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

NCT04585620 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 74719
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Botulinum toxin; Onabotulinum toxin A

Outcome Measures

Primary Outcomes (2)

• Rate of recruitment

  Recruitment of 30 test subjects within twelve months.

  12 months

• Incidence of treatment procedure disruption

  Proportion of test subjects terminating the treatment procedure after randomization by request due to unacceptable pain or discomfort during the procedure.

  12 months

Secondary Outcomes (6)

• Neuropathic Pain Symptoms Inventory (NPSI)

  Baseline, 1 and 3 moths after treatment

• Activities of daily life

  Baseline, 1 and 3 months

• Patient's Global Impression of Change (PGIC)

  1 and 3 months after treatment.

• Pain at rest, coughing and when active

  Weekly after treatment for three months

• General Health

  Baseline, 1 and 3 months after treatment

Other Outcomes (1)

• Incidence of treatment procedure disruption for the first half of test subjects

  Through study inclusion period of 12 months

Study Arms (2)

BTX-A

ACTIVE COMPARATOR

Onabotulinum toxin A is reconstructed with 4 ml of normal saline in a vial containing 100 U (Allergen Units). At a single treatment session, test subjects receive a series of subcutaneous injections with 2,5 U Onabotulinum toxin A equivalent to 0,1 ml of solution after reconstruction. One injection is given per 1 square centimeter in the painful area in relation to the scar on the chest wall. The maximum number of subcutaneous injections is 40, equivalent to a maximum dose of 100 U of Onabotulinum toxin in a total volume of 4 ml solution. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.

Drug: Onabotulinum Toxin A

Placebo

PLACEBO COMPARATOR

At a single treatment session, test subjects receive a series of subcutaneous injections with one injection per 1 square centimeter in the painful area in relation to the scar on the chest wall with an inert solution, i.e. 0.1 ml injections of normal saline up to a total volume of 4 ml, depending on the area of the painful area. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.

Drug: Normal saline

Interventions

Onabotulinum Toxin A DRUG

Series of subcutaneous injections

Also known as: BTX-A

BTX-A

Normal saline DRUG

Series of subcutaneous injections

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 18 years of age or above.
• Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.
• Patients who are radically treated for pulmonary malignancy
• Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.

You may not qualify if:

• Patients who cannot understand oral and written information.
• Patients who were not radically operated.
• Patients with other concomitant or other active cancer diseases.
• Patients with chronic pain in the chest wall prior to surgery.
• Pregnant women or women planning to get pregnant in the study period.
• Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy.
• Patients with intolerance or allergy to BOTOX®.
• Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.

Sponsors & Collaborators

• Allan Vestergaard Danielsen, MD: lead

Study Sites (1)

Dept. of Cardiothoracic Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Pain, Postoperative

Interventions

onabotulinum toxin A; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Allan V Danielsen, MD

  Dept. of Cardiothoracic Surgery, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan V Danielsen, MD

CONTACT

+45 29720229; a.danielsen@rn.dk

Jan J Andreasen, MD PhD

CONTACT

+45 9766 4651; jja@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: October 14, 2020
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)