NCT00006799

Brief Summary

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss caused by cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 28, 2003

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

December 6, 2000

Last Update Submit

September 7, 2021

Conditions

AnorexiaCachexiaHead and Neck CancerQuality of Life

Keywords

untreated metastatic squamous neck cancer with occult primarymetastatic squamous neck cancer with occult primary squamous cell carcinomastage I squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage I verrucous carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage II basal cell carcinoma of the lipstage II verrucous carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III verrucous carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage I squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityanorexiacachexiaquality of life

Interventions

megestrol acetateDRUG
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven resected or unresectable stage I-IV epithelial head and neck cancer * Must be scheduled to receive a total dose of radiotherapy of at least 5,000 cGy in fraction sizes of no greater than 200 cGy * No distant metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No history of congestive heart failure or thromboembolic events * No uncontrolled hypertension, active thromboembolic disease, or myocardial infarction within the past 3 months Pulmonary: * No history of pulmonary edema Other: * No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No feeding tube * No preexisting or uncontrolled diabetes with glycosylated hemoglobin greater than 10% * No history of Cushing's syndrome * No dietary restriction (salt, sugar, or lipid) * No serious medical or psychiatric illness that would preclude study * No significant ascites, pleural effusions, or edema that may inhibit oral food intake or invalidate weight measurements * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed Endocrine therapy: * At least 1 year since prior corticosteroids, estrogens, progestins, or any other steroid hormone * No concurrent estrogens or other progestins * Concurrent glucocorticoid replacement (10 mg of prednisone a day) allowed only if patient experiences moderate "stress" (e.g., infection, trauma, or fluid loss sufficient to require hospitalization and/or IV fluid replacement) Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the head and neck Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

AnorexiaCachexiaHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, Olfactory

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightThinnessNeoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kathryn M. Greven, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2000

First Posted

July 28, 2003

Study Start

October 1, 2000

Primary Completion

September 6, 2002

Study Completion

September 6, 2002

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(1)