Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
Condition: Anorexia; Cachexia; Head and Neck Cancer; Quality of Life
MeSH terms: Head and Neck Neoplasms; Wasting Syndrome; Anorexia; Cachexia
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): megestrol acetate; quality-of-life assessment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Megestrol; Megestrol Acetate
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: 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; stage I squamous cell carcinoma of the nasopharynx; stage I lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I verrucous carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage II verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage I inverted papilloma of the paranasal sinus and nasal cavity; stage I midline lethal granuloma of the paranasal sinus and nasal cavity; stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II inverted papilloma of the paranasal sinus and nasal cavity; stage II midline lethal granuloma of the paranasal sinus and nasal cavity; stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III inverted papilloma of the paranasal sinus and nasal cavity; stage III midline lethal granuloma of the paranasal sinus and nasal cavity; stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity; anorexia; cachexia; quality of life