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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
Must not have
Chemotherapy for EC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am receiving chemotherapy for esophageal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor Ki-67 proliferation index
Secondary study objectives
Histologic response of eosinophilic cytoplasm
Histologic response of gland cellularity
Primary Myelofibrosis
+3 more

Side effects data

From 2013 Phase 2 trial • 31 Patients • NCT00483327
57%
Hemorrhage, GU: Vagina
30%
Weight gain
23%
Fatigue (asthenia, lethargy, malaise)
23%
Pain: Head/headache
23%
Nausea
23%
Pain: Abdomen NOS
17%
Distension/bloating, abdominal
17%
Mood alteration: Depression
13%
Gastrointestinal - Other: Increased Appetite
13%
Dyspnea (shortness of breath)
13%
Insomnia
13%
Urinary frequency/urgency
10%
Hot flashes/flushes
10%
Constipation
10%
Mood alteration: Anxiety
10%
Constitutional Symptoms - Other: thirst
10%
Neuropathy: sensory
10%
Pain: Back
7%
Dry skin
7%
Hypertension
7%
Pain - Other: side of body
7%
Pain: Chest/thorax NOS
7%
Pain: Throat/pharynx/larynx
7%
Sweating (diaphoresis)
7%
Vaginal discharge (non-infectious)
3%
Confusion
3%
Anorexia
3%
Glucose, serum-low (hypoglycemia)
3%
Pain: Neuralgia/peripheral nerve
3%
Allergic reaction/hypersensitivity (including drug fever)
3%
Edema: head and neck:
3%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
3%
Flu-like syndrome
3%
Dysphagia (difficulty swallowing)
3%
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
3%
Thrombosis/thrombus/embolism
3%
Cystitis
3%
Diarrhea
3%
Flatulence
3%
Dizziness
3%
Flushing
3%
Hypotension
3%
Irregular menses (change from baseline)
3%
Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
3%
Dermatology/Skin - Other: skin peeling
3%
Pain: Vagina
3%
Urticaria (hives, welts, wheals)
3%
Libido
3%
Memory impairment
3%
Musculoskeletal/Soft Tissue - Other: Spasm
3%
Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial
3%
Odor (patient odor)
3%
Renal/Genitourinary - Other: Burning With Urination
3%
Vomiting
3%
Mood alteration: Agitation
3%
Pruritus/itching
3%
Pain: Pain NOS
3%
Rigors/chills
3%
pain: stomach
3%
Pain: Extremity-limb
3%
Pain: Muscle
3%
Pain: Pleura
3%
Proteinuria
3%
Rash/desquamation
3%
Rash: acne/acneiform
3%
Dermatology/Skin - Other: blister
3%
Pain: Pelvis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Megestrol Acetate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
605 Previous Clinical Trials
1,923,561 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,536 Total Patients Enrolled
11 Trials studying Endometrial Hyperplasia
3,571 Patients Enrolled for Endometrial Hyperplasia
Thanh H DellingerPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

Megestrol Acetate (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT03671811 — Phase 2
Endometrial Hyperplasia Research Study Groups: Arm II (megestrol acetate), Arm I (pterostilbene, megestrol acetate)
Endometrial Hyperplasia Clinical Trial 2023: Megestrol Acetate Highlights & Side Effects. Trial Name: NCT03671811 — Phase 2
Megestrol Acetate (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03671811 — Phase 2
~1 spots leftby Mar 2025
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