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Nasopharyngeal Cancinoma (NPC)Phase 3NCT07796789

Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma

A Phase 3 study testing Nanocrystalline Megestrol Acetate Oral Suspension in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase III randomized, double-blind, placebo-controlled trial evaluates whether nanocrystalline megestrol acetate can reduce anorexia in patients with locally advanced nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Cancinoma (NPC)
What is being tested?
Nanocrystalline Megestrol Acetate Oral Suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
3 sitesChina
Study dates
29 Sep 2026to 29 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma, clinical stage II-III according to the American Joint Committee on Cancer (AJCC) 9th edition staging system, and planned to receive concurrent chemoradiotherapy (CCRT).
  • No prior radiotherapy to the primary tumor.
  • Induction chemotherapy may be administered at the investigator's discretion according to local guidelines.
  • Aged 18-70 years, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Able to comply with the study procedures and voluntarily provide written informed consent.
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  • Adequate organ function, defined as follows:
  • Hematologic function: neutrophil count ≥1.5 × 10⁹/L, hemoglobin ≥90 g/L, and platelet count ≥100 × 10⁹/L.
  • Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN).
  • Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, total bilirubin ≤2.0 × ULN, and serum albumin ≥30 g/L.
  • Renal function: serum creatinine ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min using the Cockcroft-Gault formula.

Who cannot join

  • Prior antitumor therapy, including chemotherapy, radiotherapy, or surgery, other than induction chemotherapy permitted according to the study protocol.
  • Pregnant or breastfeeding women.
  • Inability to comply with regular follow-up because of psychological, social, familial, or geographical factors.
  • Concurrent participation in another clinical study involving investigational treatment during the study treatment period.
  • Known allergy to any chemotherapeutic agent that may be used in the study.
  • Severe uncontrolled infection or other serious uncontrolled medical illness.
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  • Major organ dysfunction, including decompensated cardiac, pulmonary, renal, or hepatic failure, that would preclude tolerance of chemoradiotherapy.
  • Conditions that may substantially affect drug administration, distribution, metabolism, or excretion, including significant psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites, or pleural effusion.
  • Long-term use of immunosuppressive agents following organ transplantation.
  • History of another malignancy before enrollment.
  • Conditions affecting gastrointestinal absorption or oral intake, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty with food intake or requirement for enteral or parenteral nutritional support; anorexia nervosa or anorexia related to psychiatric illness; or difficulty eating because of pain.
  • Current or planned use of other medications that may increase appetite or body weight, including systemic corticosteroids (except short-term dexamethasone administered during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
  • Cushing syndrome, adrenal insufficiency, or pituitary insufficiency; poorly controlled diabetes mellitus; or uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive therapy.
  • Thromboembolic disease, ascites, or lower-extremity edema within 6 months before the first dose of study treatment; history of esophageal or gastric varices, severe gastrointestinal ulceration, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding.
  • Known hypersensitivity to any component of the study drug.
  • Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hai-Qiang Mai, PhD, MD contact

+8602087343643

maihq@sysucc.org.cn

China3 sites, 3 recruiting

  • Hunan Cancer Hospital

    Changsha

    Ya-Qian Han, MD, PhD, 008618673176667, hanyaqian@hnca.org.cn

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Qiaojuan Guo, MD, PhD, 008615080013157, guoqiaojuan@163.com

    Recruiting

  • Sun Yat-sen University Cancer Cente

    Guangzhou, Guangdong

    Hai-Qiang Mai, MD, PhD, +8602087343643, maihq@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for the Management of Concurrent Chemoradiotherapy-related Anorexia in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial

This phase III randomized, double-blind, placebo-controlled trial evaluates whether nanocrystalline megestrol acetate can reduce anorexia in patients with locally advanced nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). The study aims to confirm the clinical benefits of adding this agent to standard CCRT for improving appetite, quality of life, nutritional status, and survival outcomes.

Read the detailed description

This phase III randomized, double-blind, placebo-controlled, multicenter trial compares the efficacy and safety of nanocrystalline megestrol acetate versus placebo in prevention and management of anorexia and weight loss associated with concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (NPC). Eligible patients with newly diagnosed stage II-III NPC will be randomly assigned in a 1:1 ratio to receive either nanocrystalline megestrol acetate (5ml/day) or matching placebo for 11 weeks, in combination with standard CCRT. The study aims to evaluate whether nanocrystalline megestrol acetate can significantly reduce the proportion of patients experiencing clinically significant weight loss (>5% from baseline) at day 28 post-radiotherapy, and to assess its impact on appetite, quality of life, nutritional status, and survival outcomes.

Being tested
Nanocrystalline Megestrol Acetate Oral Suspension, Placebo
Keywords
Nasopharyngeal carcinoma, Nanocrystalline megestrol acetate, Anorexia, Weight loss
Medical subject headings
Nasopharyngeal Carcinoma, Anorexia, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanocrystalline Megestrol Acetate Oral SuspensionDrug

    Nanocrystalline megestrol acetate + Concurrent chemoradiotherapy: Nanocrystalline megestrol acetate oral suspension 625 mg (5ml) once daily orally (Week1-11) + Cisplatin 100mg/m^2 (Day 1, 22, 43 during radiotherapy).

  • PlaceboDrug

    Placebo + Concurrent chemoradiotherapy: Placebo 5ml once daily orally (Week1-11) + Cisplatin 100mg/m^2 (Day 1, 22, 43 during radiotherapy).

Study groups in NCT07796789
Study groupRoleWhat they receive
Nanocrystalline megestrol acetate groupExperimentalNanocrystalline megestrol acetate + Concurrent chemoradiotherapy
Receives: Drug: Nanocrystalline Megestrol Acetate Oral Suspension
Placebo groupPlacebo comparatorPlacebo + Concurrent chemoradiotherapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With >5% Weight Loss From Baseline at Day 28 After Completion of Radiotherapy

    The proportion of patients who experience more than 5% body weight loss compared with baseline body weight, assessed at Day 28 after completion of radiotherapy.

    Measured: Day 28 after completion of radiotherapy

Secondary outcomes (9)

  1. Change From Baseline in FAACT-A/CS12 Score

    Change from baseline in anorexia/cachexia-related symptoms will be assessed using the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT-A/CS12) to week 4, end of radiotherapy, and Day 28 after completion of radiotherapy

    Measured: 11 weeks

  2. Proportion of Patients With >5% Weight Loss From Baseline at the End of Radiotherapy

    The proportion of patients with a decrease in body weight of more than 5% from baseline body weight at the end of radiotherapy.

    Measured: 7 weeks

  3. Percent Change in Body Weight From Baseline

    Percentage change in body weight from baseline to the end of radiotherapy and day 28 after completion of radiotherapy will be calculated as [(body weight at the prespecified assessment - baseline body weight) / baseline body weight] × 100%.

    Measured: 11 weeks

  4. Quality of life (QoL)

    assessed using the EORTC Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H\&N35), version 1.0. Prespecified symptom scale and item scores will be calculated according to the EORTC scoring manual at baseline, week 4 of radiotherapy, end of radiotherapy, and day 28 after completion of radiotherapy.

    Measured: 11 weeks

  5. Quality of Life (QoL)

    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. Prespecified functional and symptom scale scores will be calculated according to the EORTC scoring manual at baseline, week 4 of radiotherapy, end of radiotherapy, and day 28 after completion of radiotherapy.

    Measured: 11 weeks

  6. Skeletal Muscle Index at the Third Lumbar Vertebra (L3-SMI)

    Change from baseline to the end of radiotherapy in skeletal muscle index at the third lumbar vertebra (L3-SMI) will be assessed using cross-sectional imaging. L3-SMI will be calculated as the skeletal muscle cross-sectional area at the L3 level normalized to height squared (cm²/m²) .

    Measured: 7 weeks

  7. Proportion of Patients Receiving a Prespecified Cumulative Dose of Concurrent Cisplatin

    The proportion of patients receiving a cumulative concurrent cisplatin dose of at least 200 mg/m² during radiotherapy and 3 cycles of concurrent cisplatin

    Measured: 7 weeks

  8. Incidence of Acute Toxicity

    The incidence and severity of acute adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of each adverse event will be reported separately.

    Measured: From the start of treatment to 90 days after completion of radiotherapy

  9. Incidence of Late Radiation Toxicity

    The incidence and severity of late radiation toxicities will be assessed according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring scheme.

    Measured: 90 days after completion of radiotherapy to 2 years after completion of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study start29 Sep 2026
  3. Primary completion29 Sep 2027 (estimated)
  4. Study completion29 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796789
Sponsor's protocol ID
2025-FXY-277
Status last verified
Oct 2026
First submitted
16 Mar 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nanocrystalline Megestrol Acetate Oral Suspension in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hai-Qiang Mai, PhD, MD (+8602087343643, maihq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With >5% Weight Loss From Baseline at Day 28 After Completion of Radiotherapy (time frame: Day 28 after completion of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07796789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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