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Taiwanese Green Propolis for Lipid Profiles, Fatigue, and Quality of Life in Oral Cavity Cancer Survivors (TGP-OCS)

26. Juni 2026 aktualisiert von: Tsai-Wei Huang, Taipei Medical University

Effects of Taiwanese Green Propolis (2,000 mg/Day) on Lipid Profiles, Cancer-Related Fatigue, and Quality of Life in Post-Treatment Oral Cavity Squamous Cell Carcinoma Survivors: A Double-Blind, Randomized Controlled Trial

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Background:

Oral cavity squamous cell carcinoma (OSCC) survivors frequently experience persistent metabolic complications after treatment, including dyslipidemia, chronic low-grade inflammation, cancer-related fatigue (CRF), muscle weakness, and impaired quality of life. The prevalence of metabolic syndrome in this population substantially exceeds that of the general Taiwanese adult population.

Taiwanese green propolis (TGP), derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae), has a phytochemical profile distinct from Brazilian or Mediterranean propolis, comprising prenylated flavanones-principally propolin C, D, F, G, and H. These compounds have demonstrated hepatoprotective effects (TGF-β/Smad2/3 pathway), anti-inflammatory activity (NLRP3 inflammasome suppression), and lipid-metabolic regulatory properties in preclinical studies. No prior clinical trial has evaluated TGP in OSCC survivors.

Study Design:

Pilot double-blind, placebo-controlled, parallel-group randomized controlled trial (RCT). Intervention period: 12 weeks. Post-intervention follow-up: 12 weeks (total 24 weeks). Assessment timepoints: Week 0 (T0/baseline), Week 4 (T4), Week 8 (T8), Week 12 (T12), Week 24 (T24).

Intervention:

  • Experimental: TGP capsules (500 mg/capsule), 4 capsules/day (2 capsules BID), providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds/day; 12 weeks.
  • Control: Identical-appearing placebo capsules, 4 capsules/day, 12 weeks. Both capsules were identical in appearance, size, color, and smell.

Randomization and Blinding:

Computer-generated random number sequence with allocation concealment. Participants, care providers, investigators, and outcome assessors were blinded throughout the 24-week study period (quadruple blinding).

Primary Outcomes (T0, T8, T12, T24):

Total cholesterol (TC, mg/dL); Triglycerides (TG, mg/dL); High-density lipoprotein cholesterol (HDL-C, mg/dL); Low-density lipoprotein cholesterol (LDL-C, mg/dL).

Secondary Outcomes:

  • Cancer-related fatigue: BFI-T mean score (0-10); T0,T8,T12,T24
  • Symptom distress: ESAS-r total score (0-90); T0,T4,T8,T12,T24
  • Quality of life: FACT-H&N total score; T0,T8,T12,T24
  • Grip strength (kg), dominant hand, mean of 3 trials; T0,T4,T8,T12,T24
  • 30-second sit-to-stand test (repetitions); T0,T4,T8,T12,T24
  • C-reactive protein (CRP, mg/dL); T0,T8,T12,T24
  • Alanine aminotransferase (ALT/GPT, U/L); T0,T8,T12,T24
  • Aspartate aminotransferase (AST/GOT, U/L); T0,T8,T12,T24
  • Gamma-glutamyl transferase (γ-GT, U/L); T0,T8,T12,T24

Exploratory Outcomes:

Body weight, BMI, waist circumference, hip circumference, body fat %, hemoglobin, albumin, fasting glucose, HbA1c, BUN, creatinine, uric acid, WBC count, TSH, T3, T4. Serum interleukin-6 (IL-6, pg/mL); T0,T8,T12,T24. Gut microbiota alpha diversity (Shannon index) and beta diversity (Bray-Curtis dissimilarity) via stool 16S rRNA amplicon sequencing; T0,T8,T12,T24. Gut microbiota relative abundance of key bacterial taxa; T0,T8,T12,T24. Oral microbiota composition via saliva 16S rRNA amplicon sequencing; T0,T8,T12,T24. Salivary inflammatory markers including IL-6 (pg/mL); T0,T8,T12,T24. Heart rate variability: RMSSD and SDNN via smart wristband (minimum 24 hours per timepoint); T0,T4,T8,T12,T24.

Statistical Analysis:

Generalized Estimating Equations (GEE) with exchangeable working correlation structure; independent variables: group, time, and group × time interaction; adjusted for baseline values. Cohen's d calculated for significant interaction terms. Intent-to-treat (ITT) principle; N=25.

Sample Size:

Target: 62 participants (G*Power v3.1; repeated-measures ANOVA; f²=0.30; α=0.05; power=0.80; 10% dropout). Actual enrollment (pilot phase): 25.

Ethics:

Enrolment commenced in April 2024 under the original approved protocol N202305017 (approved 2023-05-22, Taipei Medical University Joint Institutional Review Board). A protocol amendment (N202407011, approved 2024-08-15) refined the inclusion criteria to focus on post-treatment oral cavity cancer survivors, designated lipid profiles as the primary outcome, and repositioned fatigue and quality of life as secondary outcomes. The amendment applied prospectively to all subsequently enrolled participants. Written informed consent was obtained from all participants prior to enrolment.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Taiwanese Green Propolis (TGP)
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.
Nahrungsergänzungsmittel: 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.
Placebo-Komparator: Placebo
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum Triglycerides (TG)
Zeitfenster: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum triglycerides (mg/dL)
Baseline (Week 0), Week 8, Week 12, Week 24
Total Cholesterol (TC)
Zeitfenster: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum total cholesterol (mg/dL)
Baseline (Week 0), Week 8, Week 12, Week 24
High-Density Lipoprotein Cholesterol (HDL-C)
Zeitfenster: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum HDL-C (mg/dL)
Baseline (Week 0), Week 8, Week 12, Week 24
Low-Density Lipoprotein Cholesterol (LDL-C)
Zeitfenster: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum LDL-C (mg/dL)
Baseline (Week 0), Week 8, Week 12, Week 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cancer-Related Fatigue - BFI-T Mean Score
Zeitfenster: Week 0, 8, 12, 24
Brief Fatigue Inventory-Taiwanese version; 9-item; mean score 0-10; higher = greater fatigue
Week 0, 8, 12, 24
Symptom Distress - ESAS-r Total Score
Zeitfenster: Week 0, 4, 8, 12, 24
Edmonton Symptom Assessment Scale-Revised; total score 0-90; higher = greater symptom burden
Week 0, 4, 8, 12, 24
Quality of Life - FACT-H&N Total Score
Zeitfenster: Week 0, 8, 12, 24
Functional Assessment of Cancer Therapy-Head and Neck; higher score = better quality of life
Week 0, 8, 12, 24
Grip Strength
Zeitfenster: Week 0, 4, 8, 12, 24
Dominant hand; mean of 3 trials with handheld dynamometer (kg)
Week 0, 4, 8, 12, 24
30-Second Sit-to-Stand Test
Zeitfenster: Week 0, 4, 8, 12, 24
Number of complete sit-to-stand repetitions in 30 seconds
Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Zeitfenster: Week 0, 8, 12, 24
Serum CRP (mg/dL); systemic inflammatory marker
Week 0, 8, 12, 24
Alanine Aminotransferase (ALT/GPT)
Zeitfenster: Week 0, 8, 12, 24
Serum ALT (U/L); hepatic injury marker
Week 0, 8, 12, 24
Aspartate Aminotransferase (AST/GOT)
Zeitfenster: Week 0, 8, 12, 24
Serum AST (U/L)
Week 0, 8, 12, 24
Gamma-Glutamyl Transferase (γ-GT)
Zeitfenster: Week 0, 8, 12, 24
Serum γ-GT (U/L); hepatic function marker
Week 0, 8, 12, 24

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum Interleukin-6 (IL-6)
Zeitfenster: Week 0, 8, 12, 24
Serum IL-6 concentration (pg/mL) by ELISA
Week 0, 8, 12, 24
Gut Microbiota Alpha Diversity
Zeitfenster: Week 0, 8, 12, 24
Stool 16S rRNA amplicon sequencing; Shannon index and observed species richness
Week 0, 8, 12, 24
Gut Microbiota Composition and Beta Diversity
Zeitfenster: Week 0, 8, 12, 24
Stool 16S rRNA sequencing; Bray-Curtis dissimilarity and relative abundance of key bacterial taxa
Week 0, 8, 12, 24
Oral Microbiota Composition
Zeitfenster: Week 0, 8, 12, 24
Saliva 16S rRNA amplicon sequencing; alpha and beta diversity indices
Week 0, 8, 12, 24
Salivary Inflammatory Markers
Zeitfenster: Week 0, 8, 12, 24
Salivary IL-6 and other cytokines (pg/mL) by multiplex immunoassay or ELISA
Week 0, 8, 12, 24
Heart Rate Variability (HRV)
Zeitfenster: Week 0, 4, 8, 12, 24
HRV index via smart wristband worn ≥24 hours per timepoint
Week 0, 4, 8, 12, 24

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Taipei Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Mai 2024

Primärer Abschluss (Tatsächlich)

26. Juni 2026

Studienabschluss (Tatsächlich)

26. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TMU-N202305017oralcancer
  • N202305017 (Andere Kennung: Taipei Medical University)
  • N202407011 (Andere Kennung: Taipei Medical University)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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