Anemia, Sickle CellPhase 1NCT00599482
Far Infrared Radiation for Sickle Cell Pain Management
A Phase 1 study testing Far Infrared Radiation (5μm to 20μm wavelength) in people with Anemia, Sickle Cell, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- Far Infrared Radiation (5μm to 20μm wavelength)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Jan 2009
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People with sickle cell disease
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis
Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation.
Read the detailed description
Painful sickle cell crises are treated with hydration and analgesics. Ischemia is an absolute or relative shortage of the blood supply to an organ. Relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue.
It is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. In addition, the analgesic properties of far infrared will alleviate pain due to the crisis.
- Conditions
- Anemia, Sickle Cell
- Being tested
- Far Infrared Radiation (5μm to 20μm wavelength)
- Keywords
- HEMOGLOBIN SC DISEASE, HEMOGLOBIN C DISEASE, SICKLE CELL TRAIT, THALASSEMIA
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobin SC Disease, Hemoglobin C Disease, Sickle Cell Trait, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Infrared Radiation (5μm to 20μm wavelength)Radiation
Far infrared radiation for 30 to 40 minutes during each session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Far Infrared Radiation Receives: Radiation: Far Infrared Radiation (5μm to 20μm wavelength) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Management
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Ken Nedd, M.D., Study chair, GAAD Medical Research Institute Inc.Kwasi Donyina, Ph.D., Study director, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599482
- Sponsor's protocol ID
- GAAD-SCC-CTP1
- Status last verified
- Jan 2009
- First submitted
- 11 Jan 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis
- ClinicalTrials.gov ID
- NCT00599482
- Acronym / sponsor ID
- GAAD-SCC-CTP1
- Conditions
- Anemia, Sickle Cell
- Keywords
- HEMOGLOBIN SC DISEASE, HEMOGLOBIN C DISEASE, SICKLE CELL TRAIT, THALASSEMIA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 23 Jan 2008 (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.
Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation.
Detailed description
Painful sickle cell crises are treated with hydration and analgesics. Ischemia is an absolute or relative shortage of the blood supply to an organ. Relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue.
It is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. In addition, the analgesic properties of far infrared will alleviate pain due to the crisis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)Far Infrared Radiation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People with sickle cell disease
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far Infrared Radiation (5μm to 20μm wavelength)Far infrared radiation for 30 to 40 minutes during each session. | Radiation | 1 |
Primary outcome
Pain Management
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
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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.
Ken Nedd, M.D. study chair
GAAD Medical Research Institute Inc.
Kwasi Donyina, Ph.D. study director
GAAD Medical Research Institute Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Far Infrared Radiation (5μm to 20μm wavelength) in people with Anemia, Sickle Cell, run by GAAD Medical Research Institute Inc. 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this 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 Management (time frame: 40 minutes). 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 5 Jan 2009.