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

NCT07682285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-07-02

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Taiwanese Green Propolis

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2026-06-26
Completion
2026-06-26

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07682285 on ClinicalTrials.gov