[Supportive treatment with megestrol acetate during radio(chemo)therapy in patients with tumors in the head-neck area. A randomized study].
BACKGROUND
The value of megestrol acetate in treating tumor anorexia and cachexia of terminal patients is well known. However, the supportive effect of megestrol acetate during intensive radio-(chemo-)therapy was not investigated up to now. Therefore a randomized trial was performed including patients with advanced tumors in the head and neck region.


METHODS
From June 1991 to December 1993 a total of 64 patients were admitted to a randomized, double-blind placebo-controlled study. During and up to 6 weeks following radiotherapy patients received 160 mg/d megestrol acetate or placebo. The nutritional status (anthropometric and laboratory parameters) and the quality-of-life index according to Padilla et al. [24] were determined prior to therapy, 1, 4, 6 weeks later during radiotherapy and 12, 18 weeks after completion.


RESULTS
Sixty-one out of 64 patients were evaluable (control group: n = 30; megestrol acetate patients: n = 31). One patient refused further participation after randomization. One patient in each arm was excluded due to side effects (impotence, diarrhoea). Further side effects were not observed. In the control group the nutritional parameters (body weight, triceps skinfold) and the subjective feeling of the patients deteriorated during radiotherapy and did not restore following radiotherapy. By contrast, the patients of the megestrol acetate group were able to stabilize these parameters. This difference was most prominent in the orally nourished patients (weight loss during therapy: control group: -4.1 kg; megestrol acetate group: -0.8 kg; p = 0.004); but not in the patients fed by percutaneous endoscopically guided gastrostomy (weight loss control group: -2.4 kg; megestrol acetate group: -0.8 kg; p = 0.14).


CONCLUSIONS
In patients on radiochemotherapy megestrol acetate prevents patients from further deterioration of the nutritional status and quality of life.
Fietkau
R
R
Strahlentherapeutische Klinik, Universität Erlangen-Nürnberg.
Riepl
M
M
Kettner
H
H
Hinke
A
A
Sauer
R
R
D000886:Anthropometry; D001066:Appetite / Q000187:drug effects*; D002277:Carcinoma / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D019290:Megestrol Acetate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D013268:Stimulation, Chemical; D013997:Time Factors; D015431:Weight Loss / Q000187:drug effects
D019290:Megestrol Acetate
Supportive Behandlung mit Megestrolacetat während der Radio-(Chemo-)Therapie bei Patienten mit Tumoren im Kopf-Hals-Bereich. Eine randomisierte Studie.