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

This study has been completed.

Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Cancer-Related Problem/Condition
Head and Neck Cancer
Drug: megestrol acetate
Procedure: quality-of-life assessment
Phase III

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

Drug Information available for:   Megestrol acetate    Megestrol    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Kathryn M. Greven, MD     Wake Forest University    
  More Information


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

Study ID Numbers:   CDR0000068329, CCCWFU-97300, CCCWFU-0009, CCCWFU-BG00-228, NCI-P00-0174
First Received:   December 6, 2000
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00006799
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Squamous cell carcinoma
Salicylsalicylic acid
Sodium Salicylate
Cachexia
Quality of Life
Carcinoma, Basal Cell
Granuloma
Megestrol
Adenoid cystic carcinoma
Carcinoma
Epidermoid carcinoma
Body Weight
Nasopharyngeal carcinoma
Carcinoma, Adenoid Cystic
Metastatic squamous neck cancer with occult primary
Head and Neck Neoplasms
Weight Loss
Carcinoma, squamous cell
Anorexia
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Papilloma
Megestrol Acetate

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on November 20, 2008




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