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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006799
First Posted: July 28, 2003
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double (Participant, Investigator)
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:


Further study details as provided by Wake Forest University Health Sciences:

Enrollment: 13
Actual Study Start Date: October 2000
Study Completion Date: September 6, 2002
Primary Completion Date: September 6, 2002 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Kathryn M. Greven, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00006799     History of Changes
Other Study ID Numbers: REBACDR0000068329
CCCWFU-97300
CCCWFU-0009
CCCWFU-BG00-228
NCI-P00-0174
First Submitted: December 6, 2000
First Posted: July 28, 2003
Last Update Posted: April 19, 2017
Last Verified: August 2009

Keywords provided by Wake Forest University Health Sciences:
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:
Head and Neck Neoplasms
Anorexia
Cachexia
Wasting Syndrome
Neoplasms by Site
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants