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NCT03858153

Exercise and Nutrition Interventions During Chemotherapy K07

Completed Phase 2 Last updated 22 December 2025
What this trial tests

Phase 2 trial testing EXCAP Exercise in Neuropathy;Peripheral in 80 participants. Completed in 27 August 2025.

Timeline
15 April 2019
Primary endpoint
27 August 2025
27 August 2025

Quick facts

Lead sponsorUniversity of Rochester
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment80
Start date15 April 2019
Primary completion27 August 2025
Estimated completion27 August 2025
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Rochester

Who can join

18 and older, female only, with Neuropathy;Peripheral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Role of Nucleotide Excision Repair in Cisplatin-Induced Peripheral Neuropathy: Mechanism, Prevention, and Treatment.
    Acklin S, Xia F. · · 2021 · cited 13× · PMID 33671279 · DOI 10.3390/ijms22041975
  2. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system.
    Kleckner IR, Manuweera T, Lin PJ, Chung KH, et al · · 2024 · cited 10× · PMID 39304604 · DOI 10.1007/s00520-024-08855-y
  3. Preliminary evaluation of novel Bodily Attention Task to assess the role of the brain in chemotherapy-induced peripheral neurotoxicity (CIPN).
    Manuweera T, Wagenknecht A, Kleckner AS, Dorsey SG, et al · · 2024 · cited 7× · PMID 38070689 · DOI 10.1016/j.bbr.2023.114803

Verify or expand the search:

Other trials of EXCAP Exercise

Trials testing the same drug.

Other recruiting trials for Neuropathy;Peripheral

Currently open trials in the same condition.

Other University of Rochester trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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