Prostate CancerPhase 3MAPOCDNCT02928692
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium
A Phase 3 study testing Minocycline in people with Prostate Cancer and Carcinoma of the Rectum, run by RenJi Hospital at 5 sites in China.
Trial summary
Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Carcinoma of the Rectum, Colon Cancer
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 5 sitesChina
- Study dates
- Nov 2016to Dec 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elder than 65 years old
- Speak Chinese Mandarin
- Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
- Signed the inform consent
- American Society of Anesthesiologists classification I to III
- Elder than 65 years old
Show all 9Show fewer
- Speak Chinese Mandarin
- Signed the inform consent
- No major disease health people
Who cannot join
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
- Severe audition or vision disorder;
- Unwillingness to comply with the protocol or procedures.
- Cannot communicated with Chinese Mandarin
- With severe skin disease
Show all 19Show fewer
- Serious heart or liver or renal insufficiency patients
- Had surgery in the past 30 days
- Allergy to tetracycline or minocycline
- For the health volunteers;
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
- Severe audition or vision disorder;
- Unwillingness to comply with the protocol or procedures.
- Cannot communicated with Chinese Mandarin
- Drug abuse, alcoholism
- Serious heart or liver or renal insufficiency patients
- Had surgery in the past 30 days
- Plan to undergo surgery in the following 3 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Scales
Shanghai, Shanghai Municipality, 200127
Diansan Su, Dr., 18616514088, diansansu@yahoo.com
Hui Li, M.S., 15216711923, 56428923@qq.com
- Not yet recruiting
Shanghai Pudong Hospital
Shanghai
Hongwei Duan, 189-1879-0035
- Recruiting
Shanghai Pudong New Area Dongming Community Health Care Center
Shanghai
Shifen Zhang, 13916517543
- Recruiting
Shanghai Pudong New Area people's Hopsital
Shanghai
Lizhi Li, M.D., 139-1768-2738, Fmlilizhi@sina.com.cn
- Recruiting
Shanghai Tenth Hospital
Shanghai
Shukun Fu, M.D., 13816343916, shukunfu@163.com
About this study
Official title: Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium: A Multicenter, Randomized, Double-Blind Clinical Trail
Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients.
- Being tested
- Minocycline, Placebo
- Keywords
- Minocycline, Postoperative cognitive dysfunction, Postoperative delirium
- Medical subject headings
- Prostatic Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Carcinoma, Renal Cell, cyclopia sequence, Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered before surgery Receives: Drug: Placebo |
| Minocycline | Experimental | Minocycline was administrated before surgery Receives: Drug: Minocycline |
| Volunteers | No intervention | Health people for calculate the incidence of POCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
POCD incidence 7 days (or before leaving hospital) after surgery
Measured: 7 days (or before leaving hospital)
POD incidence
Measured: 1 to 5 days after surgery
Secondary outcomes (1)
POCD incidence 2 months after surgery
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Prostate 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Pudong New Area People's Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Aera Dongming Community Health Care Center
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928692
- Sponsor's protocol ID
- 20158202
- Acronym
- MAPOCD
- Status last verified
- Jan 2020
- First submitted
- 5 Oct 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
Publications
Large MC, Reichard C, Williams JT, Chang C, Prasad S, Leung Y, DuBeau C, Bales GT, Steinberg GD. Incidence, risk factors, and complications of postoperative delirium in elderly patients undergoing radical cystectomy. Urology. 2013 Jan;81(1):123-8. doi: 10.1016/j.urology.2012.07.086. Epub 2012 Nov 13.
PubMed 23153950Pol RA, van Leeuwen BL, Izaks GJ, Reijnen MM, Visser L, Tielliu IF, Zeebregts CJ. C-reactive protein predicts postoperative delirium following vascular surgery. Ann Vasc Surg. 2014 Nov;28(8):1923-30. doi: 10.1016/j.avsg.2014.07.004. Epub 2014 Jul 10.
PubMed 25017770Nadelson MR, Sanders RD, Avidan MS. Perioperative cognitive trajectory in adults. Br J Anaesth. 2014 Mar;112(3):440-51. doi: 10.1093/bja/aet420. Epub 2014 Jan 2.
PubMed 24384981Westhoff D, Witlox J, Koenderman L, Kalisvaart KJ, de Jonghe JF, van Stijn MF, Houdijk AP, Hoogland IC, Maclullich AM, van Westerloo DJ, van de Beek D, Eikelenboom P, van Gool WA. Preoperative cerebrospinal fluid cytokine levels and the risk of postoperative delirium in elderly hip fracture patients. J Neuroinflammation. 2013 Oct 7;10:122. doi: 10.1186/1742-2094-10-122.
PubMed 24093540Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.
PubMed 23040284van Meenen LC, van Meenen DM, de Rooij SE, ter Riet G. Risk prediction models for postoperative delirium: a systematic review and meta-analysis. J Am Geriatr Soc. 2014 Dec;62(12):2383-90. doi: 10.1111/jgs.13138.
PubMed 25516034American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
PubMed 25535170Bellelli G, Mazzola P, Morandi A, Bruni A, Carnevali L, Corsi M, Zatti G, Zambon A, Corrao G, Olofsson B, Gustafson Y, Annoni G. Duration of postoperative delirium is an independent predictor of 6-month mortality in older adults after hip fracture. J Am Geriatr Soc. 2014 Jul;62(7):1335-40. doi: 10.1111/jgs.12885. Epub 2014 Jun 2.
PubMed 24890941Ramaiah R, Lam AM. Postoperative cognitive dysfunction in the elderly. Anesthesiol Clin. 2009 Sep;27(3):485-96, table of contents. doi: 10.1016/j.anclin.2009.07.011.
PubMed 19825488Sauer AM, Kalkman C, van Dijk D. Postoperative cognitive decline. J Anesth. 2009;23(2):256-9. doi: 10.1007/s00540-009-0744-5. Epub 2009 May 15.
PubMed 19444566Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
PubMed 18156878Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
PubMed 19225398Vacas S, Degos V, Feng X, Maze M. The neuroinflammatory response of postoperative cognitive decline. Br Med Bull. 2013;106(1):161-78. doi: 10.1093/bmb/ldt006. Epub 2013 Apr 4.
PubMed 23558082Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.
PubMed 17325501
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium: A Multicenter, Randomized, Double-Blind Clinical Trail
- ClinicalTrials.gov ID
- NCT02928692
- Acronym / sponsor ID
- MAPOCD / 20158202
- Keywords
- Minocycline, Postoperative cognitive dysfunction, Postoperative delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Pudong New Area People's Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Aera Dongming Community Health Care Center
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Oct 2016 (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.
Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered before surgery |
| Minocycline | Experimental | Drug: MinocyclineMinocycline was administrated before surgery |
| Volunteers | No intervention | –Health people for calculate the incidence of POCD |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Elder than 65 years old
- Speak Chinese Mandarin
- Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
- Signed the inform consent
- American Society of Anesthesiologists classification I to III
Key exclusion criteria (19 listed)
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
- Severe audition or vision disorder;
- Unwillingness to comply with the protocol or procedures.
- Cannot communicated with Chinese Mandarin
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 |
|---|---|---|
| Minocycline | Drug | Minocycline |
| Placebo | Drug | Placebo |
Primary outcome
POCD incidence 7 days (or before leaving hospital) after surgery
Time frame: 7 days (or before leaving hospital)
POD incidence
Time frame: 1 to 5 days after surgery
1 secondary outcome
POCD incidence 2 months after surgery
Time frame: 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 23153950Large MC, Reichard C, Williams JT, Chang C, Prasad S, Leung Y, DuBeau C, Bales GT, Steinberg GD. Incidence, risk factors, and complications of postoperative delirium in elderly patients undergoing radical cystectomy. Urology. 2013 Jan;81(1):123-8. doi: 10.1016/j.urology.2012.07.086. Epub 2012 Nov 13.
- Background: PubMed 25017770Pol RA, van Leeuwen BL, Izaks GJ, Reijnen MM, Visser L, Tielliu IF, Zeebregts CJ. C-reactive protein predicts postoperative delirium following vascular surgery. Ann Vasc Surg. 2014 Nov;28(8):1923-30. doi: 10.1016/j.avsg.2014.07.004. Epub 2014 Jul 10.
- Background: PubMed 24384981Nadelson MR, Sanders RD, Avidan MS. Perioperative cognitive trajectory in adults. Br J Anaesth. 2014 Mar;112(3):440-51. doi: 10.1093/bja/aet420. Epub 2014 Jan 2.
- Background: PubMed 24093540Westhoff D, Witlox J, Koenderman L, Kalisvaart KJ, de Jonghe JF, van Stijn MF, Houdijk AP, Hoogland IC, Maclullich AM, van Westerloo DJ, van de Beek D, Eikelenboom P, van Gool WA. Preoperative cerebrospinal fluid cytokine levels and the risk of postoperative delirium in elderly hip fracture patients. J Neuroinflammation. 2013 Oct 7;10:122. doi: 10.1186/1742-2094-10-122.
- Background: PubMed 23040284Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.
- Background: PubMed 25516034van Meenen LC, van Meenen DM, de Rooij SE, ter Riet G. Risk prediction models for postoperative delirium: a systematic review and meta-analysis. J Am Geriatr Soc. 2014 Dec;62(12):2383-90. doi: 10.1111/jgs.13138.
- Background: PubMed 25535170American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
- Background: PubMed 24890941Bellelli G, Mazzola P, Morandi A, Bruni A, Carnevali L, Corsi M, Zatti G, Zambon A, Corrao G, Olofsson B, Gustafson Y, Annoni G. Duration of postoperative delirium is an independent predictor of 6-month mortality in older adults after hip fracture. J Am Geriatr Soc. 2014 Jul;62(7):1335-40. doi: 10.1111/jgs.12885. Epub 2014 Jun 2.
- Background: PubMed 19825488Ramaiah R, Lam AM. Postoperative cognitive dysfunction in the elderly. Anesthesiol Clin. 2009 Sep;27(3):485-96, table of contents. doi: 10.1016/j.anclin.2009.07.011.
- Background: PubMed 19444566Sauer AM, Kalkman C, van Dijk D. Postoperative cognitive decline. J Anesth. 2009;23(2):256-9. doi: 10.1007/s00540-009-0744-5. Epub 2009 May 15.
- Background: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
- Background: PubMed 18156878Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline in people with Prostate Cancer and Carcinoma of the Rectum, run by RenJi Hospital at 5 sites in China.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Doctor (18616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCD incidence 7 days (or before leaving hospital) after surgery (time frame: 7 days (or before leaving hospital)). 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?
On the ClinicalTrials.gov record for NCT02928692, which also lists 21 linked publications.
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 28 Jan 2020.