Whey ProteinNCT06035510
Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery
A study testing whey protein supplement in people with Whey Protein and Postoperative Outcomes, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Whey Protein, Postoperative Outcomes, Gynecological Cancer Surgery
- What is being tested?
- whey protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteThailand
- Study dates
- 21 Aug 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- 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.
- Being tested
- whey protein supplement
- Keywords
- Whey Protein, Postoperative outcomes, Gynecological Cancer Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein supplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| whey protein supplement | Experimental | Participants are given lactose-free Isolated whey protein 23 gm (containing with whey protein isolate 98.7 % ,Soya lecithin 1.3 % ) which mixed with water 350 ml at 6 p.m prior to surgery and 6.00 a.m. at first day after post surgery Receives: Dietary Supplement: whey protein supplement |
| standard operative care | No intervention | Participants followed standard operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of post-operative hospital stay
Length of post-operative hospital stay after operation to discharged
Measured: an average of 3 days after operation
Secondary outcomes (14)
operative time
To compare operative time between intervention group and control group
Measured: start to end of operation, an average of 3 hours
ICU admission
Length of ICU admission after operation
Measured: an average of 3 days after operation
number of wound infection
To compare number of wound infection after operation
Measured: 1 and 2 week after operation
Readmission
To compare readmission between intervention group and control group
Measured: 1 month after operation
Level of serum albumin
To compare serum albumin before operation and after operation
Measured: one day before operation and 3 day after operation
Side effect of protein supplement
To study the side effect of protein supplement
Measured: 3 day and 2 week after operation
Unit of blood transfusion
To compare unit of blood transfusion during operation between intervention group and control group
Measured: start to end of operation, an average of 3 hours
Intraoperative complication
To compare intraoperative complication
Measured: start to end of operation, an average of 3 hours
postoperative complication
To compare postoperative complication between intervention group and control group
Measured: Any events occur within 14 days
Level of pain score
To compare postoperative pain score
Measured: up to 3 days after operation
time of first ambulation
To compare time of first ambulation after operation
Measured: up to 3 days after operation
time of first flatus and defecation
To compare time of first flatus and defecation after operation
Measured: up to 3 days after operation
Number of additional pain control drug
To compare Number of additional pain control drug after operation
Measured: up to 3 days after operation
Body temperature
To compare post operative fever after operation
Measured: Any events occur within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start21 Aug 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whey ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035510
- Sponsor's protocol ID
- 143/2556
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery
- ClinicalTrials.gov ID
- NCT06035510
- Acronym / sponsor ID
- 143/2556
- Keywords
- Whey Protein, Postoperative outcomes, Gynecological Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whey protein supplement | Experimental | Dietary Supplement: whey protein supplementParticipants are given lactose-free Isolated whey protein 23 gm (containing with whey protein isolate 98.7 % ,Soya lecithin 1.3 % ) which mixed with water 350 ml at 6 p.m prior to surgery and 6.00 a.m. at first day after post surgery |
| standard operative care | No intervention | –Participants followed standard operative care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protein supplementParticipants 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 | Dietary supplement | whey protein supplement |
Primary outcome
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
14 secondary outcomes
operative time
Time frame: start to end of operation, an average of 3 hours
ICU admission
Time frame: an average of 3 days after operation
number of wound infection
Time frame: 1 and 2 week after operation
Readmission
Time frame: 1 month after operation
Level of serum albumin
Time frame: one day before operation and 3 day after operation
Side effect of protein supplement
Time frame: 3 day and 2 week after operation
Unit of blood transfusion
Time frame: start to end of operation, an average of 3 hours
Intraoperative complication
Time frame: start to end of operation, an average of 3 hours
postoperative complication
Time frame: Any events occur within 14 days
Level of pain score
Time frame: up to 3 days after operation
time of first ambulation
Time frame: up to 3 days after operation
time of first flatus and defecation
Time frame: up to 3 days after operation
Number of additional pain control drug
Time frame: up to 3 days after operation
Body temperature
Time frame: Any events occur within 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein supplement in people with Whey Protein and Postoperative Outcomes, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of post-operative hospital stay (time frame: an average of 3 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.