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Chapter 2A: Measuring Cancer Anorexia/Cachexia: A Case Study: Protocol Background
 

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1.1 Treatment

1.11 Cancer anorexia and cachexia are multifactorial problems that affect up to 87% of  patients with some malignant diseases (Laszlo and Dekken,1986). Contributing factors to these problems include (Laszlo and Dekken,1986) local effects of the cancer (e.g. gastrointestinal obstruction), (Klein et al., 1986) systemic effects of malignant disease that may suppress appetite centrally, increased basal metabolic rate, or alter substrate utilization more (Nixon, 1986) and local or systemic effects of cancer treatment. Cachexia has been blamed for 22% of cancer deaths in a series of 400 autopsies and was implicated as an ancillary contributor to death in many additional patients (Laszlo and Dekken,1986). Nutritional impairment correlates with the response to therapy and may be directly related to therapeutic results and severity of treatment-related toxicity.

1.12 Multiple interventions have been attempted to try to treat cancer anorexia and cachexia. Enteral and parenteral nutrition procedures will increase caloric intake but these methods are cumbersome, expensive, and uncomfortable. In randomized trials they have not been clearly demonstrated to improve long-term outlook for cancer patients or the immediate results of specific treatment interventions (Klein et al.,1986; Nixon, 1986). A simple nontoxic medical reversal of cancer anorexia and cachexia would be of considerable value in the symptomatic and supportive management of the cancer patients and could possibly supplement effectiveness of other therapeutic efforts. In 1987, the NCCTG and Mayo Clinic initiated a trial studying cyproheptadine in patients with cancer anorexia and cachexia. This trial suggested that there was a mild appetite stimulation from cyproheptadine but this did not translate into any significant positive weight gain (Kardinal et al., 1990).

1.13 Megace (megestrol acetate) is a progestational agent that is frequently used at a dose of 160 mg/d in women with metastatic breast cancer. It is generally well tolerated in the vast majority of patients with the exception being that it may cause undesirable weight gain (Gregory et al.,1985; Benghiat et al.,1986; Tchekmedyian, 1987). Twenty-seven of 28 breast cancer patients, treated with higher than usual doses of Megace (480-1600 mg/d) for 6 weeks or more, gained a median of 5.1 kg (0.9-20.1 kg) (Tchekmedyian, 1987).

1.14 This weight gain effect seen in breast cancer patients has led to the use of megestrol in non-breast cancer patients with cancer cachexia (Tchekmedyian, 1987). Nine of 33 such patients gained more than 2.3 kg and 14/33 reported a subjective improvement in their sense of well-being when conventional doses (160 mg/d) of megestrol were used. In 1978, a randomized adjuvant trial of Megace (320 mg/day) versus observation was started in patients with resected primary melanoma at the Mayo Clinic. Patients receiving Megace (320 mg/d) had a 6-month median weight gain of 8.2 kg as opposed to a median weight gain of 2.6 kg in the control group (p = 0.002) (Creagan et al., 1989).

1.15 A pilot study of 14 AIDS patients who had lost 10% of their body weight suggested that Megace was beneficial (von Roenn et al., 1988). Patients on this trial gained significant amounts of weight and reported an improved sense of well being presumably related to Megace therapy. A randomized trial of this drug in AIDS patients subsequently confirmed that this drug leads to appetite stimulation and weight gain.


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