Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
Condition: Cancer of Breast; Cancer Colon
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness of perioperative oral nutrition
      supplementation (ONS) on nutritional status in malnourished cancer patients undergoing
      elective surgery.

      The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is
      effective on improving nutritional status. An extended period of 3 months post-operative ONS
      feeding is effective on improving nutritional status as compared to ONS feeding
      post-operatively during hospital stay only. Perioperative feeding is effective on improving
      secondary outcomes such as sleep quality, post-operative complications and length of hospital
      stay.
    

Detailed description: 
      The main objective of this study is to evaluate the effectiveness of perioperative oral
      nutrition supplementation (ONS) on nutritional status in malnourished cancer patients
      undergoing elective surgery.

      The specific objectives are:

        1. To evaluate the baseline nutritional status of cancer patients undergoing elective
           surgery

        2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in
           malnourished surgical cancer patients

        3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after
           discharge versus ONS feeding only post-operatively during hospital on nutritional status

        4. To evaluate secondary outcomes of perioperative feeding such as sleep quality,
           post-operative complications and length of hospital stay

      Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will
      be conducted on malnourished cancer patients undergoing elective surgery.

      Study duration: The participation duration for each participant is 4 months. The completion
      of the study will take around 30 months.
    

Intervention name(s): ONS Pre-op + ONS Post-op; ONS Pre-op + ONS Post-op + ONS Post-op 3 months; Usual intake Pre-op + ONS Post-op
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.; Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.; Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care