Taiwanese Green Propolis for Lipid Profiles, Fatigue, and Quality of Life in Oral Cavity Cancer Survivors

NCT07682285 | Completed

• 3 other identifiers: TMU-N202305017oralcancerN202407011N202305017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study examined whether Taiwanese Green Propolis (TGP), a natural bee-derived supplement, can improve blood fat levels, reduce tiredness (fatigue), and improve quality of life in people who have completed treatment for oral cavity (mouth) cancer. People who had finished treatment for oral cavity squamous cell carcinoma (a type of mouth cancer) and were in the follow-up period were invited to participate. Participants were randomly assigned to take either 4 TGP capsules per day (2,000 mg/day total) or 4 identical-looking placebo capsules for 12 weeks. Neither participants nor the study team knew who received which capsules until after the study ended (double-blind). All participants were followed for a further 12 weeks after stopping the capsules. At the start and at Weeks 4, 8, 12, and 24, participants had blood tests to measure cholesterol, triglycerides, liver enzymes, and inflammation markers. They also completed questionnaires about fatigue (BFI-T), symptoms (ESAS-r), and quality of life (FACT-H\&N), and performed physical tests including grip strength and a 30-second sit-to-stand test. The study aimed to determine whether TGP can help manage the metabolic and fatigue-related problems common after oral cancer treatment, and to provide data for planning larger future trials. 25 participants were enrolled at a regional teaching hospital in northern Taiwan. Stool and saliva samples were also collected at each timepoint to assess gut and oral microbiota composition (16S rRNA sequencing) and salivary inflammatory markers. Heart rate variability was monitored via smart wristband (minimum 24 hours per timepoint).

Conditions

Head and Neck Squamous Cell Carcinoma; Dyslipidemias; Cancer-related Fatigue

Keywords

Taiwanese green propolis; propolis; oral cavity cancer survivors; cancer-related fatigue; lipid profiles; quality of life; dietary supplement; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Serum Triglycerides (TG)

  Fasting serum triglycerides (mg/dL)

  Baseline (Week 0), Week 8, Week 12, Week 24

• Total Cholesterol (TC)

  Fasting serum total cholesterol (mg/dL)

  Baseline (Week 0), Week 8, Week 12, Week 24

• High-Density Lipoprotein Cholesterol (HDL-C)

  Fasting serum HDL-C (mg/dL)

  Baseline (Week 0), Week 8, Week 12, Week 24

• Low-Density Lipoprotein Cholesterol (LDL-C)

  Fasting serum LDL-C (mg/dL)

  Baseline (Week 0), Week 8, Week 12, Week 24

Secondary Outcomes (9)

• Cancer-Related Fatigue - BFI-T Mean Score

  Week 0, 8, 12, 24

• Symptom Distress - ESAS-r Total Score

  Week 0, 4, 8, 12, 24

• Quality of Life - FACT-H&N Total Score

  Week 0, 8, 12, 24

• Grip Strength

  Week 0, 4, 8, 12, 24

• 30-Second Sit-to-Stand Test

  Week 0, 4, 8, 12, 24

Other Outcomes (6)

• Serum Interleukin-6 (IL-6)

  Week 0, 8, 12, 24

• Gut Microbiota Alpha Diversity

  Week 0, 8, 12, 24

• Gut Microbiota Composition and Beta Diversity

  Week 0, 8, 12, 24

Study Arms (2)

Taiwanese Green Propolis (TGP)

EXPERIMENTAL

Participants receive Taiwanese Green Propolis capsules (500 mg/capsule, 4 capsules/day divided as 2 capsules in the morning and 2 in the evening) for 12 weeks, providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds (propolin C, D, F, G, H)/day.

Dietary Supplement: Taiwanese Green Propolis

Placebo

PLACEBO COMPARATOR

Participants receive identical-appearing placebo capsules (4 capsules/day, divided as 2 capsules in the morning and 2 in the evening) for 12 weeks. Capsules are identical to TGP capsules in appearance, size, color, and smell but contain no active propolis constituents.

Other: Placebo

Interventions

Taiwanese Green Propolis DIETARY_SUPPLEMENT

Taiwanese Green Propolis (TGP) capsules derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae). Each capsule contains 500 mg TGP with approximately 50 mg propolin compounds. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks; total daily dose 2,000 mg TGP containing approximately 200 mg propolin compounds/day.

Taiwanese Green Propolis (TGP)

Placebo OTHER

Placebo capsules identical to TGP capsules in appearance, size, color, and smell, but containing inert excipients with no active propolis constituents. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Histologically confirmed diagnosis of oral cavity squamous cell carcinoma (OSCC)
• Post-primary treatment follow-up phase (surgery with or without adjuvant radiotherapy and/or chemotherapy completed)
• Alert and oriented; able to complete study assessments independently or with research staff assistance
• Able to communicate in Mandarin or Taiwanese
• Not chewing betel quid during the study period
• Willing to provide written informed consent

You may not qualify if:

• Known allergy to propolis, honey, multiple pollens, or alcohol
• Psychiatric disorder or cognitive impairment preventing study participation
• Neuromuscular or joint disorders preventing performance of grip strength or sit-to-stand assessments
• Pain at testing limb sites preventing physical assessments

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Lin CC, Chang AP, Chen ML, Cleeland CS, Mendoza TR, Wang XS. Validation of the Taiwanese version of the Brief Fatigue Inventory. J Pain Symptom Manage. 2006 Jul;32(1):52-9. doi: 10.1016/j.jpainsymman.2005.12.019.

  PMID: 16824985 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Dyslipidemias

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Taiwanese Green Propolis and placebo capsules were identical in appearance, size, color, and smell. Group allocation was concealed from participants, care providers, investigators, and outcome assessors until completion of the 24-week follow-up period, after which unblinding was performed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-arm parallel-group design. Participants were randomized 1:1 to receive either Taiwanese Green Propolis or identical placebo capsules for 12 weeks, with follow-up to Week 24.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: May 22, 2024
• Primary Completion: June 26, 2026
• Study Completion: June 26, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)