CancerPhase 4NCT07022938
Nutritional Supplement for Treating Chemotherapy Induced Neuropathy
A Phase 4 study testing Epineuron in people with Cancer and Neuropathy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Administration of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Neuropathy, Chemotherapy Induced Pain Neuropathy
- What is being tested?
- Epineuron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2021to 15 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed patients with cancer that have not received yet their treatment
- Patients that will be treated with platinum agents or taxanes
Who cannot join
- Not receiving dietary supplement
- Have already neuropathy
- Have already started chemotherapy
- Patients with uncontrolled diabetes
- -- Patients with chronic kidney disease
- Patiens with recent cardiovascular incident
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a Tablet Containing Palmitoyethanolamide, Alpha Lipoic Acid, Vitamin B12, Vitamin B6 , Vitamin B1, Nicotinamide, Magnesium, Zinc, Vitamin E, and Superoxide of Dismutase in Individuals Receiving Chemotherapy
Administration of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
Read the detailed description
Investigation of effectiveness and safety of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
- Conditions
- Cancer, Neuropathy, Chemotherapy Induced Pain Neuropathy, Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- Epineuron, Placebo Tablets
- Keywords
- cancer, neuropathy, chemotherapy induced neuropathy, supplement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpineuronDietary supplement
Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet
Placebo TabletsDietary supplement
placebo tablet without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Epineuron | Active comparator | Administration of a nutritional supplement with Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet Receives: Dietary Supplement: Epineuron |
| Placebo | Placebo comparator | similar tablet without active ingredients Receives: Dietary Supplement: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Symptom Inventory
scale for neuropathic pain symptoms. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. In addition, we propose to derive five subscores corresponding to the mean scores of the items belonging to each of the five factors identified in the factor analysis. three questions based on clinical examination to evaluate the intensity of pain evoked by brushing, pressure, cold or warm stimuli in the painful area on four-point categorical scales (absent, mild, moderate, severe). Clinical examination of evoked pain was standardized: tactile allodynia was evaluated with a soft brush (three movements), pressure allodynia was evoked by blunt pressure with a finger at a pressure that does not provoke pain in a normal area and glass tubes filled with hot (38-408C) or cold (22-248C) water were used to evaluate thermal allodynia.
Measured: 6 months
PAIN Detect score
score for neuropathic pain, higher values indicate that the pain is neuropathic. A Pain DETECT score between-1 and 38 indicates the likelihood of a neuropathic pain component
Measured: 6 months
Secondary outcomes (3)
Visual Analogue scale
scale for pain , higher values indicate more severity of pain, scale 0-100
Measured: 6 months
Nerve conduction velocity
neurophysiological assessment of sural nerve
Measured: 6months
Vibration perception threshold
Vibration perception threshold was measured with biothesiometer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Nov 2021
- Primary completion31 Jan 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022938
- Sponsor's protocol ID
- 2606/25.1.2021
- Status last verified
- Dec 2025
- First submitted
- 8 Jun 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data privacy of participants
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Tablet Containing Palmitoyethanolamide, Alpha Lipoic Acid, Vitamin B12, Vitamin B6 , Vitamin B1, Nicotinamide, Magnesium, Zinc, Vitamin E, and Superoxide of Dismutase in Individuals Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT07022938
- Acronym / sponsor ID
- 2606/25.1.2021
- Conditions
- Cancer, Neuropathy, Chemotherapy Induced Pain Neuropathy, Chemotherapy-Induced Peripheral Neuropathy
- Keywords
- cancer, neuropathy, chemotherapy induced neuropathy, supplement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administration of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
Detailed description
Investigation of effectiveness and safety of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy
| Arm | Type | Receives |
|---|---|---|
| Epineuron | Active comparator | Dietary Supplement: EpineuronAdministration of a nutritional supplement with Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Tabletssimilar tablet without active ingredients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed patients with cancer that have not received yet their treatment
- Patients that will be treated with platinum agents or taxanes
Key exclusion criteria (6 listed)
- Not receiving dietary supplement
- Have already neuropathy
- Have already started chemotherapy
- Patients with uncontrolled diabetes
- -- Patients with chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpineuronPalmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet | Dietary supplement | Epineuron |
| Placebo Tabletsplacebo tablet without active ingredients | Dietary supplement | Placebo |
Primary outcome
Neuropathic Pain Symptom Inventory
Time frame: 6 months
scale for neuropathic pain symptoms. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. In addition, we propose to derive five subscores corresponding to the mean scores of the items belonging to each of the five factors identified in the factor analysis. three questions based on clinical examination to evaluate the intensity of pain evoked by brushing, pressure, cold or warm stimuli in the painful area on four-point categorical scales (absent, mild, moderate, severe). Clinical examination of evoked pain was standardized: tactile allodynia was evaluated with a soft brush (three movements), pressure allodynia was evoked by blunt pressure with a finger at a pressure that does not provoke pain in a normal area and glass tubes filled with hot (38-408C) or cold (22-248C) water were used to evaluate thermal allodynia.
PAIN Detect score
Time frame: 6 months
score for neuropathic pain, higher values indicate that the pain is neuropathic. A Pain DETECT score between-1 and 38 indicates the likelihood of a neuropathic pain component
3 secondary outcomes
Visual Analogue scale
Time frame: 6 months
Nerve conduction velocity
Time frame: 6months
Vibration perception threshold
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. Data privacy of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epineuron in people with Cancer and Neuropathy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Symptom Inventory (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.