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Progestin
Megestrol Acetate + Pterostilbene for Endometrial Cancer
Phase 2
Waitlist Available
Led By Thanh H Dellinger
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Candidate for a total hysterectomy with or without bilateral salpingo-oophorectomy
Histologically confirmed EC or complex atypical hyperplasia of the endometrium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
Study Summary
This trial is testing megestrol acetate, with or without pterostilbene, to see if it can treat endometrial cancer.
Who is the study for?
This trial is for women with endometrial cancer or complex atypical hyperplasia who are fit enough for surgery (ECOG 0-2) and have normal liver and kidney function. They must be able to swallow pills, not pregnant, without serious heart conditions, infections needing IV treatment, HIV, hepatitis B/C, recent thromboembolism/stroke/MI or taking certain supplements.Check my eligibility
What is being tested?
The study is testing the effectiveness of megestrol acetate (a chemotherapy drug) with or without pterostilbene (an antioxidant found in blueberries/grapes) in patients undergoing hysterectomy for endometrial cancer. It aims to determine if adding pterostilbene improves outcomes.See study design
What are the potential side effects?
Megestrol acetate can cause weight gain, increased blood sugar levels, and possible risk of blood clots. Pterostilbene's side effects aren't well-known but may include mild digestive issues based on its antioxidant properties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for a surgery to remove my uterus, and possibly my ovaries and fallopian tubes.
Select...
My condition is confirmed as endometrial cancer or complex atypical hyperplasia.
Select...
My kidneys are working well, as shown by tests.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor Ki-67 proliferation index
Secondary outcome measures
Histologic response of eosinophilic cytoplasm
Histologic response of gland cellularity
Primary Myelofibrosis
+3 moreSide effects data
From 2013 Phase 2 trial • 31 Patients • NCT0048332757%
Hemorrhage, GU: Vagina
30%
Weight gain
23%
Fatigue (asthenia, lethargy, malaise)
23%
Pain: Head/headache
23%
Pain: Abdomen NOS
23%
Nausea
17%
Distension/bloating, abdominal
17%
Mood alteration: Depression
13%
Dyspnea (shortness of breath)
13%
Gastrointestinal - Other: Increased Appetite
13%
Insomnia
13%
Urinary frequency/urgency
10%
Neuropathy: sensory
10%
Hot flashes/flushes
10%
Constitutional Symptoms - Other: thirst
10%
Pain: Back
10%
Constipation
10%
Mood alteration: Anxiety
7%
Vaginal discharge (non-infectious)
7%
Hypertension
7%
Dry skin
7%
Pain: Chest/thorax NOS
7%
Pain: Throat/pharynx/larynx
7%
Pain - Other: side of body
7%
Sweating (diaphoresis)
3%
Dermatology/Skin - Other: blister
3%
Rigors/chills
3%
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
3%
Cystitis
3%
Dermatology/Skin - Other: skin peeling
3%
Dysphagia (difficulty swallowing)
3%
Edema: head and neck:
3%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
3%
Flatulence
3%
Flu-like syndrome
3%
Flushing
3%
Glucose, serum-low (hypoglycemia)
3%
Hypotension
3%
Libido
3%
Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial
3%
Odor (patient odor)
3%
Pain: Extremity-limb
3%
Pain: Muscle
3%
Pain: Neuralgia/peripheral nerve
3%
Pain: Pleura
3%
Pain: Vagina
3%
Proteinuria
3%
Pruritus/itching
3%
Rash/desquamation
3%
Rash: acne/acneiform
3%
Urticaria (hives, welts, wheals)
3%
Vomiting
3%
pain: stomach
3%
Anorexia
3%
Pain: Pain NOS
3%
Thrombosis/thrombus/embolism
3%
Allergic reaction/hypersensitivity (including drug fever)
3%
Irregular menses (change from baseline)
3%
Confusion
3%
Diarrhea
3%
Dizziness
3%
Memory impairment
3%
Mood alteration: Agitation
3%
Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
3%
Musculoskeletal/Soft Tissue - Other: Spasm
3%
Renal/Genitourinary - Other: Burning With Urination
3%
Pain: Pelvis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Megestrol Acetate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (megestrol acetate)Experimental Treatment1 Intervention
Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.
Group II: Arm I (pterostilbene, megestrol acetate)Experimental Treatment2 Interventions
Patients receive pterostilbene PO BID and megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Megestrol Acetate
2007
Completed Phase 3
~540
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,416 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,598 Total Patients Enrolled
75 Trials studying Endometrial Cancer
73,374 Patients Enrolled for Endometrial Cancer
Thanh H DellingerPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a candidate for a surgery to remove my uterus, and possibly my ovaries and fallopian tubes.I am scheduled for a hysterectomy soon.I have not taken pterostilbene supplements in the last 30 days.I am receiving chemotherapy for esophageal cancer.My condition is confirmed as endometrial cancer or complex atypical hyperplasia.My kidneys are working well, as shown by tests.I am a woman who can have children and have a negative pregnancy test.I agree to have a biopsy or tissue collection during surgery after treatment.I can take care of myself and am up and about more than half of my waking hours.I haven't taken supplements like resveratrol, genistein, or quercetin in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (pterostilbene, megestrol acetate)
- Group 2: Arm II (megestrol acetate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any prior investigations revolved around Megestrol Acetate?
"Currently, there exist 7 trials for Megestrol Acetate - two of which are in the final stages. Most studies are based out of Winston-Salem, North carolina; however, they span across 85 different medical sites."
Answered by AI
What have been the findings regarding any adverse effects associated with Megestrol Acetate?
"Megestrol Acetate has been assigned a safety score of 2, as Phase 2 trials have yielded some data in support of its security but are yet to confirm efficacy."
Answered by AI
How many enrollees are involved in this experimental protocol?
"Affirmative. The information hosted on clinicaltrials.gov shows that this medical trial is actively recruiting and has been since January 21st 2019, with an update made as recently as October 12th 2022. A total of 28 patients are needed for the single-centre study."
Answered by AI
In what instances is Megestrol Acetate prescribed?
"Megestrol Acetate is a suitable treatment for palliative therapy, recurrent endometrial carcinoma, and weight loss."
Answered by AI
Are participants being accepted for the trial currently?
"According to current information posted on clinicaltrials.gov, the recruitment process for this trial is ongoing. The study was initially launched on January 21st 2019 and has been updated as recently as October 12th 2022."
Answered by AI
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