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Completed

NCT Number: NCT06035510

Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery

Major surgeries including gynecological cancer surgery can make surgical stress that leads to increased burden of postoperative complications, delayed length of hospital stay and increased mortality rate. Protein is one of the essential factors that contribute to the recovery of patients following surgery, as the surgical process increases protein breakdown in the body. Providing patients with an adequate amount of protein helps enhance muscle building, aids in muscle repair, and reduces postoperative inflammation.

One study administered a fluid containing a combination of whey protein and carbohydrates to cancer patients in preoperative and postoperative periods. The result of the study shows that intervention group can reduce the length of hospital stay and postoperative complications.

However, studies focusing on the use of only-protein supplement to improve surgical complications in gynecological cancer patients are limited. This study aims to investigate the administration of protein supplement before and after surgery in gynecological cancer patients its contribution to the reduction of length of hospital stay and postoperative complications at Rajavithi Hospital.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi

Phaya Thai, ratchathewi, 10400, Thailand

About this study

During admission, Participants will be randomized by a computer program into two groups as the whey protein supplement group and control group. Both groups will undergo nutritional assessment on the first day of admission before surgery by the Rajavithi Subjective Global Assessment tool and serum albumin level.

The whey protein supplement group : participants will receive isolated whey protein in the form of two packets of isolated whey protein powder (each packet containing 11.5 grams, totaling to 23 grams) mixed with water in a 350 milliliter drinking bottle at 6.00 p.m. on first day before operation. After the operation, participants will receive the same form of protein supplement as before surgery at 6.00 a.m. on the first day after operation.

The control group : participants will receive standard care, which includes fasting from food after midnight on the night before surgery and other standard surgical protocols.

After surgery, participants will be assessed based on

  • Intraoperative outcomes, which include the duration of surgery, intraoperative blood loss, and intraoperative complications.
  • The postoperative outcomes, which include length of hospital stay, duration of stay in the intensive care unit (ICU), postoperative complications, postoperative pain, time to first ambulation , time to first flatus , nausea and vomiting symptoms, increased requests for pain medication, fever more than 24 hours after surgery , wound infection and readmission.
  • The nutritional status outcomes, assessed through serum albumin levels before surgery and on the 3rd day after surgery in both groups of participants.
  • The side effects of whey protein supplement, in the experimental group participants, which will evaluate include allergic reactions, nausea, vomiting, abdominal discomfort, bloating, headache, reduced appetite, elevated creatinine levels, and increased liver function levels on the 3rd day and two weeks after surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A Woman who suspected or diagnosed with ovarian and endometrial Cancer
  • A Woman who candidates for elective Surgical staging of Laparotomy operation in Rajavithi hospital
  • Aged 18-70 years old
  • Can communicate and understand Thai language very well
  • A woman voluntarily participated in the research

Exclusion criteria

  • Allergy to whey protein and protein product such as cow milk and egg
  • A Woman who diagnosed with Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Heart disease and Chronic liver disease
  • A Woman who expected difficult operation such as severe pelvic adhesion or required other surgeon for co-evaluation
  • Pregnant woman or breastfeeding
  • A Woman who denied surgery
  • A Woman who currently take a protein supplement
  • A Woman who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Bisphosphonates, Levodopa ,Tetracycline and Quinolone

Treatment and study plan

Whey Protein Supplement

Dietary Supplement

Participants are given Isolated whey protein supplement in evening before surgery and first day of post operation to compare with standard operative care on postoperative outcomes after gynecological cancer surgery

Primary outcomes

  1. Length of post-operative hospital stay

    Time frame: an average of 3 days after operation

    Length of post-operative hospital stay after operation to discharged

Secondary outcomes

  1. operative time

    Time frame: start to end of operation, an average of 3 hours

    To compare operative time between intervention group and control group

  2. ICU admission

    Time frame: an average of 3 days after operation

    Length of ICU admission after operation

  3. number of wound infection

    Time frame: 1 and 2 week after operation

    To compare number of wound infection after operation

  4. Readmission

    Time frame: 1 month after operation

    To compare readmission between intervention group and control group

  5. Level of serum albumin

    Time frame: one day before operation and 3 day after operation

    To compare serum albumin before operation and after operation

  6. Side effect of protein supplement

    Time frame: 3 day and 2 week after operation

    To study the side effect of protein supplement

  7. Unit of blood transfusion

    Time frame: start to end of operation, an average of 3 hours

    To compare unit of blood transfusion during operation between intervention group and control group

  8. Intraoperative complication

    Time frame: start to end of operation, an average of 3 hours

    To compare intraoperative complication

  9. postoperative complication

    Time frame: Any events occur within 14 days

    To compare postoperative complication between intervention group and control group

  10. Level of pain score

    Time frame: up to 3 days after operation

    To compare postoperative pain score

  11. time of first ambulation

    Time frame: up to 3 days after operation

    To compare time of first ambulation after operation

  12. time of first flatus and defecation

    Time frame: up to 3 days after operation

    To compare time of first flatus and defecation after operation

  13. Number of additional pain control drug

    Time frame: up to 3 days after operation

    To compare Number of additional pain control drug after operation

  14. Body temperature

    Time frame: Any events occur within 14 days

    To compare post operative fever after operation

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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