Study of Vaginal Dilator Use After Pelvic Radiotherapy - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00789893

Purpose

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.

Condition	Intervention
Cervical Cancer Endometrial Cancer Rectal Cancer Anal Cancer	Device: Vaginal Dilator

MedlinePlus related topics: Anal Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To measure compliance with vaginal dilator use. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To explore reasons for non-compliance with use of dilators. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Device: Vaginal Dilator Participants will be instructed to use the dilators three times per week, regardless of frequency of sexual intercourse. At four time points, data will be collected during physical examination in clinic to determine vaginal dilator size, grade vaginal stenosis and assess vaginal symptoms. Pre-radiation: during consultation Post-radiation: one month ± 2 weeks follow-up from last day of radiation Post-radiation: three month ± 4 weeks follow-up from initiation of dilator use Post-radiation: six month ± 4 weeks follow-up from initiation of dilator use In addition, the patients will self-report their level of confidence with dilator use on a scale of 0-10 (0= no confidence, 10= most confidence.) They will also report the associated symptoms on data collection weekly calendars.

Groups/Cohorts

Assigned Interventions

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

Device: Vaginal Dilator

Participants will be instructed to use the dilators three times per week, regardless of frequency of sexual intercourse.

At four time points, data will be collected during physical examination in clinic to determine vaginal dilator size, grade vaginal stenosis and assess vaginal symptoms.

Pre-radiation: during consultation
Post-radiation: one month ± 2 weeks follow-up from last day of radiation
Post-radiation: three month ± 4 weeks follow-up from initiation of dilator use
Post-radiation: six month ± 4 weeks follow-up from initiation of dilator use In addition, the patients will self-report their level of confidence with dilator use on a scale of 0-10 (0= no confidence, 10= most confidence.) They will also report the associated symptoms on data collection weekly calendars.

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

Female with cervical, endometrial, rectal or anal cancer
Scheduled to begin one of the following treatments at MSKCC:
Definitive external beam radiation therapy (4500- 5040 cGy) (cervical dose)
Preoperative external beam radiation therapy of (4500-5040 cGy) followed by surgery
Postoperative external beam radiation therapy (5040 cGy)
Postoperative external beam radiation therapy (5040 cGy) with intracavitary brachytherapy (tandem and ring or Syed)(3000 cGy)
Postoperative intravaginal brachytherapy (1800-2100 cGy) (once every two weeks times three)
≥ or = to 21 years of age

Exclusion Criteria:

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.
Taking oral or topical hormonal medication.
Evidence of metastatic disease.
History of thrombocytopenia or on anticoagulant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789893

Contacts

Contact: Ethel Law, MA, RN, OCN		lawe@mskcc.org
Contact: Kaled Alektiar, MD		alektiak@mskcc.org

Locations

United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge	Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Ethel Law, MA, RN, OCN lawe@mskcc.org
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Ethel Law, MA, RN, OCN lawe@mskcc.org
Contact: Kaled Alektiar, MD alektiak@mskcc.org
Principal Investigator: Ethel Law, MA, RN, OCN
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital	Recruiting
Sleepy Hollow, New York, United States
Contact: Ethel Law, MA, RN, OCN Lawe@mskcc.org
Principal Investigator: Ethel Law, MA, RN, OCN
Memorial Sloan-Kettering at Mercy Medical Center	Recruiting
Rockville Centre, New York, United States
Contact: Ethel Law, MA, RN, OCN lawe@mskcc.org
Memorial Sloan-Kettering Cancer Center @ Suffolk	Recruiting
Commack, New York, United States, 11725
Contact: Ethel Law, MA, RN, OCN lawe@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Ethel Law, MA, RN, OCN

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Ethel Law, MA, RN, OCN )
Study ID Numbers:	08-127
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00789893
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

external beam pelvic radiation
brachytherapy

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm

Genital Diseases, Female
Endometrial Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Uterine Neoplasms
Anal cancer
Endometrial cancer
Rectal cancer
Anus Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Anus Diseases

ClinicalTrials.gov processed this record on January 16, 2009