A Bye1, T Ose, S Kaasa. 1. Department of Gynaecology, Norwegian Radium Hospital, Montebello, Oslo.
Abstract
BACKGROUND: A randomized clinical trial was carried out to evaluate the effect of a diet low in fat and lactose to prevent acute radiation-induced diarrhea. The effect of the diet treatment on the patients' health related quality of life was studied. METHODS:143 women with gynecological malignancies were included. The daily number and consistency of stools, use of antidiarrheal agents and quality of life measured by using the EORTC Core Quality of life Questionnaire 36 item version, were recorded before therapy, in the last week of treatment, six weeks after end of radiotherapy and every eight weeks during one year's follow up. RESULTS: Fourteen patients (23%) in the intervention group reported diarrhea during radiotherapy, compared to 32 (48%) in the control group (p < 0.01). This difference was not seen with the EORTC questionnaire. The diet intervention did not interfere with emotional and social well-being. Within the control group diarrhea was associated with higher scores on the physical functioning scale (p < 0.01), and fatigue and malaise scale (p < 0.01) indicating more pronounced dysfunction of symptoms. CONCLUSION: When measuring specific phenomena such as diarrhea in a clinical trial, the EORTC questionnaire does not seem to be as sensitive as specific trial-related instruments. Diet intervention during radiotherapy might influence the patients' ability to cope with diarrhea by giving them more control over their own situation.
RCT Entities:
BACKGROUND: A randomized clinical trial was carried out to evaluate the effect of a diet low in fat and lactose to prevent acute radiation-induced diarrhea. The effect of the diet treatment on the patients' health related quality of life was studied. METHODS: 143 women with gynecological malignancies were included. The daily number and consistency of stools, use of antidiarrheal agents and quality of life measured by using the EORTC Core Quality of life Questionnaire 36 item version, were recorded before therapy, in the last week of treatment, six weeks after end of radiotherapy and every eight weeks during one year's follow up. RESULTS: Fourteen patients (23%) in the intervention group reported diarrhea during radiotherapy, compared to 32 (48%) in the control group (p < 0.01). This difference was not seen with the EORTC questionnaire. The diet intervention did not interfere with emotional and social well-being. Within the control group diarrhea was associated with higher scores on the physical functioning scale (p < 0.01), and fatigue and malaise scale (p < 0.01) indicating more pronounced dysfunction of symptoms. CONCLUSION: When measuring specific phenomena such as diarrhea in a clinical trial, the EORTC questionnaire does not seem to be as sensitive as specific trial-related instruments. Diet intervention during radiotherapy might influence the patients' ability to cope with diarrhea by giving them more control over their own situation.
Authors: Deborah Watkins Bruner; Andrea Barsevick; Chunqiao Tian; Marcus Randall; Robert Mannel; David E Cohn; Joel Sorosky; Nick M Spirtos Journal: Qual Life Res Date: 2006-10-11 Impact factor: 4.147