Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00006799

Purpose

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.

Condition	Intervention	Phase
Anorexia Cachexia Head and Neck Cancer Quality of Life	Drug: megestrol acetate Procedure: quality-of-life assessment	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	A Phase III, Double-Blind, Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Tonsils and Adenoids Weight Control

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date:

October 2000

Detailed Description:

OBJECTIVES:

Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy.
Determine whether health-related quality of life improves in patients treated with megestrol.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy.
Arm II: Patients receive oral placebo daily according to the schedule for megestrol in arm I.

Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8, 12, and 16 weeks after completion of radiotherapy.

PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study within 14 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006799

Locations

United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Kathryn M. Greven, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00006799 History of Changes
Other Study ID Numbers:	CDR0000068329, CCCWFU-97300, CCCWFU-0009, CCCWFU-BG00-228, NCI-P00-0174
Study First Received:	December 6, 2000
Last Updated:	August 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

untreated metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage I squamous cell carcinoma of the lip and oral cavity
stage I basal cell carcinoma of the lip
stage I verrucous carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage II basal cell carcinoma of the lip
stage II verrucous carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity

stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage I squamous cell carcinoma of the oropharynx
stage I lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx

Additional relevant MeSH terms:

Anorexia
Cachexia
Head and Neck Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Neoplasms by Site
Neoplasms
Megestrol Acetate
Megestrol

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 12, 2012