Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors

NCT ID: NCT05378256

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-03-11

Brief Summary

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Vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with R-CHOP. The investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in VIPN occurrence.

Detailed Description

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Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Conditions

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Lymphoma Peripheral Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Clinical scales of CIPN

Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Group Type OTHER

Clinical scales of CIPN

Intervention Type OTHER

Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Interventions

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Clinical scales of CIPN

Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of indolent or aggressive B/T NHL confirmed by biopsy and requiring chemotherapy after PCR decision including vincristine, RCHOP/CHOP protocol or CHOEP
* Accept to participate in the study
* Age \> 18 year
* Able and willing to provide informed consent
* Affiliated to a social security system

Exclusion Criteria

* Life-threatening emergency requiring chemotherapy in extreme urgency
* Neuro-meningeal damage at diagnosis
* Protected person (under guardianship or curators)
* Person under court protection
* Pregnant or breastfeeding woman
* Persons deprived of liberty by judicial or administrative decision
* Persons under forced psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Persons unable to express their consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal AUZOU, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

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CHR Orléans

Orléans, , France

Site Status

Countries

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France

References

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Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77. doi: 10.1016/j.critrevonc.2011.04.012. Epub 2011 Sep 10.

Reference Type BACKGROUND
PMID: 21908200 (View on PubMed)

Caccia MR, Comotti B, Ubiali E, Lucchetti A. Vincristine polyneuropathy in man. A clinical and electrophysiological study. J Neurol. 1977 Aug 18;216(1):21-6. doi: 10.1007/BF00312811.

Reference Type BACKGROUND
PMID: 72789 (View on PubMed)

Casey EB, Fullerton PM, Jelliffe AW. Vincristine neurotoxicity: a clinical and electrophysiological study of eighteen patients. Clin Sci. 1970 Apr;38(4):23P-24P. doi: 10.1042/cs038023pb. No abstract available.

Reference Type BACKGROUND
PMID: 5428794 (View on PubMed)

Casey EB, Jellife AM, Le Quesne PM, Millett YL. Vincristine neuropathy. Clinical and electrophysiological observations. Brain. 1973;96(1):69-86. doi: 10.1093/brain/96.1.69. No abstract available.

Reference Type BACKGROUND
PMID: 4348690 (View on PubMed)

Other Identifiers

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CHRO-2021-09

Identifier Type: -

Identifier Source: org_study_id

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