DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Breast Surgery

Neuropathic Pain After Breast Surgery



Sponsors


Source

Danish Pain Research Center

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging
from molecular pathways to societal impacts.

Detailed Description

Pain and loss of function are intimately associated with the reaction of the nervous system
to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma,
metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to
neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively
impact the individual's quality of life; moreover, the condition leads to significant costs
to the healthcare system and society. Not all subjects with such a lesion develop neuropathic
pain, and those who do develop neuropathic pain have varying degrees of symptom severity,
impact and outcomes and may respond unpredictably to treatment.

The interaction between genetics and environmental and clinical factors in a susceptible
individual most likely contribute to the variation in pain prevalence and severity. A better
understanding of the exact nature of these risk factors and their interactions will
ultimately improve the patients' health, both in terms of recognizing patients at risk and
identifying new treatment modalities.

Genetic, neurophysiological and psychological factors all influence the risk of developing
persistent pain. It is therefore possible to describe a genetic, neurophysiological and
psychological profile, in particular in patients experiencing neuropathic pain after surgery
and/or neurotoxic chemotherapy.

Overall Status

Recruiting

Start Date

2017-08-15

Completion Date

2019-11-01

Primary Completion Date

2019-11-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Chronic neuropathic pain, postoperative
12 months after surgery

Secondary Outcome

Measure

Time Frame

Chronic chemotherapy-induced peripheral neuropathy
12 months after surgery
Chronic chemotherapy-induced neuropathic pain
12 months after surgery

Number Of Groups

1

Enrollment

275

Conditions


Intervention

Intervention Type

Procedure

Intervention Name


Description

Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.


Eligibility

Study Pop

Patients scheduled for breast cancer resection at the Department of Breast Surgery, Aarhus
University Hospital, Aarhus, Denmark.

Sampling Method

Probability Sample

Criteria

Inclusion Criteria:

- Patients scheduled for breast cancer resection performed via lumpectomy (partial or
segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and
axillary lymph node dissection, and any combinations hereof.

- Willingness and ability to comply with study procedures as judged by the site
investigator/manager.

- Expected availability for follow-up throughout the study, i.e., ~12 months.

- Willingness to voluntarily sign and date the study-specific informed consent form.

Exclusion Criteria:

- Mental incapacity or language barriers precluding adequate understanding of study
procedures.

- Current alcohol or substance abuse according to the site investigator's medical
judgement.

- Unsuitability for participation in the study for any other reason, e.g. due to a
significant serious underlying condition (e.g. other cancer or AIDS), as determined by
the site investigator/manager.

Gender

Female

Minimum Age

18 Years

Maximum Age

80 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Nanna B Finnerup, DMSc
Study Director
Danish Pain Research Center, Aarhus University

Overall Contact

Last Name

Kasper Grosen, PhD

Phone

+45 78463287

Email



Location

Facility

Status

Contact

Investigator

Danish Pain Research Center, Aarhus University Hospital
Aarhus C 8000 Denmark
Recruiting
Last Name: Kasper Grosen, PhD
Phone: +45 78463287
Email: [email protected]
Last Name: Kasper Grosen, PhD
Role: Principal Investigator

Last Name: Nanna B Finnerup, DMSc
Role: Sub-Investigator

Last Name: Lone Nikolajsen, DMSc
Role: Sub-Investigator

Last Name: Kristine J Bennedsgaard, MD
Role: Sub-Investigator

Last Name: Lise Ventzel, PhD
Role: Sub-Investigator

Last Name: Hanne Rønning, MD
Role: Sub-Investigator

Last Name: Inge S Andersen, MD PhD
Role: Sub-Investigator

Department of Breast Surgery, Aarhus University Hospital
Aarhus 8200 Denmark
Not yet recruiting
Last Name: Hanne Rønning, MD
Phone: +45 78465105
Email: [email protected]
Breast Surgery Clinic, Viborg Regional Hospital
Viborg 8800 Denmark
Recruiting
Last Name: Inge S Andersen, MD PhD
Phone: +45 7844 6360
Email: [email protected]

Location Countries

Country

Denmark


Verification Date

2017-10-01

Lastchanged Date

2017-10-05

Firstreceived Date

2017-04-19

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Nanna B Finnerup, DMSc

Phone

+45 78464230

Email



Biospec Retention

Samples With DNA

Biospec Descr

Blood

Reference

Citation

Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725.

PMID

20876709


Citation

Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DL, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice AS, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-606. doi: 10.1097/j.pain.0000000000000492. Review.

PMID

27115670



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

April 19, 2017

Study First Submitted Qc

April 19, 2017

Study First Posted

April 21, 2017

Last Update Submitted

October 5, 2017

Last Update Submitted Qc

October 5, 2017

Last Update Posted

October 6, 2017


ClinicalTrials.gov processed this data on October 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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