Anal CarcinomaPhase 2NCT07407647
Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
A Phase 2 study testing Biospecimen Collection, Prasterone and Survey Administration in people with Anal Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Anal Carcinoma, Cervical Carcinoma, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Biospecimen Collection, Prasterone and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after treatment is completed)
- Concurrent or prior chemotherapy is allowed
- Any prior gynecologic surgery is permitted
- Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
- Subject must be menopausal, which is defined as age > 50 with no menses for 12 months or bilateral oophorectomy
Who cannot join
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Patients who have received prior pelvic radiation
- Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)
- Endometrial cancer or endometrial hyperplasia
- Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry
- Use of estrogen pellet or progestin injectable drug within 6 months before study entry
Show all 11Show fewer
- Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeks before study entry
- Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +/- progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such as black cohosh in the 4 weeks before study entry. Intravaginal moisturizers and lubricants prior to enrollment are permitted
- History of breast cancer
- Patients receiving palliative radiation therapy
- Patients who do not meet criteria for menopause
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Allison M. Quick, MD, 614-293-8415, Allison.Quick@osumc.edu
Allison M. Quick, MD
About this study
Official title: Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of the vagina and symptoms including vaginal dryness, vaginal burning and itching, vaginal bleeding, pain or burning during urination, and pain during sexual intercourse. DHEA is a type of hormone replacement therapy. It is use to improve symptoms in women during menopause and may be effective in treating these symptoms for women who have received radiation.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility and tolerability of dehydroepiandrosterone (DHEA) in the post radiation setting for women with gynecologic and gastrointestinal cancers.
SECONDARY OBJECTIVES:
- To identify changes from baseline to post-radiation in the vaginal microbiome in women with gynecologic and gastrointestinal cancers receiving vaginal DHEA.
II. To identify those who may respond to vaginal DHEA based on their pretreatment microbiome.
III. To correlate changes in vaginal exam findings, sexual function, and quality of life with changes in the vaginal microbiome.
OUTLINE:
Patients receive DHEA vaginally once daily (OD) for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study.
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Rectal Carcinoma, Vaginal Carcinoma, Vulvar Carcinoma
- Being tested
- Biospecimen Collection, Prasterone, Survey Administration
- Medical subject headings
- Anus Neoplasms, Uterine Cervical Neoplasms, Rectal Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo vaginal swab sample collection
PrasteroneDrug
Also called 17-Hormoforin, Dehydroepiandrosterone, Dehydroisoandrosterone, DHEA
Given vaginally
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (DHEA) | Experimental | Patients receive DHEA vaginally QD for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Drug: Prasterone; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2 or higher adverse events
Will consider this study feasible if 80% of participants are able to complete 12 weeks of dehydroepiandrosterone (DHEA) without grade 2 or higher adverse events other than vaginal discharge or due to vaginal discharge that is felt to be too bothersome to the participant.
Measured: From start of treatment to 12 weeks
Secondary outcomes (7)
Change in vaginal microbiome
RNA sequencing of vaginal swab samples will be performed. The RNA sequencing will measure quantities of microbes.
Measured: From baseline to 12 weeks
Change in vaginal exam findings (diameter)
Vaginal diameter will be assessed using vaginal dilators ranging in size from small, medium, and large.
Measured: From baseline to 12 weeks
Change in vaginal exam findings (length)
Vaginal length will be determined by measuring from vaginal cuff, apex, or cervix to posterior fourchette (mark will be made on dilator in the vagina and then measured when dilator is removed). If a dilator cannot be placed, a cotton swab will be placed into the vagina due to stenosis or poor patient tolerance and measured at the level of the posterior fourchette.
Measured: From baseline to 12 weeks
Change in sexual function
Sexual function will be measured using the Female Sexual Functioning Index (FSFI).The FSFI is a 19-item self -reported instrument that has been previously validated to measure sexual functioning in women in clinical trials. It measures six domains of sexual functioning including arousal, orgasm, satisfaction and pain. Overall test-retest reliability coefficients are high for each domain, and the internal consistency is high with a Cronbach's alpha of 0.82 and higher. The total maximum score is 36 with a higher score indicating better functioning.
Measured: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vaginal Assessment Scale)
The Vaginal Assessment Scale (VAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
Measured: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vulvar Assessment Scale)
The Vulvar Assessment Scale (VuAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
Measured: From baseline to 12 weeks
Change in Sexual Distress
Sexual distress will be measured using the Female Sexual Distress Scale Revised (FSDS-R), which has been shown to effectively measure sexually related personal distress in women. Higher scores indicate more distress. The revised version with 13 items was used in this study.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start12 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Quick, Ohio State University Comprehensive Cancer Center
- Investigators
- Allison M Quick, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407647
- Sponsor's protocol ID
- OSU-25055
- Other IDs
- NCI-2026-00035
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
- ClinicalTrials.gov ID
- NCT07407647
- Acronym / sponsor ID
- OSU-25055
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Rectal Carcinoma, Vaginal Carcinoma, Vulvar Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- 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 phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of the vagina and symptoms including vaginal dryness, vaginal burning and itching, vaginal bleeding, pain or burning during urination, and pain during sexual intercourse. DHEA is a type of hormone replacement therapy. It is use to improve symptoms in women during menopause and may be effective in treating these symptoms for women who have received radiation.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility and tolerability of dehydroepiandrosterone (DHEA) in the post radiation setting for women with gynecologic and gastrointestinal cancers.
SECONDARY OBJECTIVES:
- To identify changes from baseline to post-radiation in the vaginal microbiome in women with gynecologic and gastrointestinal cancers receiving vaginal DHEA.
II. To identify those who may respond to vaginal DHEA based on their pretreatment microbiome.
III. To correlate changes in vaginal exam findings, sexual function, and quality of life with changes in the vaginal microbiome.
OUTLINE:
Patients receive DHEA vaginally once daily (OD) for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (DHEA) | Experimental | Procedure: Biospecimen Collection, Drug: Prasterone, Other: Survey AdministrationPatients receive DHEA vaginally QD for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after treatment is completed)
- Concurrent or prior chemotherapy is allowed
- Any prior gynecologic surgery is permitted
- Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
- Subject must be menopausal, which is defined as age > 50 with no menses for 12 months or bilateral oophorectomy
Key exclusion criteria (11 listed)
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Patients who have received prior pelvic radiation
- Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)
- Endometrial cancer or endometrial hyperplasia
- Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo vaginal swab sample collection | Procedure or surgery | Supportive care (DHEA) |
| PrasteroneAlso: 17-Hormoforin, Dehydroepiandrosterone, Dehydroisoandrosterone, DHEAGiven vaginally | Drug | Supportive care (DHEA) |
| Survey AdministrationAncillary studies | Other | Supportive care (DHEA) |
Primary outcome
Incidence of grade 2 or higher adverse events
Time frame: From start of treatment to 12 weeks
Will consider this study feasible if 80% of participants are able to complete 12 weeks of dehydroepiandrosterone (DHEA) without grade 2 or higher adverse events other than vaginal discharge or due to vaginal discharge that is felt to be too bothersome to the participant.
7 secondary outcomes
Change in vaginal microbiome
Time frame: From baseline to 12 weeks
Change in vaginal exam findings (diameter)
Time frame: From baseline to 12 weeks
Change in vaginal exam findings (length)
Time frame: From baseline to 12 weeks
Change in sexual function
Time frame: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vaginal Assessment Scale)
Time frame: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vulvar Assessment Scale)
Time frame: From baseline to 12 weeks
Change in Sexual Distress
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- The JameslineLink provided by the sponsor.
Related trials for Anal Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
The Ohio State University Comprehensive Cancer Center contact
Allison M Quick, MD principal investigator
Ohio State University Comprehensive Cancer Center
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 Biospecimen Collection, Prasterone and Survey Administration in people with Anal Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 2 or higher adverse events (time frame: From start of treatment to 12 weeks). 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 21 Apr 2026.