MalignanciesNCT01404728
Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy
An observational study of Malignancies and Stenosis of Vagina, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies, Stenosis of Vagina
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2013to 1 Mar 2017
- 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: Women being treated for pelvic malignancies in the primary care clinic.
Who may be able to join
- Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma.
- Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies.
- May have early-stage or locally advanced (node positive) disease.
- Male partners of the female subjects are also consented for this study.
Who cannot join
- Subject may not have evidence of metastatic disease.
- Prior pelvic radiation therapy
- Prior hysterectomy (not for current diagnosis)
- Diagnosis of prior malignancy, except non-melanoma skin cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy
This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.
Read the detailed description
Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.
- Conditions
- Malignancies, Stenosis of Vagina
- Keywords
- Vaginal length, Sexual dysfunction
- Medical subject headings
- Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Malignancies | Women with Vaginal Stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)
Observation of change in vaginal length will be measured at baseline (which for the patients in the radiation group will be prior to any pelvic radiation therapy and for patients in the surgery group this will be at the first post-operative visit), as well as in follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.
Measured: Up to 24 Months
Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)
The baseline SAQ will be administered prior to radiation therapy for the pelvic malignancy group and it will be administered at the post-operative visit for the surgery only group, and the post-treatment SAQ version will be given at the follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study start8 Jan 2013
- Primary completion22 Jan 2013
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Fisher, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404728
- Sponsor's protocol ID
- 11-0454.cc
- Status last verified
- Apr 2017
- First submitted
- 26 Jul 2011
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy
- ClinicalTrials.gov ID
- NCT01404728
- Acronym / sponsor ID
- 11-0454.cc
- Conditions
- Malignancies, Stenosis of Vagina
- Keywords
- Vaginal length, Sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 22 Jan 2013 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 28 Jul 2011 (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 study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.
Detailed description
Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Malignancies | – | –Women with Vaginal Stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women being treated for pelvic malignancies in the primary care clinic.
Key inclusion criteria (4 listed)
- Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma.
- Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies.
- May have early-stage or locally advanced (node positive) disease.
- Male partners of the female subjects are also consented for this study.
Key exclusion criteria (4 listed)
- Subject may not have evidence of metastatic disease.
- Prior pelvic radiation therapy
- Prior hysterectomy (not for current diagnosis)
- Diagnosis of prior malignancy, except non-melanoma skin cancer.
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
Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)
Time frame: Up to 24 Months
Observation of change in vaginal length will be measured at baseline (which for the patients in the radiation group will be prior to any pelvic radiation therapy and for patients in the surgery group this will be at the first post-operative visit), as well as in follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.
Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)
Time frame: Up to 24 Months
The baseline SAQ will be administered prior to radiation therapy for the pelvic malignancy group and it will be administered at the post-operative visit for the surgery only group, and the post-treatment SAQ version will be given at the follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.
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 1 May 2017.
- 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.
Christine Fisher, MD principal investigator
University of Colorado, Denver
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 Malignancies and Stenosis of Vagina, run by University of Colorado, Denver 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 4 inclusion and 4 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 1 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.
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?
Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator) (time frame: Up to 24 Months). 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?
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 1 May 2017.