Breast CancerPhase 1/2DIGNITYNCT00826085
Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall
A Phase 1/2 study testing ThermoDox in combination with Microwave Hyperthermia (heat) in people with Breast Cancer, run by Imunon at 6 sites in United States.
Trial summary
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ThermoDox in combination with Microwave Hyperthermia (heat)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2013to Jun 2016
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):
- Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible.
- Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
- Breast carcinoma for medical reasons not being resected
- Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
- Disease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:
Show all 13Show fewer
- One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
- Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
- Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:
- They have received standard anti-tumor treatment for their brain metastases without encephalopathy;
- Their neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.
- Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
- Provide written informed consent and willing to comply with protocol requirements.
Who cannot join
- Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
- Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
- Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received):
- Free (i.e., non-liposomal) or liposomal doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.
- Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
- Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):
Show all 26Show fewer
- ANC Granulocytes < 1,500/ microliter
- Platelets < 75,000/ microliter
- Hemoglobin < 9 gm/dL
- Total Bilirubin > 2 mg/dL
- ALT and AST > 2.5 X upper limit of normal
- Creatinine > 1.5 X upper limit of normal.
- ECOG/Zubrod Performance Status > 2.
- MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
- Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
- History of:
- Acute coronary syndrome
- Cerebral vascular accident
- Abnormal cardiac stress testing within last 6 months
- Symptomatic coronary artery disease
- Uncontrolled hypertension or cardiomyopathy
- Cardiac valvular surgery or open heart surgery
- Known structural heart disease.
- Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
- Active infection requiring antibiotic treatment
- Has received any external radiation therapy within 28 days prior to enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland, 21201
Southeastern Regional Medical Center
Newnan, Georgia, 30265
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
University of California, San Francisco
San Francisco, California, 94143
Washington University in St. Louis
St Louis, Missouri, 63110
Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
About this study
Official title: A Phase I/II Study Evaluating the Maximum Tolerated Dose, Bioequivalence/Pharmacokinetics, Safety, and Efficacy of Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Local-Regional Recurrent Breast Cancer.
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.
Read the detailed description
Breast cancer is the most common malignancy in women in both the United States and the world. Despite a variety of hormonal, cytotoxic and biologic approaches, a significant number of tumors will recur in the chest wall and axillary area following primary treatment. Any local recurrence of breast cancer after mastectomy is generally regarded as a poor prognostic indicator. However, it is also generally agreed that those who present without measurable metastatic disease at the time of loco-regional recurrence (LRR) have a more favorable disease and may experience long-term survival. Overall up to 35% of women with operable breast cancer will experience an isolated LRR following their primary treatment. Patients with LRR suffer from disfiguring tumors and other clinical signs and symptoms including pain, lymphedema limiting range of motion in the affected extremity, foul-smelling wounds, and a visual reminder of tumor progression. Up to 40% of patients undergoing a mastectomy as their primary treatment will experience a recurrence at the chest wall or overlying skin (RCW).
For initial curative intent in LRR, available interventions include surgical resection in patients whose tumor and clinical status permits anesthesia and surgical removal, radiation therapy in patients whose tumor and clinical status permits additional radiation, systemic hormonal and/or cytotoxic chemotherapy in patients whose tumors are sensitive to such drugs and combinations of the aforementioned. For unresectable LRR tumors, radiation and chemotherapy are used to manage the disease. In this setting some success has been achieved; however, a patient who reoccurs following these treatments is often treated with palliative intent.
Diathermy refers to the therapeutic generation of local heat in body tissues by high-frequency electromagnetic radiation, electric currents, or ultrasonic waves. In mild hyperthermia local tissue temperatures are restricted to a range of 39-45°C. Two types of external devices, microwave systems and ultrasound systems, have been approved by the FDA for delivering mild hyperthermia to the chest wall.
Mild hyperthermia from either microwave or ultrasound devices has been used safely in breast cancer treatment. In conjunction with external beam radiation, both types of devices have been used to heat the chest wall and both devices have demonstrated enhanced effects when compared to radiation therapy without additional hyperthermia.
Doxorubicin hydrochloride is a cytotoxic anthracycline antibiotic. The recommended single-agent dose of doxorubicin HCl (Adriamycin®) for injection is 60 to 75 mg/m2 intravenously (IV) in three-week cycles. Acute myelosuppression and long term, cumulative, cardiotoxicity (congestive heart failure) are dose-limiting. Doxorubicin is active against breast cancer as a single agent and is used with other drugs in multi-agent chemotherapy regimens. In LRR breast cancer, single agent doxorubicin achieves response rates comparable to combination chemotherapy.
Lyso-thermosensitive liposomal doxorubicin (ThermoDox®) is a temperature sensitive liposomal drug delivery system that selectively accumulates in tumors as a result of their leaky vasculature. During ThermoDox/hyperthermia therapy, the tumor is heated locally while the rest of the body remains at a normal temperature. When the liposomes encounter a temperature of 39.5°C or above, they release doxorubicin locally into the heated area. Liposomal doxorubicin is administered intravenously and, because it is particulate, will eventually be removed from circulation by the reticuloendothelial system in the liver and spleen. Pharmacokinetic data from liver cancer patients treated with radiofrequency ablation (RFA) and ThermoDox show that the major portion of exposure to ThermoDox (about 95% of the liposomal doxorubicin plasma AUC0-∞) occurs during the first six hours following the infusion, establishing this time period as optimal for application of hyperthermia. Animal studies have repeatedly shown higher tumor doxorubicin concentrations and enhanced tumor cell killing when ThermoDox is combined with hyperthermia compared to doxorubicin without hyperthermia.
- Conditions
- Breast Cancer
- Being tested
- ThermoDox in combination with Microwave Hyperthermia (heat)
- Keywords
- Breast Cancer, Recurrent Chest Wall Cancer, Loco-regional Recurrent Breast Cancer, Breast Cancer Recurrence at the Chest Wall
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoDox in combination with Microwave Hyperthermia (heat)Drug
ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion.
Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system.
All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| Thermodox in combination with hyperthermia | Experimental | Single arm study Receives: Drug: ThermoDox in combination with Microwave Hyperthermia (heat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer.
Measured: PK collection at Cycle 1 and Cycle 2
To determine efficacy of ThermoDox in combination with Hyperthermia
Measured: Efficacy assessed at Cycle 3, Cycle 5 and End of Treatment
Secondary outcomes (1)
To evaluate the safety of ThermoDox in combination with Hyperthermia
Measured: Through 6 treatment Cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Borys, MD, Study director, Imunon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826085
- Sponsor's protocol ID
- 105-08-201
- Acronym
- DIGNITY
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2009
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zagar TM, Vujaskovic Z, Formenti S, Rugo H, Muggia F, O'Connor B, Myerson R, Stauffer P, Hsu IC, Diederich C, Straube W, Boss MK, Boico A, Craciunescu O, Maccarini P, Needham D, Borys N, Blackwell KL, Dewhirst MW. Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer. Int J Hyperthermia. 2014 Aug;30(5):285-94. doi: 10.3109/02656736.2014.936049.
PubMed 25144817
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Evaluating the Maximum Tolerated Dose, Bioequivalence/Pharmacokinetics, Safety, and Efficacy of Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Local-Regional Recurrent Breast Cancer.
- ClinicalTrials.gov ID
- NCT00826085
- Acronym / sponsor ID
- DIGNITY / 105-08-201
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Recurrent Chest Wall Cancer, Loco-regional Recurrent Breast Cancer, Breast Cancer Recurrence at the Chest Wall
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Jan 2009 (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.
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.
Detailed description
Breast cancer is the most common malignancy in women in both the United States and the world. Despite a variety of hormonal, cytotoxic and biologic approaches, a significant number of tumors will recur in the chest wall and axillary area following primary treatment. Any local recurrence of breast cancer after mastectomy is generally regarded as a poor prognostic indicator. However, it is also generally agreed that those who present without measurable metastatic disease at the time of loco-regional recurrence (LRR) have a more favorable disease and may experience long-term survival. Overall up to 35% of women with operable breast cancer will experience an isolated LRR following their primary treatment. Patients with LRR suffer from disfiguring tumors and other clinical signs and symptoms including pain, lymphedema limiting range of motion in the affected extremity, foul-smelling wounds, and a visual reminder of tumor progression. Up to 40% of patients undergoing a mastectomy as their primary treatment will experience a recurrence at the chest wall or overlying skin (RCW).
For initial curative intent in LRR, available interventions include surgical resection in patients whose tumor and clinical status permits anesthesia and surgical removal, radiation therapy in patients whose tumor and clinical status permits additional radiation, systemic hormonal and/or cytotoxic chemotherapy in patients whose tumors are sensitive to such drugs and combinations of the aforementioned. For unresectable LRR tumors, radiation and chemotherapy are used to manage the disease. In this setting some success has been achieved; however, a patient who reoccurs following these treatments is often treated with palliative intent.
Diathermy refers to the therapeutic generation of local heat in body tissues by high-frequency electromagnetic radiation, electric currents, or ultrasonic waves. In mild hyperthermia local tissue temperatures are restricted to a range of 39-45°C. Two types of external devices, microwave systems and ultrasound systems, have been approved by the FDA for delivering mild hyperthermia to the chest wall.
Mild hyperthermia from either microwave or ultrasound devices has been used safely in breast cancer treatment. In conjunction with external beam radiation, both types of devices have been used to heat the chest wall and both devices have demonstrated enhanced effects when compared to radiation therapy without additional hyperthermia.
Doxorubicin hydrochloride is a cytotoxic anthracycline antibiotic. The recommended single-agent dose of doxorubicin HCl (Adriamycin®) for injection is 60 to 75 mg/m2 intravenously (IV) in three-week cycles. Acute myelosuppression and long term, cumulative, cardiotoxicity (congestive heart failure) are dose-limiting. Doxorubicin is active against breast cancer as a single agent and is used with other drugs in multi-agent chemotherapy regimens. In LRR breast cancer, single agent doxorubicin achieves response rates comparable to combination chemotherapy.
Lyso-thermosensitive liposomal doxorubicin (ThermoDox®) is a temperature sensitive liposomal drug delivery system that selectively accumulates in tumors as a result of their leaky vasculature. During ThermoDox/hyperthermia therapy, the tumor is heated locally while the rest of the body remains at a normal temperature. When the liposomes encounter a temperature of 39.5°C or above, they release doxorubicin locally into the heated area. Liposomal doxorubicin is administered intravenously and, because it is particulate, will eventually be removed from circulation by the reticuloendothelial system in the liver and spleen. Pharmacokinetic data from liver cancer patients treated with radiofrequency ablation (RFA) and ThermoDox show that the major portion of exposure to ThermoDox (about 95% of the liposomal doxorubicin plasma AUC0-∞) occurs during the first six hours following the infusion, establishing this time period as optimal for application of hyperthermia. Animal studies have repeatedly shown higher tumor doxorubicin concentrations and enhanced tumor cell killing when ThermoDox is combined with hyperthermia compared to doxorubicin without hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermodox in combination with hyperthermia | Experimental | Drug: ThermoDox in combination with Microwave Hyperthermia (heat)Single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):
- Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
- Disease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:
- Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
- Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:
Key exclusion criteria (26 listed)
- Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
- Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
- Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received):
- Free (i.e., non-liposomal) or liposomal doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.
- Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
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 |
|---|---|---|
| ThermoDox in combination with Microwave Hyperthermia (heat)ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion. Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system. All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals. | Drug | Thermodox in combination with hyperthermia |
Primary outcome
To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer.
Time frame: PK collection at Cycle 1 and Cycle 2
To determine efficacy of ThermoDox in combination with Hyperthermia
Time frame: Efficacy assessed at Cycle 3, Cycle 5 and End of Treatment
1 secondary outcome
To evaluate the safety of ThermoDox in combination with Hyperthermia
Time frame: Through 6 treatment Cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 25144817Zagar TM, Vujaskovic Z, Formenti S, Rugo H, Muggia F, O'Connor B, Myerson R, Stauffer P, Hsu IC, Diederich C, Straube W, Boss MK, Boico A, Craciunescu O, Maccarini P, Needham D, Borys N, Blackwell KL, Dewhirst MW. Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer. Int J Hyperthermia. 2014 Aug;30(5):285-94. doi: 10.3109/02656736.2014.936049.
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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.
Nicholas Borys, MD study director
Imunon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ThermoDox in combination with Microwave Hyperthermia (heat) in people with Breast Cancer, run by Imunon at 6 sites in United States.
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 13 inclusion and 26 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: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer. (time frame: PK collection at Cycle 1 and Cycle 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826085, which also lists 1 linked publication.
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 30 Jan 2017.