Comparison of Neutropenia in Gynecologic Cancer Patients Undergoing Chemotherapy between Immunonutrition and Standard Formula: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250615001

Enrollment

Registered

2025-06-15

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic cancer patients undergoing chemotherapy Neutropenia, Gynecologic Cancer Patients, Chemotherapy, Immunonutrition, Randomized controlled trial

Interventions

Neomune (Vanilla), 60g mixed in 200ml water (254 kcal) and supplements will be administered at 9.00 AM and 3.00 PM on Day 1 of chemotherapy cycles 1 2 and 3,Ensure (Vanilla), 53.8 g mixed in 200 ml wa

Experimental Dietary Supplement,Active Comparator Dietary Supplement

Immunonutrition,Standard Formula

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Participants diagnosed with female Gynecologic cancers, including ovarian, uterine, fallopian tube, vaginal, peritoneal, and cervical cancers. 2. Participants must receive first-cycle paclitaxel/carboplatin chemotherapy. 3. Participants must have a good performance status (ECOG 0 - 2). 4. Participants must be able to take oral nutrition independently. 5. Participants must have malnutrition classified as SGA class B or C. 6. Participants must be aged 18 - 80 years. 7. Participants must provide informed consent to participate. 8. Participants must be Thai nationals and able to communicate effectively in Thai.

Exclusion criteria

Exclusion criteria: 1. Participants with allergies to nutritional supplements or their components (dairy protein, soy products, or fish products). 2. Participants with organ dysfunction, including (Hepatic dysfunction, absolute neutrophil count less than 1,500/mm3, / or platelet count less than Renal failure creatinine clearance (CrCl) less than 30 ml/min (calculated by CKD - EPI formula). uncontrolled diabetes mellitus: HbA1C more than 9% 3. Participants receiving G-CSF 4. Participants with hematologic malignancies affecting white blood cells. 6. Participants who have received pelvic radiotherapy or prior chemotherapy. 7. Participants currently taking nutritional supplements for at least three months. 9. Pregnant or breastfeeding participants, and those who do not attend scheduled follow-ups.

Design outcomes

Primary

Measure	Time frame
Neutropenia before chemotherapy cycle 1,2,3,4 Blood for Complete Blood Count (CBC)	—

Secondary

Measure	Time frame
C-reactive protein before chemotherapy cycle 1,4 Blood for C-reactive protein,Nutritional status before chemotherapy cycle 1,4 SGA score,Neutrophil to Lymphocyte Ratio before chemotherapy cycle 1,2,3,4 calculated by dividing the absolute neutrophil count by the absolute lymphocyte count,Febrile neutropenia before chemotherapy cycle 2,3,4 using a combination of clinical assessment and laboratory testing, focusing on two key components: fever and neutropenia.,Adverse effect chemotherapy before chemotherapy cycle 2,3,4 WHO toxicity criteria	—

Measure

Time frame

C-reactive protein before chemotherapy cycle 1,4 Blood for C-reactive protein,Nutritional status before chemotherapy cycle 1,4 SGA score,Neutrophil to Lymphocyte Ratio before chemotherapy cycle 1,2,3,4 calculated by dividing the absolute neutrophil count by the absolute lymphocyte count,Febrile neutropenia before chemotherapy cycle 2,3,4 using a combination of clinical assessment and laboratory testing, focusing on two key components: fever and neutropenia.,Adverse effect chemotherapy before chemotherapy cycle 2,3,4 WHO toxicity criteria

—

Countries

Thailand

Contacts

Public ContactThitirath Thantiprechapong

Naungsung@gmail.com0820775989

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026