NeuropathyPhase 3NEUROXAPOLNCT01775449
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
A Phase 3 study testing Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines in people with Neuropathy and Digestive Cancer System, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathy, Digestive Cancer System
- What is being tested?
- Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2013to 6 Jan 2015
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patients affected by gastrointestinal cancer, without cytotoxic neurotoxic chemotherapy, had to receive FOLFOX 4 chemotherapy (folinic acid + 5-FU + oxaliplatin) in the adjuvant, neoadjuvant or palliative situation with an expected period of 8 cures of treatment or 4 months.
- Patients having given their written, free and informed consent
- Patient's members of a social security scheme
- Patients not having participated in another clinical trial within 15 days before its baseline (possibility of participating and / or participate in an observational trial)
- Effective contraception for patients, male or female, in childbearing age.
- Neutrophils > 2.109/L and/or platelet > 100.109/L before the first treatment cycle
Who cannot join
- - Patient which cannot receive FOLFOX 4 whatever the reason
- Patients < 18 years old and > 70 years old
- Malnourished patient (French National Authority for Health, 2003)
- Patients with all or part of an upper limb amputation
- Diabetic patient
- Patients with neuropathy
Show all 19Show fewer
- Oral nutrition impossible
- Painful procedures scheduled after the baseline (e.g. surgical excision)
- Neurological disorders (e.g. parkinsonism, stroke ...)
- Alcohol consumption upper 3 alcohol units (30 g) for men and upper 2 alcohol units (20 g) for women
- Patients having already received cytotoxic neurotoxic chemotherapy (taxanes, platinum salts or vinca alkaloids)
- Patients treated for another cancer within 5 years except basal cell skin carcinoma or in situ cervical cancer
- Any unbalanced progressive disease (hepatic failure, renal insufficiency (creatinine clearance <30 mL / min), respiratory failure, congestive heart failure, myocardial infarction within the past 6 months ...)
- Patients requiring Ca2 + or Mg2 + perfusions
- Hypersensitivity or allergy known about one of study product's component
- Pregnant woman or breastfeeding woman
- Legal disability (person deprived of liberty or under guardianship)
- Patients for psychological, social, family or geographical reasons can not be monitored regularly and / or be compliant with the requirements of the study
- Patients already included in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles.
To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals.
So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.
Read the detailed description
This is a prospective, single-center, controlled and interventional study with two parallel groups randomized in single-blind.
After obtaining informed consent, all included patients will be randomized, either:
- in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral alimentation without polyamines), associated to predefined menus low in polyamines, according to the chemotherapy cycle and for 107 days
- in the control group with a normal polyamines containing diet: 1 can per day of Polydol® associated with predefined menus with normal average in polyamines and for 107 days.
Randomization will be performed by considering stratification on the tumor presence or not, because it is one of the polyamines source (Linsalata and Russo, 2008) and could influence the results in the study.
In addition, patient compliance will be collected in the case report form all along the study, and included in the statistical analysis of the study.
- Conditions
- Neuropathy, Digestive Cancer System
- Being tested
- Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
- Keywords
- Anticancer drug;, Oxaliplatin;, Digestive cancer system, Acute oxaliplatin-induced hypersensitivity, Hyperalgesia;, Allodynia;, Dysesthesia, Polyamines depleted diet
- Medical subject headings
- Digestive System Neoplasms, Hyperalgesia, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyaminesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| polyamines depleted diet | Experimental | • in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral alimentation without polyamines), associated to predefined menus low in polyamines, according to the chemotherapy cycle and for 107 days Receives: Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines |
| normal polyamines containing diet | Other | • in the control group with a normal polyamines containing diet: 1 can per day of Polydol® associated with predefined menus with normal average in polyamines and for 107 days. Receives: Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold pain thresholds
Measured: day 42
Secondary outcomes (10)
Cold pain thresholds
Measured: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Heat pain thresholds
Measured: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
DN4 (Douleur Neuropathique en 4 Questions) scores
Measured: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
HADS (Hospital Anxiety and Depression Scale) score
Measured: day -7, 0, 14, 28, 42, 98, 154
Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events))
Measured: day 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Cancer response
Measured: day 154
Oxaliplatin dose intensity
Measured: day 154
Erythrocyte polyamine levels
Measured: day -7, 0, 14, 28, 42, 70, 98
NPSI ( Neuropathic Pain Symptom Inventory)scores
Measured: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
QLQ-C30 (Quality of Life questionnaire C30)scores
Measured: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study start2 Feb 2013
- Primary completion6 Jan 2015
- Study completion6 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, Ligue contre le cancer - Auvergne
- Responsible party
- Sponsor
- Investigators
- Denis PEZET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775449
- Sponsor's protocol ID
- CHU-0137
- Other IDs
- 2011-A00911-40
- Acronym
- NEUROXAPOL
- Status last verified
- Jul 2016
- First submitted
- 7 Jan 2013
- Last updated
- 11 Jul 2017
- Results posted
- No
Publications
Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.
PubMed 25833669
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
- ClinicalTrials.gov ID
- NCT01775449
- Acronym / sponsor ID
- NEUROXAPOL / CHU-0137
- Conditions
- Neuropathy, Digestive Cancer System
- Keywords
- Anticancer drug;, Oxaliplatin;, Digestive cancer system, Acute oxaliplatin-induced hypersensitivity, Hyperalgesia;, Allodynia;, Dysesthesia, Polyamines depleted diet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Apicil, Ligue contre le cancer - Auvergne
- Study start
- 2 Feb 2013 (actual)
- Primary completion
- 6 Jan 2015 (actual)
- Study completion
- 6 Jan 2015 (actual)
- First posted
- 25 Jan 2013 (estimated)
- 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.
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles.
To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals.
So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.
Detailed description
This is a prospective, single-center, controlled and interventional study with two parallel groups randomized in single-blind.
After obtaining informed consent, all included patients will be randomized, either:
- in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral alimentation without polyamines), associated to predefined menus low in polyamines, according to the chemotherapy cycle and for 107 days
- in the control group with a normal polyamines containing diet: 1 can per day of Polydol® associated with predefined menus with normal average in polyamines and for 107 days.
Randomization will be performed by considering stratification on the tumor presence or not, because it is one of the polyamines source (Linsalata and Russo, 2008) and could influence the results in the study.
In addition, patient compliance will be collected in the case report form all along the study, and included in the statistical analysis of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyamines depleted diet | Experimental | Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines• in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral alimentation without polyamines), associated to predefined menus low in polyamines, according to the chemotherapy cycle and for 107 days |
| normal polyamines containing diet | Other | Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines• in the control group with a normal polyamines containing diet: 1 can per day of Polydol® associated with predefined menus with normal average in polyamines and for 107 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Patients affected by gastrointestinal cancer, without cytotoxic neurotoxic chemotherapy, had to receive FOLFOX 4 chemotherapy (folinic acid + 5-FU + oxaliplatin) in the adjuvant, neoadjuvant or palliative situation with an expected period of 8 cures of treatment or 4 months.
- Patients having given their written, free and informed consent
- Patient's members of a social security scheme
- Patients not having participated in another clinical trial within 15 days before its baseline (possibility of participating and / or participate in an observational trial)
- Effective contraception for patients, male or female, in childbearing age.
Key exclusion criteria (19 listed)
- - Patient which cannot receive FOLFOX 4 whatever the reason
- Patients < 18 years old and > 70 years old
- Malnourished patient (French National Authority for Health, 2003)
- Patients with all or part of an upper limb amputation
- Diabetic patient
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 |
|---|---|---|
| Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines | Behavioural | normal polyamines containing diet, polyamines depleted diet |
Primary outcome
Cold pain thresholds
Time frame: day 42
10 secondary outcomes
Cold pain thresholds
Time frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Heat pain thresholds
Time frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
DN4 (Douleur Neuropathique en 4 Questions) scores
Time frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
HADS (Hospital Anxiety and Depression Scale) score
Time frame: day -7, 0, 14, 28, 42, 98, 154
Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events))
Time frame: day 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Cancer response
Time frame: day 154
Oxaliplatin dose intensity
Time frame: day 154
Erythrocyte polyamine levels
Time frame: day -7, 0, 14, 28, 42, 70, 98
NPSI ( Neuropathic Pain Symptom Inventory)scores
Time frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
QLQ-C30 (Quality of Life questionnaire C30)scores
Time frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
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 11 Jul 2017.
- Derived from this study: PubMed 25833669Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.
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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.
Denis PEZET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines in people with Neuropathy and Digestive Cancer System, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 19 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 11 Jul 2017. 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 France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cold pain thresholds (time frame: day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775449, which also lists 1 linked publication.
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 11 Jul 2017.