Late Radiation InjuryNCT02425215
HBOT Late Radiation Tissue Injury
An observational study of Late Radiation Injury and Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: Radiotherapy is a common treatment for many malignancies. Radiation-related complications developing months or years after radiation treatment are known as late radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors who have received radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Late Radiation Injury, Chronic Pain
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing hyperbaric oxygen therapy for delayed radiation tissue injury in the Hyperbaric Unit.
Who may be able to join
- Patients who had radiation therapy, developed late radiation tissue injury and are eligible for hyperbaric oxygen therapy.
- Pain ≥ 5 in any anatomic site with duration > 3 months
Who cannot join
- Patient refusal
- Patient inability to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Hyperbaric Oxygen Therapy (HBOT) Reduce Pain, Improve Depression and Impact on Patients' Quality of Life for Those Suffering From Late Radiation Tissue Injury?
Background: Radiotherapy is a common treatment for many malignancies. Radiation-related complications developing months or years after radiation treatment are known as late radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors who have received radiation.
Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases of refractory pain in oncological patients with radiation soft tissue injury. Other studies showed significant improvement in pain intensity in patients with breast cancer and pelvic malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in lymphoedema. A prospective case study of 16 patients with gynecological cancer found no changes with respect to pain and depression outcomes. A trial in patients with radiation induced proctopathy showed that 75% of patients with rectal pain had some improvement, although none experienced a complete resolution of pain symptoms.
Read more
There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all demonstrated a modification in the pain response following HBOT. In animal studies HBOT decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in non-injured tissues.
In human studies, HBOT decreased pain and edema and improved function in patients suffering from the complex regional pain syndrome, and improved pain scores and range of motion in patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in symptoms and these effects were lasting for 6 months following treatment. HBOT was also found to be an effective treatment for cluster headaches and migraines and alleviated muscle and bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related osteonecrosis of the jaw.
Based on the evidence presented above and HBOT's known analgesic effect in many conditions, the investigators designed this study with the objective to evaluate if HBOT reduces pain, improves depression and impacts on patients quality of life in patients suffering from late radiation tissue injury.
Study Design: Prospective observational study (n=300). Patients that have had radiation therapy for malignancy, developed late radiation injury and suffer from chronic pain.
- Conditions
- Late Radiation Injury, Chronic Pain
- Keywords
- Hyperbaric Oxygen Treatment, Late radiation injury, Adult, Malignancy, Quality of Life, Chronic Pain
- Medical subject headings
- Chronic Pain, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (11 point numeric rating scale, Brief Pain Inventory short form )
Pain will be assessed with the 11 point numeric rating scale (NRS; 0 = "no pain" to 10 = "unbearable pain").Patients will be asked to document their pain during the previous 24 hours daily upon awakening and immediately after the intervention. Daily and weekly mean pain scores and the proportion of responders, defined as patients with a ≥30% reduction in mean pain score from baseline to endpoint will be recorded.
The Brief Pain Inventory short form will also be administered.
Measured: 6 months post-treatment
Secondary outcomes (5)
Pain Disability (pain disability index)
Will be measured using the pain disability index (PDI). The tool is valid and reliable instrument widely used to assess chronic pain patients in research and clinical settings.
Measured: 6 months post-treatment
Quality of Life Measurement (EORTC QLQ C30)
Will be assessed with the European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ C30). The EORTC QLQ-C30 is a self administered questionnaire developed to assess the quality of life of cancer patients. It has been translated and validated into 81 languages and is used in more than 3,000 studies worldwide. It is composed of both multi-item scales and single item measures.These include 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties).
Measured: 6 months post-treatment
The Patient Global Impression of Change
The scale has been recommended by Initiatives on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to evaluate the efficacy of treatment in chronic pain trials. It assesses global response to treatment and uses a 7-point Likert scale that varies from 1 (very much improved) to 7 (very much worse).
Measured: 6 months post-treatment
Depression and Anxiety (Hospital Anxiety (HADS-A) and Depression (HADS-D) scale)
Depression and anxiety will be assessed with the Hospital Anxiety (HADS-A) and Depression (HADS-D) scale, consisting of 14 items (7 each for anxiety and depression).
Measured: 6 months post-treatment
Pain medications
Change of pain medications.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: Lack of resources to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Radiation InjuryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Katznelson, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425215
- Sponsor's protocol ID
- 14-7413
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2015
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hyperbaric Oxygen Therapy (HBOT) Reduce Pain, Improve Depression and Impact on Patients' Quality of Life for Those Suffering From Late Radiation Tissue Injury?
- ClinicalTrials.gov ID
- NCT02425215
- Acronym / sponsor ID
- 14-7413
- Conditions
- Late Radiation Injury, Chronic Pain
- Keywords
- Hyperbaric Oxygen Treatment, Late radiation injury, Adult, Malignancy, Quality of Life, Chronic Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of resources to complete the study
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Radiotherapy is a common treatment for many malignancies. Radiation-related complications developing months or years after radiation treatment are known as late radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors who have received radiation.
Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases of refractory pain in oncological patients with radiation soft tissue injury. Other studies showed significant improvement in pain intensity in patients with breast cancer and pelvic malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in lymphoedema. A prospective case study of 16 patients with gynecological cancer found no changes with respect to pain and depression outcomes. A trial in patients with radiation induced proctopathy showed that 75% of patients with rectal pain had some improvement, although none experienced a complete resolution of pain symptoms.
There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all demonstrated a modification in the pain response following HBOT. In animal studies HBOT decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in non-injured tissues.
In human studies, HBOT decreased pain and edema and improved function in patients suffering from the complex regional pain syndrome, and improved pain scores and range of motion in patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in symptoms and these effects were lasting for 6 months following treatment. HBOT was also found to be an effective treatment for cluster headaches and migraines and alleviated muscle and bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related osteonecrosis of the jaw.
Based on the evidence presented above and HBOT's known analgesic effect in many conditions, the investigators designed this study with the objective to evaluate if HBOT reduces pain, improves depression and impacts on patients quality of life in patients suffering from late radiation tissue injury.
Study Design: Prospective observational study (n=300). Patients that have had radiation therapy for malignancy, developed late radiation injury and suffer from chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing hyperbaric oxygen therapy for delayed radiation tissue injury in the Hyperbaric Unit.
Key inclusion criteria (2 listed)
- Patients who had radiation therapy, developed late radiation tissue injury and are eligible for hyperbaric oxygen therapy.
- Pain ≥ 5 in any anatomic site with duration > 3 months
Key exclusion criteria (2 listed)
- Patient refusal
- Patient inability to answer the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity (11 point numeric rating scale, Brief Pain Inventory short form )
Time frame: 6 months post-treatment
Pain will be assessed with the 11 point numeric rating scale (NRS; 0 = "no pain" to 10 = "unbearable pain").Patients will be asked to document their pain during the previous 24 hours daily upon awakening and immediately after the intervention. Daily and weekly mean pain scores and the proportion of responders, defined as patients with a ≥30% reduction in mean pain score from baseline to endpoint will be recorded. The Brief Pain Inventory short form will also be administered.
5 secondary outcomes
Pain Disability (pain disability index)
Time frame: 6 months post-treatment
Quality of Life Measurement (EORTC QLQ C30)
Time frame: 6 months post-treatment
The Patient Global Impression of Change
Time frame: 6 months post-treatment
Depression and Anxiety (Hospital Anxiety (HADS-A) and Depression (HADS-D) scale)
Time frame: 6 months post-treatment
Pain medications
Time frame: 6 months post-treatment
Results and safety
The study was stopped early (reason given: Lack of resources to complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Katznelson, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Radiation Injury and Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources to complete the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (11 point numeric rating scale, Brief Pain Inventory short form ) (time frame: 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.