Health TrialsbyHealthPanel

ADC-induced Neurotoxicity Treated With Duloxetine

ConditionSolid Tumour
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is effective in treating peripheral neuropathy caused by antibody-drug conjugate.

PURPOSE: This single arm phase II trial is studying duloxetine to see how well it works in treating peripheral neuropathy caused by antibody-drug conjugate in patients with cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged ≥ 18 years;

patients with a diagnosis confirmed by histological and/or cytological examination combined with imaging or ultrasound assessment of various advanced cancers;

consent to treatment;

ECOG score: 0 to 2;

Disqualifiers

peripheral neurotoxicity of grade 2 or higher has occurred with platinum-containing paclitaxel chemotherapy prior to prior ADC class administration, and the toxicity has not significantly worsened before or after ADC administration;

patients with severe diabetes mellitus and peripheral vascular disease;

patients with a history of neuropathy due to any type of nerve compression (e.g., carpal tunnel or tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy), severe depression, suicidal ideation, bipolar disorder, alcoholism, and severe eating disorders

active or uncontrolled serious infections (≥ CTCAE grade 2 infections) requiring administration of systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infections.

Trial design

Design model

Single group

Treatments tested in this trial

  • duloxetine

    Drug

    Patients were treated with duloxetine at a recommended dose of 40mg/day, increasing to a maximum dose of 60mg/day after seven days of non-significant discomfort.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: duloxetineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale

FACT-GOG-NTx scale neurotoxicity score (duloxetine treatment day 0 and 36) (4-point decrease in neurotoxicity score). The FACT-GOG-NTx scale, is a tool used to assess the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). This scale consists of 11 items, each item is scored on a 5-point scale (0=not at all, 4=very much), with a higher total score indicating more severe CIPN symptoms. In the study, the Minimal Clinically Important Difference (MCID) for the FACT-GOG-NTx scale was estimated to be between 1.38 and 3.68, which means that changes within this range are considered to be clinically meaningful. FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity.

Time frame
Day0 and Day36

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Adverse events (AEs), including type, incidence, grading (based on NCI-CTCAE V5.0 criteria), severity, duration, and relevance to the study medications.

Time frame
16 months
2

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale

The FACT-GOG-NTx scale, is a tool used to assess the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). This scale consists of 11 items, each item is scored on a 5-point scale (0=not at all, 4=very much), with a higher total score indicating more severe CIPN symptoms. In the study, the Minimal Clinically Important Difference (MCID) for the FACT-GOG-NTx scale was estimated to be between 1.38 and 3.68, which means that changes within this range are considered to be clinically meaningful. FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity.

Time frame
3 months
3

Numerical rating scale

A numeric pain rating scale is a single-item question that asks the patient to rate his or her pain on a scale of 0 to 10, using the anchors of "no pain" and "worse pain imaginable."

Time frame
Day0 and Day36
4

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Minimum Value: 0 (indicating the best possible health state) Maximum Value: 100 (indicating the worst possible health state) Higher scores indicate a worse quality of life or more severe symptoms. The scale includes both multi-item scales and single items to reflect various aspects of health-related quality of life. The scale consists of 30 questions measuring the patient's quality of life in terms of five functions (physical, daily living, cognitive, emotional and social), three symptoms (fatigue, pain, nausea and vomiting), and overall health, overall quality of life, and six other separate items (quality of sleep, appetite, diarrhoea, constipation, respiratory distress, and economic status).

Time frame
Day0 and Day36

Other outcomes

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov
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