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Progestin
Arm 1 - Megestrol for Endometrial Cancer (MA-EEC Trial)
Phase 1
Waitlist Available
Led By Bojana Djordjevic, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
MA-EEC Trial Summary
This trialstudies pre-op progestin therapy for endometrial cancer patients to see if it helps shrink the tumor. Histology and clinical/molecular data will be compared.
Eligible Conditions
- Endometrial Cancer
MA-EEC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biopsy
Secondary outcome measures
Correlations between response to progestin and clinical, histological and transcriptomic pre-operative biomarkers that may impact therapy planning.
Side 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
MA-EEC Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1 - MegestrolExperimental Treatment1 Intervention
All study participants will receive Megestrol acetate, 160 mg daily (two 40mg tablets twice a day), for a minimum of 18 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Megestrol acetate
FDA approved
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,617 Total Patients Enrolled
2 Trials studying Endometrial Cancer
90 Patients Enrolled for Endometrial Cancer
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
9,180 Total Patients Enrolled
Bojana Djordjevic, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to medroxyprogesterone acetate in the past.Your family has a history of blood clots.You have smoked the equivalent of 20 or more packs of cigarettes per year.You have had a blood clot in a vein before, like in your leg or lung.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Megestrol
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How hazardous is the administration of Megestrol to human subjects in Arm 1?
"Given the early stage of this trial, there is limited evidence in support of the safety and efficacy of Megestrol treatment. Our team at Power have thus assigned a score of 1 to Arm 1 - Megestrol."
Answered by AI
Are there currently any avenues for prospective participants to join this investigation?
"Affirmative. Visible on clinicaltrials.gov, this experiment began recruiting patients after being posted on July 5th 2022 and was last edited November 14th 2022. In total, 73 participants are required from a single medical facility."
Answered by AI
What is the current recruitment number for this scientific experiment?
"Affirmative. The information on clinicaltrials.gov confirms that this medical trial is actively seeking participants. It was initially posted on July 5th 2022 and the most recent update took place November 14th 2022, with 73 candidates needed from one location."
Answered by AI
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