Low fat, low lactose diet used as prophylactic treatment of acute intestinal reactions during pelvic radiotherapy. A prospective randomised study

Purpose. The main aim of the present study was to evaluate the effect of a low fat, low lactose diet on acute and late gastrointestinal side effects of pelvic radiotherapy. We also wanted to evaluate if such a treatment would influence the patients health related quality of life (HRQOL) in any way. Background. Cancer therapies and their side effects may cause nutritional problems and malnutrition. Pelvic radiotherapy, a common treatment modality for patients with carcinoma of the endometrium or cervix, is associated with both acute and late side effects that may affect nutritional status. Acute injury may lead to impaired absorption of nutrients and fluid. The patients experience diarrhoea, weight loss, nausea and vomiting. Bile salt malabsorption may be a factor in the pathogenesis of the diarrhoea. In cases of bile salt malabsorption a low fat diet will cause decreased bile salt excretion and thereby relief of symptoms. This assumption was evaluated in a small, non-randomised study in 1985. The results indicated that a low fat diet may reduce the frequency of diarrhoea and use of anti-diarrhoeal agents during radiotherapy. These findings were regarded as promising and since nutrition management guidelines for radiation enteritis were lacking in the literature, a clinical trial was planned. Methods. The study was designed as an open randomised clinical trial and conducted at the Norwegian Radium Hospital (NRH). The intervention diet (low fat, low lactose) was to be followed during and six weeks after radiotherapy. Measurements were performed at basement, the 3rd and last week of radiotherapy, six week after and then every 8th week. The entire period was one year. In November 1993 the surviving patients were approached again and asked to complete a questionnaire package similar to the one completed during the clinical trial. The study population was recruited from the department of gynaecology at NRH. The main selection criteria were pelvic radiotherapy (dose above 40 Gy) age = 75 years and a WHO functional status = 2. Patients were consecutive included from May 1988 through May 1990 and 143 women were included. Seventy-one were assigned to the intervention diet and 72 to the control group. In November 1993, 94 women were alive without any known relapse and 79 (84%) accepted participation. The women registered use of Loperamid and the daily number and consistency of bowel movements. The data on bowel movements was categorised and used to evaluate if diarrhoea was present or not. Nutritional status was evaluated by the means of weight development, arm muscle circumference (AMC), serum transferring (STF) and serum albumin (s-Alb). Dietary intake was assessed by 48-hour recall prior to radiotherapy, 4-days unweighed dietary record during radiotherapy and 7-days weighed dietary records during follow-up. 24-hour urinary nitrogen was used to validate the food records. HRQOL was defined as the patients' self-reported subjective physical and psychosocial situation as a consequence of disease and treatment. It was measured with the EORTC Core Quality of Life Questionnaire 36-item version (EORTC QLQ-C36). Results. During the last week of radiotherapy 14 patients (23%) in the intervention group and 32 (48%) in the control group reported diarrhoea (p< 0.01). The intervention group also used less anti-diarrhoea medication than the control group, 0.6 tablets per day versus 1.1 (p<0.01). Six weeks after end of radiotherapy, no group differences were found with regard to bowel movements or medication. The intervention group had a lower energy intake than the control group during radiotherapy, 5.7 MJ versus 6.5 MJ (p<0.05). The mean daily fat intake was respectively 34.3 g and 60.1 g (p<0.001). The intervention group received a significant lower part of the energy from milk products, meats, fats and sugar than the control group, and consumed more energy from vegetables and fruits, cereals and fish. Weight loss was more pronounced in the intervention group (mean reduction of 2.6 kg versus 1.7 kg) than in the control group (ns) during treatment. Mean values of AMC, s-Alb and STF were within the reference range in both groups during the entire observation period. During the last week of radiotherapy six patients (9%) in the intervention group and 4 (6%) in the control group were mildly depleted (ns). At 12 weeks and after one year none of the patients could be categorised as malnourished. No major differences in HRQOL were found between the two groups during radiotherapy and one-year follow up. Within the control group an association between diarrhoea and deteriorated role functioning, physical functioning and fatigue was found during the last week of radiotherapy that was not found in the intervention group. Regarding late effects of radiotherapy (3-4 years after radiotherapy) both groups had more diarrhoea than in the general population, 23.8 versus 9.5 (p