise as an essential supportive care intervention for chemotherapy and establish exercise training as obligatory for delivering high-quality, evidence-based care to colon cancer survivors.


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: 2025 ( Subtotal = $0 )
2025	2024	PENNINGTON BIOMEDICAL RESEARCH CENTER	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	001	3	6/10/2025	NON-COMPETING CONTINUATION	-$302,223
2025	2024	ADVENTIST HEALTH SYSTEM/SUNBELT INC	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Cancer Cause and Prevention Research	002	4	6/11/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$302,223
2025	2024	LSU PENNINGTON	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	000	3	10/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,039,248 )
2024	2024	LSU PENNINGTON	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	002	3	5/31/2024	NON-COMPETING CONTINUATION	$1,039,248
2024	2023	LOUISIANA STATE UNIVERSITY SYSTEM	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	001	2	10/19/2023	NON-COMPETING CONTINUATION	$0
2024	2022	LOUISIANA STATE UNIVERSITY SYSTEM	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	000	1	10/19/2023	NEW	$0
														Subtotal = $1,039,248

Issue Date FY: 2023 ( Subtotal = $1,075,931 )
2023	2023	LOUISIANA STATE UNIVERSITY SYSTEM	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	000	2	5/19/2023	NON-COMPETING CONTINUATION	$1,075,931
														Subtotal = $1,075,931

Issue Date FY: 2022 ( Subtotal = $1,184,061 )
2022	2022	LOUISIANA STATE UNIVERSITY SYSTEM	6400 PERKINS RD	BATON ROUGE	LA	70808	EAST BATON ROUGE	USA	Cancer Cause and Prevention Research	000	1	5/30/2022	NEW	$1,184,061
														Subtotal = $1,184,061

Grand Total All Awards = $3,299,240

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Award Number: U01CA271279

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/03/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2027

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer