Head and neck cancer Mouth Neoplasms Gingival Neoplasms Lip Neoplasms Palatal Neoplasms Tongue Neoplasms Otorhinolaryngologic Neoplasms Ear Neoplasms Laryngeal Neoplasms Nose Neoplasms Pharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck
Conditions
Interventions
Patients will receive 20 mL of MA (Giga Oral Suspension 40mg/mL) orally once daily for the duration of their radiotherapy treatment and continue the medication for 6 weeks after the end of radiotherap
Experimental Drug,No Intervention No treatment
Megestrol Acetate arm,Control arm
Sponsors
Division of Radiation Oncology Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: User 1. Age range more than 20-year-old, 2.Good performance status with ECOG 0-1, 3.Head and neck cancer except nasopharyngeal patients who are planned to treat with radiotherapy with or without chemotherapy for definitive or postoperative setting, 4. Histologically confirmed squamous cell carcinoma of head and neck, 5.The participant or legal representative provides the written informed consent for the study, 6.Estimated life expectancy at least 6 months, 7. Participants must demonstrate the ability to adhere to study procedures and comply with the study protocol, be able to speak Thai.
Exclusion criteria
Exclusion criteria: 1.Previous radiotherapy in the head and neck area, 2.History of malignancy or current secondary malignancy at the other site ,3.The radiation field includes only primary lesions or unilateral neck irradiation, 4.Histological subtypes other than squamous cell carcinoma (e.g., Adenocarcinoma, small cell carcinoma), 5.Salivary and paranasal sinus malignancies of the head and neck area, 6.Poorly controlled hypertension (systolic pressure more than 160 mmHg and diastolic pressure more than 100 mmHg), uncontrolled diabetes mellitus, or end-stage renal disease, 7.Thromboembolism, cardiovascular diseases, such as congestive heart failure (New York Heart Association, NYHA equal to or greater III), previous myocardial infarction, unstable angina, uncontrolled arrhythmia, and previous cerebrovascular accidents., 8.Clinical edema or a predisposition to edema due to underlying conditions, including hypoalbuminemia, or cirrhosis, 9.Obesity defined as BMI equal to or greater than 30 kg/m2, 10.Women with abnormal uterine bleeding, 11.Less than 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormones except as antiemetic prior to chemotherapy, 12.Concurrent corticosteroids, estrogens, progestins, or other steroid hormones except as antiemetic prior to chemotherapy, 13.Use of other medication(s) that promote appetite such as cannabis and its derivatives, oxandrolone, or dronabinol, 14.Has metastatic disease or locoregional recurrence, 15.Hypersensitivity to megestrol acetate and its active substances, 16.Patients who cannot administrate the agents through oral or feeding tube routes, 17.Active autoimmune disease(s) that require medication within 2 years, 18.Known disease or condition that would interfere with the cooperation of the study,19.Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Body Composition Analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Body Composition Analysis ,Muscle mass At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Body Composition Analysis,Fat mass At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Body Composition Analysis,Body water At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Body Composition Analysis,Functional Assessment of Anorexia-Cachexia Therapy At week 1, 4, 6 of radiotherapy, and 6 week after radiotherapy Functional Assessment of Anorexia-Cachexia Therapy questionnaire | — |
Countries
Thailand
Contacts
Public ContactPooriwat Muangwong
Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed