Arm 1 - Megestrol for Endometrial Cancer

Sunnybrook Health Sciences, Toronto, Canada
Endometrial CancerMegestrol Acetate - Drug
Eligibility
18+
Female

Study 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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
Chemotherapy
1
Phase Ib (megestrol acetate, ipatasertib)
1
Atezolizumab

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3 years

2 years
Biopsy
3 years
Correlations between response to progestin and clinical, histological and transcriptomic pre-operative biomarkers that may impact therapy planning.

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

2
Chemotherapy
1
Phase Ib (megestrol acetate, ipatasertib)
1
Atezolizumab

Side Effects for

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Arm 1 - Megestrol
1 of 1

Experimental Treatment

73 Total Participants · 1 Treatment Group

Primary Treatment: Arm 1 - Megestrol · No Placebo Group · Phase 1

Arm 1 - Megestrol
Drug
Experimental Group · 1 Intervention: Megestrol Acetate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Megestrol Acetate
2007
Completed Phase 3
~540

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
615 Previous Clinical Trials
1,470,493 Total Patients Enrolled
2 Trials studying Endometrial Cancer
90 Patients Enrolled for Endometrial Cancer
Ontario Institute for Cancer ResearchOTHER
21 Previous Clinical Trials
8,973 Total Patients Enrolled
Bojana Djordjevic, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Danielle Vicus, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre

Eligibility Criteria

Age 18+ · Female Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top