Breast CancerPhase 2PoLyDOLNCT00304850
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
A Phase 2 study testing polyamine-free diet in people with Breast Cancer and Surgery, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- polyamine-free diet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2006to May 2009
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer (T1, T2, T3, N0, N1, M0)
- Age : 18 - 75
- Asa 1-3
- left or right tumorectomy with complete lymphadenectomy
- left or right complete mastectomy with complete lymphadenectomy
- complete lymphadenectomy within one week following simple tumorectomy
- informed consent signed
Who cannot join
- inflammatory tumor requiring pre-operative radiotherapy
- previous history of total mastectomy or partial contralateral mastectomy
- chronic inflammatory disease treated by corticoids or NSAI
- chronic analgesic treatment
- anti-arrhythmic or anti-epileptic treatments
- morphinic treatment during the 7 days before surgery
Show all 9Show fewer
- excessive alcohol consumption or addiction
- ketamine or neomycin contra-indication
- severe cardiovascular disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne
Bordeaux, 33000
département d'anesthésie-réanimation 3, hôpital Pellegrin
Bordeaux, 33076
CLCC Alexis Vautrin
Nancy, 54511
APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation
Paris, 75013
CLCC Réné Huguenin de Saint Cloud
Saint-Cloud, 92210
About this study
Official title: Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine
Read the detailed description
This multicentric, single blind study will enrol 160 women (18-75 years old) operated on tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 = polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine + polyamine-free diet (n = 40).
The amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer). Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months using adequate questionnaire ( analgesic scale). Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood.
Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared (isobolographic method). Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery.
- Conditions
- Breast Cancer, Surgery
- Being tested
- polyamine-free diet, Ketamine or placebo
- Keywords
- polyamines, pain, breast cancer, mastectomy, post operative pain
- Medical subject headings
- Breast Neoplasms, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyamine-free dietBehavioural
Polyamine-free diet in the 7 days befor surgery
Ketamine or placeboDrug
Peroperative and post operative (48h) ketamine injection
| Study group | Role | What they receive |
|---|---|---|
| R+ / K+ | Experimental | Not described Receives: Behavioral: polyamine-free diet; Drug: Ketamine or placebo |
| R+ / K- | Experimental | Not described Receives: Behavioral: polyamine-free diet; Drug: Ketamine or placebo |
| R- / K+ | Experimental | Not described Receives: Drug: Ketamine or placebo |
| R- /K- | Placebo comparator | Not described Receives: Drug: Ketamine or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine requirement
Measured: for the 24 postoperative hours
Secondary outcomes (6)
Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery
Measured: 4 days
Allodynia measurements
Measured: inclusion, 1, 2, 4 and 7 ddays after surgery
Hyperesthesia measurements
Measured: inclusion, 1, 2, 4 and 7 ddays after surgery
Chronic pain incidence
Measured: 3 and 6 months
Late allodynia and/or hyperesthesia
Measured: 6 months
safety of treatment
Measured: Along each patient folow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Insurance CNP foundation
- Investigators
- Pierre MAURETTE, Pr, Principal investigator, DAR 3 -Pellegrin hospital-33076 Bordeaux - FranceGenevieve CHENE, Pr, Study chair, University hospital - 33076 Bordeaux - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304850
- Sponsor's protocol ID
- 9258-03
- Other IDs
- 2002-004
- Acronym
- PoLyDOL
- Status last verified
- Dec 2009
- First submitted
- 17 Mar 2006
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT00304850
- Acronym / sponsor ID
- PoLyDOL / 9258-03
- Conditions
- Breast Cancer, Surgery
- Keywords
- polyamines, pain, breast cancer, mastectomy, post operative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Insurance CNP foundation
- Study start
- Mar 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Mar 2006 (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.
After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine
Detailed description
This multicentric, single blind study will enrol 160 women (18-75 years old) operated on tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 = polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine + polyamine-free diet (n = 40).
The amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer). Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months using adequate questionnaire ( analgesic scale). Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood.
Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared (isobolographic method). Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| R+ / K+ | Experimental | Behavioral: polyamine-free diet, Drug: Ketamine or placebo |
| R+ / K- | Experimental | Behavioral: polyamine-free diet, Drug: Ketamine or placebo |
| R- / K+ | Experimental | Drug: Ketamine or placebo |
| R- /K- | Placebo comparator | Drug: Ketamine or placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Breast cancer (T1, T2, T3, N0, N1, M0)
- Age : 18 - 75
- Asa 1-3
- left or right tumorectomy with complete lymphadenectomy
- left or right complete mastectomy with complete lymphadenectomy
Key exclusion criteria (9 listed)
- inflammatory tumor requiring pre-operative radiotherapy
- previous history of total mastectomy or partial contralateral mastectomy
- chronic inflammatory disease treated by corticoids or NSAI
- chronic analgesic treatment
- anti-arrhythmic or anti-epileptic treatments
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 |
|---|---|---|
| polyamine-free dietPolyamine-free diet in the 7 days befor surgery | Behavioural | R+ / K+, R+ / K- |
| Ketamine or placeboPeroperative and post operative (48h) ketamine injection | Drug | R+ / K+, R+ / K-, R- / K+, R- /K- |
Primary outcome
Morphine requirement
Time frame: for the 24 postoperative hours
6 secondary outcomes
Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery
Time frame: 4 days
Allodynia measurements
Time frame: inclusion, 1, 2, 4 and 7 ddays after surgery
Hyperesthesia measurements
Time frame: inclusion, 1, 2, 4 and 7 ddays after surgery
Chronic pain incidence
Time frame: 3 and 6 months
Late allodynia and/or hyperesthesia
Time frame: 6 months
safety of treatment
Time frame: Along each patient folow-up
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 29 Dec 2009.
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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.
Pierre MAURETTE, Pr principal investigator
DAR 3 -Pellegrin hospital-33076 Bordeaux - France
Genevieve CHENE, Pr study chair
University hospital - 33076 Bordeaux - France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing polyamine-free diet in people with Breast Cancer and Surgery, run by University Hospital, Bordeaux at 5 sites 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 7 inclusion and 9 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 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Morphine requirement (time frame: for the 24 postoperative hours). 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 29 Dec 2009.