megestrol / Generic mfg. - LARVOL DELTA

A randomized phase II trial of everolimus and letrozole or hormonal therapy in women with advanced, persistent or recurrent endometrial carcinoma: A GOG Foundation study. (PubMed, Gynecol Oncol) - "EL and MT demonstrated clinically meaningful efficacy in recurrent EC patients. The higher PFS observed in chemo-naïve patients is worthy of confirmation in future studies."

Journal • P2 data • Cardiovascular • Endometrial Cancer • Hematological Disorders • Mucositis • Oncology • Solid Tumor

Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial. (PubMed, Gynecol Oncol) - P2 | "These results support a potential role of the palbociclib-letrozole combination as treatment for hormone receptor-positive advanced/recurrent endometrial cancer. Based on these encouraging results, phase III evaluation of letrozole combined with a CDK4/6 inhibitor is planned."

Journal • Metastases • P2 data • Breast Cancer • Endometrial Cancer • Hematological Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • CCNA2 • ER

Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=204 | Recruiting | Sponsor: Sun Yat-sen University

New P3 trial • Anorexia • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Reversing sarcopenia with megestrol acetate ameliorates systemic inflammation and improves survival in NSCLC. (PubMed, Transl Oncol) - "MA is associated with reversal of sarcopenia in NSCLC patients, with a recommended regimen of 160 mg daily for at least 6 weeks. The resulting muscle improvement is a powerful predictor of survival and partially mediates the reduction of IL-6, potentially creating a more favorable tumor microenvironment for ICIs. MA serves as a strategic adjunct to immunotherapy by targeting sarcopenia."

Journal • Cachexia • Cardiovascular • Diabetes • Hematological Disorders • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcopenia • Solid Tumor • Thrombosis • IL6

Comparison of the effect of oral megestrol acetate with or without levonorgestrel-intrauterine system on fertility-preserving treatment in patients with early-stage endometrial cancer: a prospective, open-label, randomized controlled phase II trial (ClinicalTrials.gov NCT03241914). (PubMed, J Gynecol Oncol) - P2/3 | "Compared with MA alone, the addition of LNG-IUS may not improve the early CR rate for EEC, and may produce more adverse events instead."

Journal • P2 data • Endometrial Cancer • Gynecology • Hematological Disorders • Long-acting Reversible Contraceptives • Oncology • Solid Tumor • Uterine Cancer

PIONEER: A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer (clinicaltrials.gov) - P2; N=189; Recruiting; Sponsor: Cambridge University Hospitals NHS Foundation Trust; Trial completion date: Dec 2021 ➔ Nov 2022; Trial primary completion date: Sep 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AR • AURKA • CASP3 • CDH1 • ER • FN1 • HER-2 • PGR

Results of the window-of-opportunity PIONEER trial evaluating addition of the progesterone receptor (PR) agonist megestrol to letrozole for early stage estrogen receptor (ER) positive breast cancer: exploiting ER-PR interaction (SABCS 2023) - "Addition of the PR agonist megestrol enhanced the anti-proliferative effect of letrozole in this window-of opportunity trial. Megestrol combinations were well tolerated, and the anti-proliferative effect was observed in both low and high dose arms. These data support the potential use of low-dose megestrol as an inexpensive and well-tolerated means of improving aromatase inhibitor efficacy."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AR • AURKA • CASP3 • ER • HER-2 • PGR

Evaluating progesterone receptor agonist megestrol plus letrozole for women with early-stage estrogen-receptor-positive breast cancer: the window-of-opportunity, randomized, phase 2b, PIONEER trial. (PubMed, Nat Cancer) - P2 | "This effect was accompanied by reduced ER genomic binding at canonical binding sites in paired tumor biopsies, indicating reduced ER transcriptional activity. These results support further evaluation of low-dose megestrol, which has two mechanisms for potentially improving breast cancer outcomes in combination with standard antiestrogen therapy: alleviating hot flashes and thereby helping with treatment adherence, as well as a direct antiproliferative effect ( NCT03306472 )."

Journal • P2b data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PGR

Nanocrystalline Megestrol Acetate for Locally Advanced Cervical Cancer Patients Undergoing Concurrent Chemoradiotherapy: A Prospective, Randomized, Parallel-Controlled Clinical Trial (ESMO 2026) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Reassessing the Obesity Paradox in Pancreatic Adenocarcinoma: A Survival Analysis (ACG 2026) - "Cancer cachexia affects up to 85% of them, and orexigenic agents like megestrol acetate are routinely started on the assumption that maintaining BMI improves outcomes... A total of 185 patients were included. Mean OS was 17.17 months in Group A vs. 20.11 months in Group B; median OS was 15.27 vs."

Cachexia • Genetic Disorders • Obesity • Oncology • Pancreatic Adenocarcinoma • Pancreatic Ductal Adenocarcinoma • Solid Tumor

PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: Peking University People's Hospital | Not yet recruiting ➔ Recruiting

dMMR • Enrollment open • IO biomarker • Mismatch repair • Endometrial Cancer • Oncology • Solid Tumor

MEGA-TACT-BC3: Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer (clinicaltrials.gov) - P3 | N=132 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

Efficacy of combined metformin plus progestin therapy versus progestin monotherapy in endometrial hyperplasia: a randomized clinical trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Progestin monotherapy was administered as megestrol acetate 40 mg daily (atypical hyperplasia) or medroxyprogesterone acetate 10 mg/day cyclically (non-atypical). Future trials with patient stratification by metabolic and clinical characteristics may clarify subgroups that could benefit from adjunctive metformin. Iranian Registry of Clinical Trials (IRCT20230128057254N1), retrospectively registered on October 30, 2023."

Clinical • Journal • Monotherapy

Short-term outcomes of low-dose megestrol acetate on appetite and caregiver distress in advanced head and neck cancer: A prospective single-arm study. (PubMed, J Cancer Res Ther) - "Low-dose MA was associated with significant improvement in appetite and reduction in caregiver eating-related distress over a 10-day follow-up period. These findings suggest short-term symptomatic benefit and support the inclusion of caregiver-centered outcomes in supportive oncology research. Larger controlled studies with longer follow-up are warranted to validate these observations."

Journal • Observational data • Anorexia • CNS Disorders • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients (clinicaltrials.gov) - P3 | N=227 | Active, not recruiting | Sponsor: Alliance for Clinical Trials in Oncology | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Apr 2027 ➔ Apr 2026

Trial completion date • Trial primary completion date • Anorexia • Hematological Malignancies • Oncology • Solid Tumor

PKUPH-ORLPP-EC: Orlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Peking University People's Hospital

New P2 trial • Endometrial Cancer • Oncology • Solid Tumor • PGR

Nanocrystalline Megestrol Acetate Oral Suspension for the Treatment of Cancer Anorexia-Cachexia Syndrome in Advanced Non-Small Cell Lung Cancer: A Randomized, Controlled, Multicenter Study (ChiCTR) - P=N/A | N=86 | Recruiting | Sponsor: Chinese PLA General Hospital; Chinese PLA General Hospital

New trial • Anorexia • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fertility-sparing treatment in stage IA grade 2 endometrioid endometrial cancer: Outcomes of a standardized approach. (PubMed, Gynecol Oncol) - "A standardized fertility-sparing approach combining hysteroscopic resection and progestins achieved effective and safe management in stage IA grade 2 EEC without myometrial invasion, with favorable reproductive outcomes. These findings support its use in carefully selected patients, although longer follow-up is needed."

Journal • Endometrial Cancer • Gynecology • Long-acting Reversible Contraceptives • Oncology • Solid Tumor • CTNNB1 • ER • TP53

Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: New Mexico Cancer Research Alliance | Initiation date: Mar 2026 ➔ Jun 2026

Trial initiation date • Endometrial Adenocarcinoma • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer

Striving for a healthy weight - A lifelong endeavor for children diagnosed with medulloblastoma (ISPNO 2026) - "BMI and weight changes, whether gain or loss, should be carefully assessed and addressed before therapy begins and monitored across the lifespan to support the best possible outcomes for a healthy weight and lifestyle. Although megestrol was effective for weight gain, it should be used with caution in this population given the high incidence of adrenal insufficiency."

Clinical • Brain Cancer • Endocrine Disorders • Medulloblastoma • Nephrology • Obesity • Renal Disease • Solid Tumor

Indications and Efficacy of Progestogen-Monotherapy as Menopause Hormone Therapy: A Narrative Review. (PubMed, BJOG) - "Micronized progesterone shows additional benefits for sleep quality, while synthetic progestins such as medroxyprogesterone acetate, megestrol acetate, and norethindrone acetate variably confer bone protection. Its optimal use may be tailored to clinical context: micronized progesterone for sleep disturbance, norethindrone acetate for bone health, or progestins with known antineoplastic properties in hormone-sensitive tumours. Larger, high-quality studies are needed to better define long-term safety and efficacy."

Journal • Monotherapy • Review • Brain Cancer • Breast Cancer • Cardiovascular • CNS Disorders • Coronary Artery Disease • Endometrial Cancer • Endometriosis • Gynecologic Cancers • Gynecology • Hepatology • Meningioma • Oncology • Ovarian Cancer • Sarcoma • Sleep Disorder • Solid Tumor • Uterine Cancer • Venous Thromboembolism • Women's Health

Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: New Mexico Cancer Research Alliance | Not yet recruiting ➔ Recruiting

Enrollment open • Endometrial Adenocarcinoma • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer

Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101 (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: MetaFines | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2027 ➔ Jun 2028 | Initiation date: Sep 2025 ➔ May 2026 | Trial primary completion date: Mar 2026 ➔ Apr 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Cachexia • Colorectal Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: Hospital Universitari de Bellvitge | Trial completion date: Sep 2028 ➔ Jan 2035 | Initiation date: Sep 2026 ➔ Jan 2027 | Trial primary completion date: May 2027 ➔ Apr 2031

Trial completion date • Trial initiation date • Trial primary completion date • Endometrial Cancer • Genetic Disorders • Obesity • Oncology • Solid Tumor • ER • POLE • TP53

Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma (clinicaltrials.gov) - P2/3 | N=8 | Terminated | Sponsor: Xiaojun Chen | N=89 ➔ 8 | Trial completion date: Feb 2027 ➔ Feb 2026 | Recruiting ➔ Terminated; no enough enrolled patients

Enrollment change • Trial completion date • Trial termination • Endometrial Cancer • Obesity • Oncology • Solid Tumor