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

Postoperative Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035510
• Other study ID #: 143/2556
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Rajavithi Hospital
• Contact: Wiranchana Chitti, M.D.
• Phone: 022062900
• Email: wiranchanaparn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. Intraoperative outcomes, which include the duration of surgery, intraoperative blood loss, and intraoperative complications.

2. 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.

3. The nutritional status outcomes, assessed through serum albumin levels before surgery and on the 3rd day after surgery in both groups of participants.

4. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 31, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. A Woman who suspected or diagnosed with ovarian and endometrial Cancer

2. A Woman who candidates for elective Surgical staging of Laparotomy operation in Rajavithi hospital

3. Aged 18-70 years old

4. Can communicate and understand Thai language very well

5. A woman voluntarily participated in the research

Exclusion Criteria:

1. Allergy to whey protein and protein product such as cow milk and egg

2. A Woman who diagnosed with Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Heart disease and Chronic liver disease

3. A Woman who expected difficult operation such as severe pelvic adhesion or required other surgeon for co-evaluation

4. Pregnant woman or breastfeeding

5. A Woman who denied surgery

6. A Woman who currently take a protein supplement

7. A Woman who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Bisphosphonates, Levodopa ,Tetracycline and Quinolone

Related Conditions & MeSH terms

• Postoperative Outcomes

Intervention

Dietary Supplement:
• whey protein 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

Locations

Country	Name	City	State
Thailand	Rajavithi	Phaya Thai	Ratchathewi

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of post-operative hospital stay	Length of post-operative hospital stay after operation to discharged	an average of 3 days after operation
Secondary	operative time	To compare operative time between intervention group and control group	start to end of operation, an average of 3 hours
Secondary	ICU admission	Length of ICU admission after operation	an average of 3 days after operation
Secondary	number of wound infection	To compare number of wound infection after operation	1 and 2 week after operation
Secondary	Readmission	To compare readmission between intervention group and control group	1 month after operation
Secondary	Level of serum albumin	To compare serum albumin before operation and after operation	one day before operation and 3 day after operation
Secondary	Side effect of protein supplement	To study the side effect of protein supplement	3 day and 2 week after operation
Secondary	Unit of blood transfusion	To compare unit of blood transfusion during operation between intervention group and control group	start to end of operation, an average of 3 hours
Secondary	Intraoperative complication	To compare intraoperative complication	start to end of operation, an average of 3 hours
Secondary	postoperative complication	To compare postoperative complication between intervention group and control group	Any events occur within 14 days
Secondary	Level of pain score	To compare postoperative pain score	up to 3 days after operation
Secondary	time of first ambulation	To compare time of first ambulation after operation	up to 3 days after operation
Secondary	time of first flatus and defecation	To compare time of first flatus and defecation after operation	up to 3 days after operation
Secondary	Number of additional pain control drug	To compare Number of additional pain control drug after operation	up to 3 days after operation
Secondary	Body temperature	To compare post operative fever after operation	Any events occur within 14 days