Cordotomy in Reducing Pain in Patients With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

NCT05077072

Head and Neck Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain

NCT04296305

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

ACTIVE_NOT_RECRUITING PHASE4

Morphine for the Treatment of Pain in Patients With Breast Cancer

NCT00003000

Pain

COMPLETED

Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

NCT02459964

Advanced Cancers Pain

COMPLETED PHASE4

Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent for Cancer Pain

NCT00101621

Cancer Pain

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain.

SECONDARY OBJECTIVES:

I. Define the patient experience of cordotomy for cancer pain refractory to palliative care.

II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a cordotomy over 1-2 hours.

GROUP II: Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.

After completion of study, patients are followed up at 2 weeks and once every month for up to 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I (cordotomy)

Patients undergo a cordotomy over 1-2 hours.

Group Type EXPERIMENTAL

Cordotomy

Intervention Type PROCEDURE

Undergo cordotomy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (morphine, fake cordotomy)

Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.

Group Type SHAM_COMPARATOR

Morphine

Intervention Type DRUG

Given via injection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Sham Intervention

Intervention Type PROCEDURE

Undergo fake cordotomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cordotomy

Undergo cordotomy

Intervention Type PROCEDURE

Morphine

Given via injection

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Sham Intervention

Undergo fake cordotomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ability to provide informed consent
* Has undergone 3 palliative care evaluations
* Pain intensity \>= 4 on a 0-10 numerical scale
* Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)

Exclusion Criteria

* Uncorrectable coagulopathy
* Large intracranial mass
* Inability to complete assessment forms
* Life expectancy \< 1 month
* Contraindication to intravenous sedation
* Morphine allergy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No