The Utility of Radiotherapy in the Management of Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases

NCT02878447 | Unknown

• 1 other identifier: M15/09/033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The sequelae of tuberculosis are still the commonest causes of haemoptysis in the developing world, where life-threatening haemoptysis remains a common and not infrequently fatal medical emergency. Haemoptysis can be life-threatening either as a result of compromised gas exchange or because of circulatory collapse secondary to acute blood loss. Haemodynamic and ventilatory support, followed by bronchial artery embolisation (BAE) as a bridge to potentially curative treatment such as lung resection, remains the standard of care. Often patients do not qualify for surgical intervention and BAE is, at best, a temporary solution. External beam radiotherapy (EBRT) may be an alternative, curative intervention in the management of haemoptysis in patients with no alternative options. There is a paucity of studies reporting the use of EBRT in patients without malignancy and with regards to specific doses of EBRT. This pilot study aims to explore the potential of varying doses of EBRT in the management of massive haemoptysis.

Conditions

Haemoptysis

Keywords

Haemoptysis; Radiotherapy; Tuberculosis; Aspergilloma; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Composite end-point of time to recurrent life-threatening haemoptysis, or death

  1 year

Secondary Outcomes (7)

• Six minute walk test

  1 year

• Time to massive haemoptysis (>200mL per day)

  1 year

• Fev1/FVC

  1 year

• Total lung capacity (TLC) Total lung capacity (TLC)

  1 year

• Diffusion capacity (DLCO) Total lung capacity (TLC)

  1 year

Study Arms (2)

External Beam Radiotherapy

EXPERIMENTAL

Patients will receive radiotherapy (3.5Gy weekly for 5 fractions to a maximum of 17G) prescribed to a central plane using mega-voltage radiation encompassing all the assessed affected lung tissue

Radiation: External beam radiotherapy

Control

NO INTERVENTION

Patients will receive best medical care.

Interventions

External beam radiotherapy RADIATION

External beam radiotherapy will be prescribed to a central plane using mega-voltage radiation encompassing all the assessed affected lung tissue at 3.5Gy weekly for 5 fractions to a maximum of 17G

External Beam Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Adult subjects, 18 years of age and older.
• Written informed consent provided by patient
• Current or previously documented admission to hospital with large volume haemoptysis (\>200ml); or haemoptysis with haemodynamic compromise (SBP \< 100mmHg for 15 minutes) or requiring fluid resuscitation; haemoptysis requiring intubation or deemed life-threatening by attending clinicians.
• The cause of haemoptysis must be due to severe underlying lung destruction/ bronchiectasis, post-tuberculous lung damage or the presence of an aspergillomata.
• Primary bronchial artery embolisation not considered technically possible or failed BAE
• Lung resection not possible because of poor cardiopulmonary reserves (as defined by the current ERS/ESTS clinical guidelines, independently reviewed by a team of consisting of a thoracic surgeon, pulmonologist and anaesthetist who will need to be in agreement on inoperability and/or lack of cardiopulmonary reserve)

You may not qualify if:

• Active tuberculosis
• High clinical suspicion of lung carcinoma
• Known deep venous thrombosis or pulmonary embolism
• Any social or psychological condition that may impair insight or compliance with the study including follow up
• Any other condition, which in the opinion of the investigators, places the subject at increased risk for transport and administration of EBRT e.g. severe haemodynamic instability, mechanical ventilation with high FiO2 requirements etc.

Sponsors & Collaborators

• University of Stellenbosch: lead

Study Sites (1)

University of Stellenbosch

Cape Town, Western Cape, 7602, South Africa

RECRUITING

Related Publications (5)

• Fernando HC, Stein M, Benfield JR, Link DP. Role of bronchial artery embolization in the management of hemoptysis. Arch Surg. 1998 Aug;133(8):862-6. doi: 10.1001/archsurg.133.8.862.

  PMID: 9711960 BACKGROUND

• von Groote-Bidlingmaier F, Koegelenberg CF, Bolliger CT. Functional evaluation before lung resection. Clin Chest Med. 2011 Dec;32(4):773-82. doi: 10.1016/j.ccm.2011.08.001.

  PMID: 22054885 BACKGROUND

• Brunelli A, Charloux A, Bolliger CT, Rocco G, Sculier JP, Varela G, Licker M, Ferguson MK, Faivre-Finn C, Huber RM, Clini EM, Win T, De Ruysscher D, Goldman L; European Respiratory Society and European Society of Thoracic Surgeons joint task force on fitness for radical therapy. ERS/ESTS clinical guidelines on fitness for radical therapy in lung cancer patients (surgery and chemo-radiotherapy). Eur Respir J. 2009 Jul;34(1):17-41. doi: 10.1183/09031936.00184308.

  PMID: 19567600 BACKGROUND

• Koegelenberg CF, Bruwer JW, Bolliger CT. Endobronchial valves in the management of recurrent haemoptysis. Respiration. 2014;87(1):84-8. doi: 10.1159/000355198. Epub 2013 Dec 4.

  PMID: 24334859 BACKGROUND

• Falkson C, Sur R, Pacella J. External beam radiotherapy: a treatment option for massive haemoptysis caused by mycetoma. Clin Oncol (R Coll Radiol). 2002 Jun;14(3):233-5. doi: 10.1053/clon.2002.0063.

  PMID: 12109828 BACKGROUND

MeSH Terms

Conditions

Hemoptysis; Tuberculosis; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bronchial Diseases

Study Officials

• Brian Allwood, MBChB, PhD

  University of Stellenbosch

  STUDY CHAIR

Central Study Contacts

Brian Allwood, MBChB

CONTACT

brianallwood@sun.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: August 25, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)