ClinicalTrials.gg
Status unknownNCT02878447Updated Oct 26, 2017

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

An interventional study of External beam radiotherapy in Haemoptysis, sponsored by University of Stellenbosch. Status unknown at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University of Stellenbosch · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Currently the best curative treatment of massive haemoptysis is surgical resection of the affected portion of lung. For patients who do not qualify for surgery, there are few alternative interventions, most of which only provide a temporary solution.

Surgical resection of the diseased areas, which offers the possibility of cure, is best performed as an elective procedure. It carries a not insignificant mortality, with reports varying between 1% and 50%. Unfortunately, many patients admitted to Tygerberg Academic Hospital, are not candidates for either elective or emergency surgical resection. The most common reasons for inoperability are: irresectable disease (i.e. damage to the lungs is bilateral and too extensive to allow resection, or the site of bleeding is not known); or severely reduced cardiopulmonary reserves secondary to extensive pre-existing lung damage, making lung resection surgery impossible due to excessively high mortality risk.

Repeat BAE (as a palliative measure in inoperable cases) is not always technically feasible and does not always lead to cessation of the bleeding. Additionally long term recurrence rates following BAE are variable estimated at between 18-42%, and carries a high mortality.

A significant number of patients with massive haemoptysis do not qualify for either surgery or BAE, thus rendering them without treatment option, save palliation with long-term opiates. Their fate is that of recurrent haemoptysis and a high associated mortality. Endobronchial occluding devices have been considered, however their high cost and required expertise prohibits their extensive use.

A novel treatment of this condition potentially is external beam radiotherapy (EBRT). A case report of five patients has documented EBRT in the setting of mycetoma where between 7 and 14Gy was used, with cessation of life threatening haemoptysis. However follow-up was limited to 6 months, and the effects of EBRT in the setting of post-tuberculous structural lung disease without mycetoma is not known. The potential mechanism of the achieved haemostasis was speculated as being the induction of radiation damage to the radiosensitive capillaries, with subsequent inflammatory response, in keeping with previous rat models of lung perfusion following high dose (30Gy) EBRT exposure.

There is therefore a paucity of data on the utility of EBRT in benign conditions such bronchiectasis and aspergillomata. Furthermore due to the different effects, particularly temporal, the radiation has on normal and benign conditions it is difficult to extrapolate from the malignant scenario to the benign. Laboratory studies have however demonstrated the effects of high dose radiation on tissue that may result in a reduced bleeding tendency.

This study aims to explore a novel therapeutic strategy for patients with life-threatening haemoptysis who are not candidates for definitive management (i.e. lung resection). This study also aims to establish if there is a measurable response to varying doses of chest radiation in cases of haemoptysis caused by benign conditions.

This study is a prospective randomised control-intervention study. Patients will be allocated to one of 2 arms (control and EBRT at 3.5Gy weekly for 5 fractions to a maximum of 17G). The primary outcome will be time to recurrent haemoptysis. Secondary outcomes include physical performance, lung function and the occurrence of EBRT complications. Patients will be followed up daily whilst in hospital and for one year post intervention.

Assessors and those performing the statistical analysis will be blinded to the group allocation. Statistical analysis will include univariate and multivariate analysis with appropriate parametric or non-parametric tests. Appropriate tests for categorical data (e.g. Chi-squared test) and continuous data (e.g. Kruskal-Wallis, and ANOVA) will be used. Logistic and linear regression modelling will be used for certain outcomes, and multivariate analysis will be performed using step-wise regression modelling and full modelling where appropriate.

02

Conditions studied

  • Haemoptysis

Keywords

  • Haemoptysis
  • Radiotherapy
  • Tuberculosis
  • Aspergilloma
  • Bronchiectasis
03

In context

Hemoptysis

37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.

This study's planned enrollment of 40 is below the median of 73 across 20 interventional studies indexed under Hemoptysis.

Browse Hemoptysis studies →

Lead sponsor

University of Stellenbosch is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult subjects, 18 years of age and older.
  • Written 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    External Beam Radiotherapy

    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

  • No intervention
    Control

    Patients will receive best medical care.

Interventions

  • RadiationExternal beam radiotherapy

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Six minute walk test

    Improvement from baseline

    Time frame: 1 year

  2. Time to massive haemoptysis (>200mL per day)

    Time frame: 1 year

  3. Fev1/FVC

    Improvement from baseline

    Time frame: 1 year

  4. Total lung capacity (TLC) Total lung capacity (TLC)

    Improvement from baseline

    Time frame: 1 year

  5. Diffusion capacity (DLCO) Total lung capacity (TLC)

    Improvement from baseline

    Time frame: 1 year

  6. Radiological change in volume (maximum diameters in three planes)

    Performed by two radiologists to determine the radiological resolution of aspergillomata

    Time frame: 1 year

  7. Number of complications associated with Radiotherapy

    nausea, skin changes, pulmonary infection, pain etc.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University of Stellenbosch
    Cape Town, Western Cape 7602, South Africa
    Recruiting
08

References and documents

Publications

  • 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. PubMed 9711960 ↗
  • 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. PubMed 22054885 ↗
  • 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. Erratum In: Eur Respir J. 2009 Sep;34(3):782. PubMed 19567600 ↗
  • 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. PubMed 24334859 ↗
  • 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. PubMed 12109828 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2016, a primary completion of Mar 2018 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2016
First posted
Aug 25, 2016
Start
Jun 2016
Primary completionEst.
Mar 2018
CompletionEst.
Mar 2019
Last update
Oct 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02878447
Lead sponsor
University of Stellenbosch
Responsible party
Dr Brian Allwood (Principal investigator, University of Stellenbosch) — Principal investigator
First posted
Aug 25, 2016
Start date
Jun 2016
Primary completion
Mar 2018 (estimated)
Completion
Mar 2019 (estimated)
Last update
Oct 26, 2017

Study contacts

Brian Allwood, MBChB
Contact
brianallwood@sun.ac.za
Brian Allwood, MBChB, PhD
study chair · University of Stellenbosch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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