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NCT03858153
Exercise and Nutrition Interventions During Chemotherapy K07
Phase 2 trial testing EXCAP Exercise in Neuropathy;Peripheral in 80 participants. Completed in 27 August 2025.
27 August 2025
Quick facts
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 80 |
| Start date | 15 April 2019 |
| Primary completion | 27 August 2025 |
| Estimated completion | 27 August 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- EXCAP Exercise
- Nutrition Education
Conditions studied
- Neuropathy;Peripheral — all drugs for Neuropathy;Peripheral →
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):
-
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 -
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 -
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:
- PubMed search for NCT03858153
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EXCAP Exercise
Trials testing the same drug.
- NCT05452902 — Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21 · Phase 2 · terminated
- NCT03021174 — Exercise and Nutrition Interventions During Chemotherapy · NA · completed
Other recruiting trials for Neuropathy;Peripheral
Currently open trials in the same condition.
- NCT07427537 — Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients · NA · recruiting
- NCT06912646 — Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain · NA · recruiting
- NCT06471517 — Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation · NA · recruiting
- NCT05980169 — The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy · NA · active not recruiting
- NCT06121232 — Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Mar · NA · active not recruiting
Other University of Rochester trials
Trials by the same sponsor.
- NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
- NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
- NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
- NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
- NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03858153 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Rochester
- Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03858153.
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