A randomised controlled trial evaluating the impact of multimodal home based personalised PREhabilitation on Nutrition and PERI-operative outcomes in women with OVARian malignancy (PREPARE-OVARY study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Changes in malnutrition scores before and after the prehabilitation program will be compared between experimental and control groups, along with adherence assessment in the experimental arm.
研究概览
简要总结
Malnutrition is a well-established hallmark of cancer, with prevalence rates ranging from 25-70 percentage 1–6. In cancer patients, malnutrition results from nausea, fatigue, gastrointestinal obstruction, psychological distress, alterations in nutrient metabolism, resting energy expenditure and cytokine-mediated inflammation. Cytokine release from neoplastic processes promotes anorexia, increases resting energy expenditure, accelerates protein breakdown, and inhibits fat metabolism, leading to a rapid protein-calorie malnutrition, diminished lean body mass, and impaired physical functionality. This significantly impacts all aspects of cancer care, contributing to delayed postoperative recovery, reduced tolerance to therapy, and increased mortality rates 7. In India, cancer-specific mechanisms of malnutrition are compounded by a high baseline prevalence of malnutrition in the general population. The country accounts for 42% of underweight women, primarily due to poverty, food insecurity, limited access to healthcare, and gender inequality 8. Notably, many women in India occupy a lower social status, further exacerbating their vulnerability to malnutrition. Gynecological cancers, significantly contribute to women’s morbidity and mortality. Malnutrition affects 30-60 percentage of these women, increasing surgical risks and reducing quality of life. A study in Gujarat observed malnutrition prevalence as 88.3% among Indian women with gynecological cancers 9. Malnutrition adversely impacts treatment responses and survival rates, necessitating early identification and tailored nutritional interventions to enhance recovery and quality of life. Patients with ovarian cancer are at a significantly higher risk of malnutrition compared to those with other gynecological cancers, with protein energy malnutrition and cachexia affecting up to 81.4% of cases. Epithelial Ovarian cancers (EOC) are the most common out of all the ovarian malignancy are rising in incidence. Surgery and chemotherapy remains the mainstay of treatment. At diagnosis, 66.7% of epithelial ovarian cancer (EOC) patients are malnourished, leading to increased complications and extended hospital stays. Malnutrition correlates with shorter survival rates, necessitating comprehensive nutritional assessments and individualized treatment plans for these high-risk patients to improve outcomes in these women. Despite the recognized importance of malnutrition in cancer care, systematic nutritional screening is not yet standard practice in many institutions 10. This is primarily due to lack of an efficient, feasible modality. Malnutrition can be assessed through dietary history, physical signs, and laboratory indicators. Validated tools such as NRS-2002, MNA, MST, and PG-SGA are effective in oncological populations, with PG-SGA (Annexure II given in additional supplementary information). recommended as the gold standard11. The novel Global Leadership Initiative on Malnutrition (GLIM) has proposed new diagnostic criteria incorporating inflammation and muscle mass assessment (sarcopenia). However, the applicability of GLIM for women with EOC remains unexamined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 62.00 Year(s)(—)
- 性别
- Female
入选标准
- •1 Neoadjuvant chemotherapy followed by interval cytoreductive surgery.
- •2 Above 18 years 3 ECOG Performance Score of 0-3.
排除标准
- •1 Pre-existing inflammatory disorders such as major infections, burns, open wounds, fistulas, acute trauma, chronic organ diseases like congestive heart failure, rheumatoid arthritis, chronic kidney or liver disease, or AIDS.
- •2 Pre-diagnosed myopathy, malabsorption syndromes, recent pulse steroid therapy or major surgery within the past 30 days, a final pathological diagnosis of benign disease, planned primary cytoreduction for newly diagnosed epithelial ovarian cancer (EOC), recurrent ovarian cancer, non-epithelial ovarian malignancies, or those undergoing palliative care.
结局指标
主要结局
Changes in malnutrition scores before and after the prehabilitation program will be compared between experimental and control groups, along with adherence assessment in the experimental arm.
时间窗: An 8-week home-based prehabilitation program starting after the first chemotherapy cycle will evaluate its effects on clinical, nutritional, and functional outcomes.
Short-term surgical outcomes—including hospital stay, blood loss, transfusion needs, and 30-day complications (Clavien-Dindo classification)—will also be analyzed
时间窗: An 8-week home-based prehabilitation program starting after the first chemotherapy cycle will evaluate its effects on clinical, nutritional, and functional outcomes.
次要结局
未报告次要终点
研究者
Dr Seema Singhal
All India Institute of Medical Sciences New Delhi
