Lung CancerPhase 2NCT00691132

Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers

A Phase 2 study testing phenethyl isothiocyanate in people with Lung Cancer and Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes. PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well it works in preventing lung cancer in smokers. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Lung Cancer, Tobacco Use Disorder
What is being tested?: phenethyl isothiocyanate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Jan 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Initial from phone interview:
Currently smoking 10-45 cigarettes per day for the past year;
Between the ages of 21 and 70 years;
In apparently good physical health with no unstable medical conditions including seizures or cancer;
In stable and good mental health, i.e., currently do not experience unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria, during the past six months;
Not using any other tobacco or nicotine-containing products;

Show all 22Show fewer

Not on methadone maintenance or stimulants such as ephedra; not a regular user of street drugs and if uses occasionally, willing to abstain during the study; not taking any drugs known to be P4501A6 substrates such as phenobarbital, rifampicin, dexamethasone, ketoconazole, methoxsalen, pilocarpine, or tranylcypromine due to their role in NNK metabolism;
Does not average more than 21 alcoholic drinks per week;
Willing to perform study activities such as having blood sample drawn, urine collection, multiple clinic visits;
For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months.
For enrollment in the Short-Term Trial:
Subjects who are generally healthy with liver enzyme and blood count values within the ranges shown below based on blood samples drawn at the second screening visit. Specifically:
White blood cells ≥ 3,000/mL
Total bilirubin ≤ 1.5 x upper limits of normal (ULN)
AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
BUN and serum creatinine ≤ 1.5 x ULN
For enrollment in the Long-Term Trial:
Participated in the short-term trial and invited to participate in the long-term trial;
Possess the GSTM1 null-null genotype;
Smoke 20 or more cigarettes/day with a cumulative smoking history of 20 or more pack-years (one pack-year equals to smoking a pack of cigarettes a day for one year);
Normal liver enzymes based on blood sample drawn during 1 month wash-out;
Determined to be a good candidate for the bronchoscopy procedure by a primary care physician.

Who cannot join

Subjects with uncontrolled hypertension, uncontrolled diabetes mellitus, unstable coronary artery disease, history of cancer other than non-melanoma skin cancer, and pregnant or lactating women will not be eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Randomized Trial of PEITC as a Modifier of NNK Metabolism in Smokers

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.

PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well it works in preventing lung cancer in smokers.

Read the detailed description

OBJECTIVES:

Primary

To determine whether oral phenethyl isothiocyanate (PEITC) affects urinary levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolism in current smokers.

Secondary

To determine the effect of GSTM1 genotype on PEITC's impact on urinary biomarkers of NNK metabolism.
To determine the effect of GSTM1 genotype on the metabolism and excretion of PEITC as measured by urinary levels of its major metabolite.
To determine whether oral PEITC affects molecular markers of cell proliferation (Ki-67) and apoptosis (caspase-3 and TUNEL) in bronchial tissue.

OUTLINE: Patients are stratified according to GST genotypes (GSTM1 null-null genotype vs GSTM1-positive genotype). All participants are initially enrolled in the short-term trial. After the completion of the short-term trial, only those participants meeting certain criteria may proceed to the long-term trial.

Short-term trial: Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
Arm II: Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.

After completion of the short-term trial, participants undergo a wash-out period for 1 month in which they are asked to resume smoking regular cigarettes. Participants are offered smoking cessation assistance, if desired. Only those participants meeting certain criteria may proceed to the long-term trial after the 1-month wash-out period.

Long-term trial: Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants receive oral PEITC twice daily for 12 months.
Arm II: Participants receive oral placebo twice daily for 12 months. Participants in both arms complete a 3-day food diary monthly for 12 months and a food-frequency questionnaire at baseline and at the completion of study treatment.

All participants undergo blood and urine sample collection periodically for laboratory studies. Participants enrolled in the long-term trial also undergo bronchoscopy and tissue biopsy at baseline and at the completion study treatment. Urine samples are examined by liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) for various biomarkers. Tissue samples are examined by IHC for Ki-67, TUNEL, and caspase-3 expression.

Conditions: Lung Cancer, Tobacco Use Disorder
Being tested: phenethyl isothiocyanate, placebo
Keywords: non-small cell lung cancer, small cell lung cancer, tobacco use disorder
Medical subject headings: Lung Neoplasms, Tobacco Use Disorder, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

phenethyl isothiocyanateDrug
Also called PEITC
Given orally
placeboOther
Given orally

Study groups in NCT00691132
Study group	Role	What they receive
PEITC - Placebo (short-term trial)	Experimental	Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken. Receives: Drug: phenethyl isothiocyanate; Other: placebo
Placebo - PEITC (short-term trial)	Experimental	Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I. Receives: Drug: phenethyl isothiocyanate; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Urinary Levels of Biomarkers of NNK Metabolism
Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.
Measured: 2 periods, 5 days each on PEITC or Placebo, with washout week between
Urinary Levels of Biomarkers of NNK Metabolism
The ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.
Measured: After 5 days of treatment

Secondary outcomes (4)

Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.
Measured: After 5 days of PEITC treatment
Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.
Measured: After 5 days of treatment
Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Measured: After 5 days of treatment
Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.
% Difference in ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%
Measured: After 5 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jan 2013

First posted5 Jun 2008 (estimated)
Study startFeb 2009
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe 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: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00691132
Sponsor's protocol ID: 2007NT127
Other IDs: R01CA122244, 0712M22651
Status last verified: Apr 2017
First submitted: 4 Jun 2008
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Yuan JM, Stepanov I, Murphy SE, Wang R, Allen S, Jensen J, Strayer L, Adams-Haduch J, Upadhyaya P, Le C, Kurzer MS, Nelson HH, Yu MC, Hatsukami D, Hecht SS. Clinical Trial of 2-Phenethyl Isothiocyanate as an Inhibitor of Metabolic Activation of a Tobacco-Specific Lung Carcinogen in Cigarette Smokers. Cancer Prev Res (Phila). 2016 May;9(5):396-405. doi: 10.1158/1940-6207.CAPR-15-0380. Epub 2016 Mar 7.
PubMed 26951845
Dinh TN, Parat MO, Ong YS, Khaw KY. Anticancer activities of dietary benzyl isothiocyanate: A comprehensive review. Pharmacol Res. 2021 Jul;169:105666. doi: 10.1016/j.phrs.2021.105666. Epub 2021 May 12.
PubMed 33989764

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of PEITC as a Modifier of NNK Metabolism in Smokers
ClinicalTrials.gov ID: NCT00691132
Acronym / sponsor ID: 2007NT127
Conditions: Lung Cancer, Tobacco Use Disorder
Keywords: non-small cell lung cancer, small cell lung cancer, tobacco use disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2009
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 5 Jun 2008 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.

PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well it works in preventing lung cancer in smokers.

Detailed description

OBJECTIVES:

Primary

To determine whether oral phenethyl isothiocyanate (PEITC) affects urinary levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolism in current smokers.

Secondary

To determine the effect of GSTM1 genotype on PEITC's impact on urinary biomarkers of NNK metabolism.
To determine the effect of GSTM1 genotype on the metabolism and excretion of PEITC as measured by urinary levels of its major metabolite.
To determine whether oral PEITC affects molecular markers of cell proliferation (Ki-67) and apoptosis (caspase-3 and TUNEL) in bronchial tissue.

Short-term trial: Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
Arm II: Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.

Long-term trial: Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants receive oral PEITC twice daily for 12 months.
Arm II: Participants receive oral placebo twice daily for 12 months. Participants in both arms complete a 3-day food diary monthly for 12 months and a food-frequency questionnaire at baseline and at the completion of study treatment.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PEITC - Placebo (short-term trial)	Experimental	Drug: phenethyl isothiocyanate, Other: placeboParticipants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
Placebo - PEITC (short-term trial)	Experimental	Drug: phenethyl isothiocyanate, Other: placeboParticipants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Currently smoking 10-45 cigarettes per day for the past year;
Between the ages of 21 and 70 years;
In apparently good physical health with no unstable medical conditions including seizures or cancer;
In stable and good mental health, i.e., currently do not experience unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria, during the past six months;
Not using any other tobacco or nicotine-containing products;

Key exclusion criteria (1 listed)

Subjects with uncontrolled hypertension, uncontrolled diabetes mellitus, unstable coronary artery disease, history of cancer other than non-melanoma skin cancer, and pregnant or lactating women will not be eligible.

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
phenethyl isothiocyanateAlso: PEITCGiven orally	Drug	PEITC - Placebo (short-term trial), Placebo - PEITC (short-term trial)
placeboGiven orally	Other	PEITC - Placebo (short-term trial), Placebo - PEITC (short-term trial)

Primary outcome

Urinary Levels of Biomarkers of NNK Metabolism
Time frame: 2 periods, 5 days each on PEITC or Placebo, with washout week between
Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.
Urinary Levels of Biomarkers of NNK Metabolism
Time frame: After 5 days of treatment
The ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.

4 secondary outcomes

Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Time frame: After 5 days of PEITC treatment
Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Time frame: After 5 days of treatment
Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC
Time frame: After 5 days of treatment
Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.
Time frame: After 5 days of treatment

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEITC - Placebo (Short-term Trial)	53	41
Placebo - PEITC (Short-term Trial)	54	41

Primary outcome: Urinary Levels of Biomarkers of NNK Metabolism

Time frame: 2 periods, 5 days each on PEITC or Placebo, with washout week between. Geometric mean (95% Confidence Interval). Unit: pmol/mg creatinine

Measure	PEITC-Placebo n = 41	Placebo - PEITC n = 41
Period 1 - Total ITC	42.8 (37.4 to 48.9)	0.36 (0.19 to 0.54)
Period 2 - Total ITC	0.28 (0.13 to 0.46)	49.7 (43.2 to 57.2)
Period 1 - PEITC-NAC	56.7 (46.3 to 69.3)	0.27 (0.08 to 0.48)
Period 2 - PEITC-NAC	0.36 (0.01 to 0.85)	68.1 (56.6 to 81.8)

Primary outcome: Urinary Levels of Biomarkers of NNK Metabolism

Time frame: After 5 days of treatment. Geometric mean (95% Confidence Interval). Unit: pmol/mg creatinine

Measure	Placebo n = 82	PEITC n = 82
Total [pyridine-D4]NNAL	0.366 (0.286 to 0.396)	0.366 (0.285 to 0.396)
[pyridine-D4]Hydroxy acid	0.150 (0.128 to 0.175)	0.140 (0.120 to 0.163)
[pyridine-D4]Hydroxy acid :[pyridine-D4]total NNAL	0.455 (0.409 to 0.508)	0.420 (0.377 to 0.469)

Placebo vs PEITC: Mean Difference (Final Values): -7.7 (95% CI -13.8 to -1.2), p = 0.023, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Short-term Trial)	0 of 107 (0%)	66 of 107 (61.7%)	Not reported
Washout	0 of 107 (0%)	35 of 107 (32.7%)	Not reported
PEITC (Short-term Trial)	0 of 107 (0%)	107 of 107 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26951845Yuan JM, Stepanov I, Murphy SE, Wang R, Allen S, Jensen J, Strayer L, Adams-Haduch J, Upadhyaya P, Le C, Kurzer MS, Nelson HH, Yu MC, Hatsukami D, Hecht SS. Clinical Trial of 2-Phenethyl Isothiocyanate as an Inhibitor of Metabolic Activation of a Tobacco-Specific Lung Carcinogen in Cigarette Smokers. Cancer Prev Res (Phila). 2016 May;9(5):396-405. doi: 10.1158/1940-6207.CAPR-15-0380. Epub 2016 Mar 7.
Derived from this study: PubMed 33989764Dinh TN, Parat MO, Ong YS, Khaw KY. Anticancer activities of dietary benzyl isothiocyanate: A comprehensive review. Pharmacol Res. 2021 Jul;169:105666. doi: 10.1016/j.phrs.2021.105666. Epub 2021 May 12.
Individual participant dataSharing planned: No

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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.

Dorothy K. Hatsukami, PhD principal investigator

Masonic Cancer Center, University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing phenethyl isothiocyanate in people with Lung Cancer and Tobacco Use Disorder, run by University of Minnesota at 1 site 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 22 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: finished, as of the sponsor's last update on 12 May 2017. 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 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Urinary Levels of Biomarkers of NNK Metabolism (time frame: 2 periods, 5 days each on PEITC or Placebo, with washout week between). 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 NCT00691132, which also lists 2 linked publications.

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 12 May 2017.