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Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery

NCT04585620 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-09

No results posted yet for this study

Summary

Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.

Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date.

Study objectives:

Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A.

Methods:

Recruitment of test subjects:

Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.

Randomization and blinding:

Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial.

Data collection:

Data is collected by questionnaires delivered and answered by mail or digitally.

Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.

Conditions

  • Chronic Pain
  • Post-thoracotomy Pain Syndrome
  • Pain, Neuropathic
  • Pain, Postoperative

Interventions

DRUG

Onabotulinum Toxin A

Series of subcutaneous injections

DRUG

Normal saline

Series of subcutaneous injections

Sponsors & Collaborators

  • Allan Vestergaard Danielsen, MD

    lead OTHER

Principal Investigators

  • Allan V Danielsen, MD · Dept. of Cardiothoracic Surgery, Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-12-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585620 on ClinicalTrials.gov