Cervical CancerNCT00789893
Study of Vaginal Dilator Use After Pelvic Radiotherapy
An observational study of Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable. Read more about this study
- Who is it for?
- Ages 21 to 85 years, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Rectal Cancer
- What is being tested?
- Vaginal Dilator
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2008to Jun 2015
- 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 21 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy.
Who may be able to join
- Female with cervical, endometrial, rectal or anal cancer
- Scheduled to begin one of the following treatments at MSKCC:
- Definitive external beam radiation therapy
- Preoperative external beam radiation therapy of followed by surgery
- Postoperative external beam radiation therapy
- Definitive external beam radiation therapy with intracavitary brachytherapy (tandem and ring or Syed)± surgery
- Postoperative intravaginal brachytherapy (once every two weeks times three)
- ≥ or = to 21 years of age
Who cannot join
- Women with cervical, endometrial, rectal or anal cancer who are/have:
- Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English.
- Mental or physical handicaps that would prohibit them from full participation in the study.
- Prior radiation to the pelvis.
- Evidence of metastatic disease.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York
About this study
Official title: A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.
We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.
- Conditions
- Cervical Cancer, Endometrial Cancer, Rectal Cancer, Anal Cancer
- Being tested
- Vaginal Dilator
- Keywords
- external beam pelvic radiation, brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Rectal Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal DilatorDevice
Also called The remaining assessments will be performed during the patient's regularly, scheduled follow-up appointments or via phone calls.
Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis \& assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st \& 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, \& the 2nd will be one month ± 2 weeks from last day of radiation.
| Study group | Role | What they receive |
|---|---|---|
| Women with cervical, endometrial, rectal or anal cancer | Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy Receives: Device: Vaginal Dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure compliance with vaginal dilator use.
Measured: conclusion of study
To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.
Measured: conclusion of study
Secondary outcomes (3)
To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
Measured: conclusion of study
To explore reasons for non-compliance with use of dilators.
Measured: conclusion of study
To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ethel Law, MA, RN, OCN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789893
- Sponsor's protocol ID
- 08-127
- Status last verified
- Jun 2015
- First submitted
- 12 Nov 2008
- Last updated
- 11 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT00789893
- Acronym / sponsor ID
- 08-127
- Conditions
- Cervical Cancer, Endometrial Cancer, Rectal Cancer, Anal Cancer
- Keywords
- external beam pelvic radiation, brachytherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Nov 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.
Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.
We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with cervical, endometrial, rectal or anal cancer | – | Device: Vaginal DilatorWomen seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy.
Key inclusion criteria (8 listed)
- Female with cervical, endometrial, rectal or anal cancer
- Scheduled to begin one of the following treatments at MSKCC:
- Definitive external beam radiation therapy
- Preoperative external beam radiation therapy of followed by surgery
- Postoperative external beam radiation therapy
Key exclusion criteria (5 listed)
- Women with cervical, endometrial, rectal or anal cancer who are/have:
- Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English.
- Mental or physical handicaps that would prohibit them from full participation in the study.
- Prior radiation to the pelvis.
- Evidence of metastatic disease.
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 |
|---|---|---|
| Vaginal DilatorAlso: The remaining assessments will be performed during the patient's regularly, scheduled follow-up appointments or via phone calls.Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis \& assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st \& 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, \& the 2nd will be one month ± 2 weeks from last day of radiation. | Device | Women with cervical, endometrial, rectal or anal cancer |
Primary outcome
To measure compliance with vaginal dilator use.
Time frame: conclusion of study
To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.
Time frame: conclusion of study
3 secondary outcomes
To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
Time frame: conclusion of study
To explore reasons for non-compliance with use of dilators.
Time frame: conclusion of study
To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.
Time frame: conclusion of study
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 11 Jun 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Ethel Law, MA, RN, OCN principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 8 inclusion and 5 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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 measure compliance with vaginal dilator use. (time frame: conclusion of study). 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 11 Jun 2015.