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

C

Centre Hospitalier Régional d'Orléans

Status

Completed

Conditions

Peripheral Neuropathy
Lymphoma

Treatments

Other: Clinical scales of CIPN

Study type

Interventional

Funder types

Other

Identifiers

NCT05378256
CHRO-2021-09

Details and patient eligibility

About

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.

Full description

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Clinical scales of CIPN
Other group
Description:
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).
Treatment:
Other: Clinical scales of CIPN

Trial contacts and locations

1

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Central trial contact

Pascal AUZOU, Dr

Data sourced from clinicaltrials.gov

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