Effekten af elektrostimulations- og kompressionsapplikationer på neuropatisymptomer og livskvalitet i behandlingen af kemoterapi-induceret perifer neuropati hos gastrointestinale systemkancerpatienter, der modtager oxaliplatinbaseret behandling
Effekten af elektrostimulering og kompressionsapplikationer på neuropatisymptomer og livskvalitet i behandlingen af kemoterapi-induceret perifer neuropati hos patienter med gastrointestinal cancer, der modtager oxaliplatin-baseret behandling
Denne forskning blev udført for at evaluere effekten af elektrostimulering og kompressionsapplikationer på sværhedsgraden, antallet og smerteniveauerne af neuropatisymptomer samt livskvaliteten for patienter med metastatisk gastrointestinal cancer, der modtager oxaliplatin-baseret behandling, i behandlingen af kemoterapi-induceret perifer neuropati.
Studiepopulationen bestod af patienter med gastrointestinal cancer mellem 2025-2026. Dataindsamlingsværktøjer blev administreret til patienter, der opfyldte inklusionskriterierne og udviklede kemoterapi-induceret perifer neuropati. Patienterne blev derefter stratificeret efter alder og køn og tildelt til "kontrollgruppe, elektrostimuleringsgruppe, kompressionsgruppe og elektrostimulering+kompressionsgruppe" ved hjælp af blokrandomisering. Statistisk styrkeanalyse fastsatte det samlede antal deltagere i studiet til 140 patienter, med 35 patienter i hver gruppe. Patienter i kontrollen havde gavn af klinikkens standardprocedurer og modtog ingen intervention.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Sivas
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Sivas, Sivas, Tyrkiet (Türkiye), 58010
- Sivas Cumhuriyet University Health Services Application and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- At være 18 år eller ældre,
- At have en diagnose af metastatisk gastrointestinal cancer (mave, bugspytkirtel, tyktarm, endetarm),
- At være planlagt til at modtage 6 cyklusser af kemoterapi,
- At have modtaget 1 cyklus af oxaliplatin-baseret kemoterapi (FOLFOX og FOLFİRİNOX),
- Ikke at have en diagnosticeret psykisk lidelse,
- Ikke at have hudproblemer i de områder, hvor TENS og kompressionsapplikationer vil blive udført,
- At have mundtligt og skriftligt godkendt samtykkeerklæringen efter at være blevet informeret og forklaret om undersøgelsen.
Eksklusionskriterier:
- At have tidligere modtaget oxaliplatin-baseret behandling (monoterapi eller kombination),
- At have en pacemaker,
- At have en historie med hudfølsomhed i hænder og fødder,
- At have modtaget eller i øjeblikket modtager et andet neurotoksiskt kemoterapeutisk middel end oxaliplatin-baseret behandling,
- At have udviklet perifer neuropati på grund af andre årsager end kemoterapi [tumorkompression, ernæringsmæssige mangler, infektioner eller større systemisk sygdom (diabetes mellitus osv.)].
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: TENS Group
Participants received the TENS intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care.
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TENS was delivered using the F. Bosch FB2405 TENS+EMS dual-channel device with four 5 × 5-cm surface electrodes placed bilaterally over PC6 and KI1.
Program 4 provided a modulated pulse rate of 2-60 Hz and a pulse width of 156-260 microseconds.
The device output was adjustable from 0-80 mA per channel into a 500-Ω load, but no fixed mA value was used.
Intensity was individually titrated to a strong, comfortable, non-painful sensory level without visible muscle contraction.
Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion.
Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.
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Eksperimentel: Compression group
Participants received the compression intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care.
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Bilateral compression of the hands and feet was applied using Beybi Sensitive surgical gloves one size smaller than the participant's measured glove size and knee-high Varimed CCL II graduated compression stockings providing 23-32 mmHg.
Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion.
Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.
All applications were individually fitted and directly supervised by the same research nurse.
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Eksperimentel: Sequential TENS Plus Compression Group
Participants received TENS followed by compression at each scheduled intervention session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care.
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Participants received 90 minutes of TENS followed immediately by 90 minutes of bilateral hand-and-foot compression, using the same devices, parameters, electrode placement, gloves, and stockings as in the monotherapy groups.
TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion.
After TENS was stopped and the electrodes were removed, compression was applied during the remaining 60 minutes of the infusion and for 30 minutes afterward.
The total sequential intervention lasted 180 minutes.
Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.
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Ingen indgriben: Usual Care Control Group
Participants received usual care from Cycle 2 through Cycle 6 and received no study-specific TENS or compression intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Baseline-Adjusted EORTC QLQ-CIPN20 Total Score Trajectory Across T1-T4
Tidsramme: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire assessing sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores are linearly transformed to a 0-100 scale, with higher scores indicating greater CIPN-related symptom burden. The primary outcome was the baseline-adjusted post-baseline trajectory of the EORTC QLQ-CIPN20 total score across T1-T4. The assessments before Cycles 3-6 (T1-T4) were modelled jointly, with the score obtained before Cycle 2 (T0) included as the baseline covariate. The overall Group-by-Time interaction constituted the primary treatment-effect test. Baseline-adjusted between-group contrasts at T4 constituted the primary endpoint pairwise comparisons. |
Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Baseline-Adjusted EORTC QLQ-C30 Scale Score Trajectories Across T1-T4
Tidsramme: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire assessing health-related quality of life in patients with cancer. It includes five functional scales, three symptom scales, a global health status/quality-of-life scale, and six single-item symptom measures. Scores are linearly transformed to a 0-100 scale. Higher functional and global health status scores indicate better functioning and quality of life, whereas higher symptom scores indicate greater symptom burden. For each EORTC QLQ-C30 scale, the assessments before Cycles 3-6 (T1-T4) were modelled jointly, with the corresponding score obtained before Cycle 2 (T0) included as the baseline covariate. The Group-by-Time interaction was evaluated as a secondary treatment-period effect. |
Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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NCI-CTCAE v5.0 Peripheral Sensory Neuropathy Grade Across T1-T4
Tidsramme: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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Chemotherapy-induced peripheral sensory neuropathy severity was assessed by a medical oncologist using the clinician-rated National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0). Peripheral sensory neuropathy was graded from 0 to 4, with higher grades indicating greater severity and functional impairment. Because all participants were classified as Grade 2 at T0 and sparse or zero cells prevented stable repeated-measures categorical modelling, grade distributions were compared among the randomized groups separately at each post-baseline treatment-period assessment from T1 to T4. |
Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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DN4 Total Score Trajectory and DN4-Defined Neuropathic Pain Positivity Across T1-T4
Tidsramme: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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Neuropathic pain was assessed using the Douleur Neuropathique en 4 Questions (DN4), a 10-item clinician-administered instrument comprising seven symptom-interview items and three clinical-examination items. The total score ranges from 0 to 10, with higher scores indicating a greater number of neuropathic pain features. A score of 4 or higher was classified as DN4-defined neuropathic pain positivity. The DN4 total scores obtained before Cycles 3-6 (T1-T4) were modelled jointly, with the DN4 total score obtained before Cycle 2 (T0) included as the baseline covariate. The Group-by-Time interaction was evaluated as a continuous secondary treatment-period effect. DN4-defined neuropathic pain positivity was compared among the randomized groups separately at each T1-T4 assessment. |
Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Exploratory QLQ-CIPN20 Total Scores at 6-Month Follow-up
Tidsramme: At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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The EORTC QLQ-CIPN20 total score was assessed at the prespecified 6-month follow-up.
Scores range from 0 to 100, with higher scores indicating greater CIPN-related symptom burden.
This assessment was analyzed separately as an exploratory follow-up outcome and was not included in the primary T0-T4 treatment-period analysis.
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At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Exploratory EORTC QLQ-C30 Scale Scores at 6-Month Follow-up
Tidsramme: At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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EORTC QLQ-C30 scale scores were assessed exploratorily at the prespecified long-term follow-up.
Scores range from 0 to 100.
Higher functional and global health status scores indicate better functioning and quality of life, whereas higher symptom scores indicate greater symptom burden.
This assessment was conducted to examine participants' health-related quality-of-life status after the extended follow-up interval.
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At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Exploratory NCI-CTCAE v5.0 Peripheral Sensory Neuropathy Grade at 6-Month Follow-up
Tidsramme: At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Peripheral sensory neuropathy severity was assessed exploratorily at the prespecified long-term follow-up using NCI-CTCAE v5.0.
Neuropathy is graded from 0 to 5, with higher grades indicating greater severity and functional impairment.
This assessment was conducted to examine participants' neuropathy status after the extended follow-up interval.
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At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Exploratory DN4 Total Score and Neuropathic Pain Positivity at 6-Month Follow-up
Tidsramme: At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Neuropathic pain was assessed exploratorily at the prespecified long-term follow-up using the DN4.
Total scores range from 0 to 10, with higher scores indicating more neuropathic pain features.
A score of 4 or higher was classified as positive for neuropathic pain.
This assessment was conducted to examine participants' neuropathic pain status after the extended follow-up interval.
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At 6 months after completion of Cycle 6 (T5 exploratory follow-up assessment); each chemotherapy cycle lasted 14 days.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Şerife KARAGÖZOĞLU, Proff., Cumhuriyet University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CumhuriyetU-SBE-SÖ-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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