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Chronic Neuropathy Following Chemotherapy

DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02654691
Acronym
DOLORISKCIPN
Enrollment
63
Registered
2016-01-13
Start date
2016-06-30
Completion date
2019-07-01
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Peripheral Nervous System Diseases

Keywords

Chemotherapy

Brief summary

This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination.

Detailed description

This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination. This is a collaboration and part of the data will be combined with other data in this collaboration

Interventions

None listed

Sponsors

University of Oxford
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
University of Dundee
CollaboratorOTHER
Mentis Cura
CollaboratorINDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University of Kiel
CollaboratorOTHER
Lund University
CollaboratorOTHER
Technion, Israel Institute of Technology
CollaboratorOTHER
University Ghent
CollaboratorOTHER
Neuroscience Technologies S.L.P
CollaboratorINDUSTRY
Danish Pain Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patients who have participated in a prospective questionnaire study

Exclusion criteria

* Not able to visit in person.

Design outcomes

Primary

MeasureTime frameDescription
Chemotherapy-induced Peripheral Neuropathy5-year follow-upFor case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy.
Chemotherapy-induced Neuropathic Pain5-year follow-upNeuropathic pain grading system. Neuropathic pain was graded as possible, probable, or definite in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018).

Secondary

MeasureTime frameDescription
Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).5-year follow-upNumber of patients with mild, moderate or severe symptoms of depression or anxiety. Patient Reported Outcomes Measurement Information System (PROMIS) used to assess if the patients has a mild, moderat or severe symptoms of depression/anxiety. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild , moderate or severe symptoms of depression or anxiety. A higher score indicates worse outcome. The minimum is no depression or anxiety and the maximum is severe depression or anxiey. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75
Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).5-year follow-upMean scores using HADS of all participants. The score for anxiety and depression indicate the sum of 7 questions, each graded from 0 to 3. This means that a person can score between 0 (minimum) and 21 (maximum) for either anxiety or depression. Higher score meaning more symptoms of a possible depression or anxiety.
Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).5-year follow-upNumber of patients with mild, moderate or severe fatigue. PROMIS used to assess if the patients has a mild, moderat or severe symptoms of fatique. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe symptoms of fatigue. The minimum is no fatigue (T-score\<50) and maximum severe fatigue (T-score ≥75). Higher scores mean a worse outcome. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75
Quality of Life Using EuroQol (EQ-5D).5-year follow-upThe participants were asked to provided a score from 1-100 regarding quality of life on the Quality of life using EuroQol (EQ-5D). Minimum score 0, maximum score 100. A higher score indicate better outcome
Personality Using the 10-item Personality Inventory (TIPI).5-year follow-upThe Personality using the 10-item Personality Inventory (TIPI). TIPI is divided in 5 parameters Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness. Minimum value is 2 and maximum value i 14. Higher scores indicate more Openness, Conscientiousness, Extraversion, Agreeableness and Emotional Stability
Personality Using the International Personality Item Pool (IPIP).5-year follow-upPersonality using the International Personality Item Pool (IPIP). A score were given from answering 10 questions regarding emotionel stability. Each question has 5 possible answers from 1 very inaccuate to 5 very accurate. Minimum combined value 10, maximum combined value 50. Higher score indicates worse outcome.
Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).5-year follow-upParticipants answered 13 question, which were each graded on a scale from 0-4 and combined to a sum scale.. The results are a mean score for all participants. The minimum value is 0 and the maximum value is 72. Higher scores indicate more Pain catastrophizing.
Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).5-year follow-upThe fibers in the cornea were scanned in one eye with the Heidelberg Retina Tomograph III laser-scanning confocal microscope (Heidelberg Engineering GmbH, Heidelberg, Germany). An automatic programme calculated the cornea nerve branches density (CNBD) and the cornea nerve fiber density (CNFD).
Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).5-year follow-upModified German Research Network on Neuropathic Pain QST protocol assessed sensory abnormalities after chemotherapy assessed with quantitative sensory testing (QST).
Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).5-year follow-upNumbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain. Patient Reported Outcomes Measurement Information System PROMIS used to assess if the patients has a mild, moderate or severe symptoms of pain interference. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe pain interference. The mimimum is no interference (T-score \<50) and maximum is Severe (T-score≥70)). Severe indicated more interference
Pain Descriptors by Douleur Neuropathique 4 (DN4).5-Year follow-upnumber of participants with a possible painful neuropathy with the Douleur Neuropathique 4DN4. Yes/no questions regarding symptoms and signs of neuropathic pain. In total the participants answered 7 questions. Each question is a yes or no and are combined to a sum score of number of positive answers. Minimum score is 0 and maximum score is 7. Higher score indicates larger probability of neuropathic Pain. A score of 3 or above indicates a possible painful neuropathy.
Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).5-Year follow-upThe results were given on a scale from 0-100 for each of the 5 dimensions on the Neuropathic Pain Symptom Inventory (NPSI). Higher scores indicate worse symptoms. The sum score is the sum divided by 5. Minimum score is 0 and maximum score is 100.
Neuropathy Using the Toronto Clinical Scoring System (TCSS).5-year follow-upThe Toronto Clinical Scoring System(TCSS), grades the severity of neuropathy and consists of 6 questions with the presence and description of symptoms and a 7-item clinical examination with reflexes in the lower extremities and a bedside sensory testing with pinprick, vibration, temperature, light touch and position of the 1st toe. The score ranges from 0-19. Higher score indicate worse outcome.
Neuropathy Using the Total Neuropathy Score.5-year follow-upThe TNScompact consists of 7 questions regarding sensory symptoms, motor symptoms, autonomic symptoms, pin sensation, vibrations sensitivity, strength and tendon reflexes graded from 0-4. The scores are combined and thus 0 being the lowest score possible and 28 being the highest score possible. A high score indicate severe neuropathy.
Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).5-year follow-upA cut-off ≥ 4/13 abnormal responses has been suggested as the cut-off to define polyneuropathy.
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor5-year follow-upMeasurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability).
Blood Samples DNA5-year follow-upNumbers indicate the number of participants, who had a blood sample collected. Potential gene associations in the development of painful neuropathy will be assessed together with other samples in the DOLORisk collaboration. The results here present the number of subjects who had a DNA blood sample taken.
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory5-year follow-upMeasurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability).

Countries

Denmark

Participant flow

Participants by arm

ArmCount
Chemotherapy
Patients treated with docetaxel or oxaliplatin.
63
Total63

Baseline characteristics

CharacteristicChemotherapy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
27 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
Age, Continuous63.6 years
STANDARD_DEVIATION 9.1
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Denmark
63 participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
23 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 63
other
Total, other adverse events
0 / 63
serious
Total, serious adverse events
0 / 63

Outcome results

Primary

Chemotherapy-induced Neuropathic Pain

Neuropathic pain grading system. Neuropathic pain was graded as possible, probable, or definite in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018).

Time frame: 5-year follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChemotherapyChemotherapy-induced Neuropathic Pain19 Participants
Primary

Chemotherapy-induced Peripheral Neuropathy

For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy.

Time frame: 5-year follow-up

ArmMeasureValue (NUMBER)
ChemotherapyChemotherapy-induced Peripheral Neuropathy21 participants
Secondary

Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).

Mean scores using HADS of all participants. The score for anxiety and depression indicate the sum of 7 questions, each graded from 0 to 3. This means that a person can score between 0 (minimum) and 21 (maximum) for either anxiety or depression. Higher score meaning more symptoms of a possible depression or anxiety.

Time frame: 5-year follow-up

ArmMeasureGroupValue (MEAN)Dispersion
ChemotherapyAnxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).Anxiety4.38 score on a scaleStandard Deviation 3.76
ChemotherapyAnxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).Depression2.40 score on a scaleStandard Deviation 2.34
Secondary

Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).

Number of patients with mild, moderate or severe symptoms of depression or anxiety. Patient Reported Outcomes Measurement Information System (PROMIS) used to assess if the patients has a mild, moderat or severe symptoms of depression/anxiety. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild , moderate or severe symptoms of depression or anxiety. A higher score indicates worse outcome. The minimum is no depression or anxiety and the maximum is severe depression or anxiey. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75

Time frame: 5-year follow-up

ArmMeasureGroupValue (NUMBER)
ChemotherapyAnxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).Anxiety12 participants
ChemotherapyAnxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).Depression12 participants
ChemotherapyAnxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).Anxiety or Depression16 participants
Secondary

Blood Samples DNA

Numbers indicate the number of participants, who had a blood sample collected. Potential gene associations in the development of painful neuropathy will be assessed together with other samples in the DOLORisk collaboration. The results here present the number of subjects who had a DNA blood sample taken.

Time frame: 5-year follow-up

Population: Numbers indicate the number of participants, who had a blood sample collected. Not analyzed separately

ArmMeasureValue (NUMBER)
ChemotherapyBlood Samples DNA58 participants
Secondary

Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).

Number of patients with mild, moderate or severe fatigue. PROMIS used to assess if the patients has a mild, moderat or severe symptoms of fatique. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe symptoms of fatigue. The minimum is no fatigue (T-score\<50) and maximum severe fatigue (T-score ≥75). Higher scores mean a worse outcome. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75

Time frame: 5-year follow-up

Population: Numbers given is patients with mild, moderate or severe fatigue.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChemotherapyFatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).25 Participants
Secondary

Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).

The fibers in the cornea were scanned in one eye with the Heidelberg Retina Tomograph III laser-scanning confocal microscope (Heidelberg Engineering GmbH, Heidelberg, Germany). An automatic programme calculated the cornea nerve branches density (CNBD) and the cornea nerve fiber density (CNFD).

Time frame: 5-year follow-up

Population: Missing data in 10 patients

ArmMeasureGroupValue (MEAN)Dispersion
ChemotherapyMorphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).CNBD30.5 units/mm2Standard Deviation 13.5
ChemotherapyMorphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).CNFD22.8 units/mm2Standard Deviation 7.8
Secondary

Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor

Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten (RRP) makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).

Time frame: 5-year follow-up

Population: Motor recordings from participants, refractoriness at 2.5 ms, superexcitability and subexcitability

ArmMeasureGroupValue (MEAN)Dispersion
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: MotorRefractoriness at 2.5 ms18.8 percentage of 100%Standard Error 1.9
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: MotorSuperexcitability21.8 percentage of 100%Standard Error 0.8
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: MotorSubexcitability16.2 percentage of 100%Standard Error 0.7
Secondary

Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor

Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability).

Time frame: 5-year follow-up

Population: Motor recordings from participants, relative refractory period

ArmMeasureValue (MEAN)Dispersion
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor3.0 msStandard Error 1
Secondary

Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory

Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).

Time frame: 5-year follow-up

Population: Sensory recordings from participants, refractoriness at 2.5 ms, superexcitability and subexcitability

ArmMeasureGroupValue (MEAN)Dispersion
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: SensoryRefractoriness at 2.5 ms11.0 percentage of 100%Standard Error 1.9
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: SensorySuperexcitability17.4 percentage of 100%Standard Error 0.8
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: SensorySubexcitability10.9 percentage of 100%Standard Error 0.8
Secondary

Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory

Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability).

Time frame: 5-year follow-up

Population: Sensory recordings from participants, the relative refractory period

ArmMeasureValue (MEAN)Dispersion
ChemotherapyNeuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory3.1 msStandard Error 1
Secondary

Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).

A cut-off ≥ 4/13 abnormal responses has been suggested as the cut-off to define polyneuropathy.

Time frame: 5-year follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChemotherapyNeuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).21 Participants
Secondary

Neuropathy Using the Toronto Clinical Scoring System (TCSS).

The Toronto Clinical Scoring System(TCSS), grades the severity of neuropathy and consists of 6 questions with the presence and description of symptoms and a 7-item clinical examination with reflexes in the lower extremities and a bedside sensory testing with pinprick, vibration, temperature, light touch and position of the 1st toe. The score ranges from 0-19. Higher score indicate worse outcome.

Time frame: 5-year follow-up

Population: Results wer missing in 4 participants.

ArmMeasureValue (MEAN)Dispersion
ChemotherapyNeuropathy Using the Toronto Clinical Scoring System (TCSS).4.8 score on a scaleStandard Deviation 3.2
Secondary

Neuropathy Using the Total Neuropathy Score.

The TNScompact consists of 7 questions regarding sensory symptoms, motor symptoms, autonomic symptoms, pin sensation, vibrations sensitivity, strength and tendon reflexes graded from 0-4. The scores are combined and thus 0 being the lowest score possible and 28 being the highest score possible. A high score indicate severe neuropathy.

Time frame: 5-year follow-up

Population: The results were missing for 5 participants.

ArmMeasureValue (MEAN)Dispersion
ChemotherapyNeuropathy Using the Total Neuropathy Score.3.9 score on a scaleStandard Deviation 3
Secondary

Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).

Participants answered 13 question, which were each graded on a scale from 0-4 and combined to a sum scale.. The results are a mean score for all participants. The minimum value is 0 and the maximum value is 72. Higher scores indicate more Pain catastrophizing.

Time frame: 5-year follow-up

ArmMeasureValue (MEAN)Dispersion
ChemotherapyPain Catastrophizing Using the Pain Catastrophizing Scale(PCS).7.6 score on a scaleStandard Deviation 9.4
Secondary

Pain Descriptors by Douleur Neuropathique 4 (DN4).

number of participants with a possible painful neuropathy with the Douleur Neuropathique 4DN4. Yes/no questions regarding symptoms and signs of neuropathic pain. In total the participants answered 7 questions. Each question is a yes or no and are combined to a sum score of number of positive answers. Minimum score is 0 and maximum score is 7. Higher score indicates larger probability of neuropathic Pain. A score of 3 or above indicates a possible painful neuropathy.

Time frame: 5-Year follow-up

Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. The result are the number of participants with a possible painful neuropathy with the DN4.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChemotherapyPain Descriptors by Douleur Neuropathique 4 (DN4).13 Participants
Secondary

Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).

The results were given on a scale from 0-100 for each of the 5 dimensions on the Neuropathic Pain Symptom Inventory (NPSI). Higher scores indicate worse symptoms. The sum score is the sum divided by 5. Minimum score is 0 and maximum score is 100.

Time frame: 5-Year follow-up

Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. The result are the score of participants with a neuropathic pain.

ArmMeasureValue (MEAN)Dispersion
ChemotherapyPain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).23.3 score on a scaleStandard Deviation 20.9
Secondary

Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).

Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain. Patient Reported Outcomes Measurement Information System PROMIS used to assess if the patients has a mild, moderate or severe symptoms of pain interference. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe pain interference. The mimimum is no interference (T-score \<50) and maximum is Severe (T-score≥70)). Severe indicated more interference

Time frame: 5-year follow-up

Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChemotherapyPain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).17 Participants
Secondary

Personality Using the 10-item Personality Inventory (TIPI).

The Personality using the 10-item Personality Inventory (TIPI). TIPI is divided in 5 parameters Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness. Minimum value is 2 and maximum value i 14. Higher scores indicate more Openness, Conscientiousness, Extraversion, Agreeableness and Emotional Stability

Time frame: 5-year follow-up

Population: Answers are missing for 1 participant.

ArmMeasureGroupValue (MEAN)Dispersion
ChemotherapyPersonality Using the 10-item Personality Inventory (TIPI).Openness5.3 units on a scaleStandard Deviation 1.1
ChemotherapyPersonality Using the 10-item Personality Inventory (TIPI).Extraversion4.5 units on a scaleStandard Deviation 1.5
ChemotherapyPersonality Using the 10-item Personality Inventory (TIPI).Agreeableness4.9 units on a scaleStandard Deviation 1.1
ChemotherapyPersonality Using the 10-item Personality Inventory (TIPI).Conscientiousness5.2 units on a scaleStandard Deviation 1.1
ChemotherapyPersonality Using the 10-item Personality Inventory (TIPI).Emotional Stability5.2 units on a scaleStandard Deviation 1.3
Secondary

Personality Using the International Personality Item Pool (IPIP).

Personality using the International Personality Item Pool (IPIP). A score were given from answering 10 questions regarding emotionel stability. Each question has 5 possible answers from 1 very inaccuate to 5 very accurate. Minimum combined value 10, maximum combined value 50. Higher score indicates worse outcome.

Time frame: 5-year follow-up

Population: Results from 1 participant were missing

ArmMeasureValue (MEAN)Dispersion
ChemotherapyPersonality Using the International Personality Item Pool (IPIP).34.3 score on a scaleStandard Deviation 7.6
Secondary

Quality of Life Using EuroQol (EQ-5D).

The participants were asked to provided a score from 1-100 regarding quality of life on the Quality of life using EuroQol (EQ-5D). Minimum score 0, maximum score 100. A higher score indicate better outcome

Time frame: 5-year follow-up

ArmMeasureValue (MEAN)Dispersion
ChemotherapyQuality of Life Using EuroQol (EQ-5D).78.4 units on a scaleStandard Deviation 17.2
Secondary

Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).

Modified German Research Network on Neuropathic Pain QST protocol assessed sensory abnormalities after chemotherapy assessed with quantitative sensory testing (QST).

Time frame: 5-year follow-up

Population: Patients with an abnormal value indicating loss of function

ArmMeasureGroupValue (NUMBER)
ChemotherapySensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).Abnormal thermal detection11 participants
ChemotherapySensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).Abnormal vibration detection18 participants
ChemotherapySensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).Abnormal mechanical detection threshold11 participants
ChemotherapySensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).Abnormal paradoxical heat sensation16 participants
ChemotherapySensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).Abnormal mechanical pain threshold8 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026