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

26 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Integratore alimentare: 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.
Comparatore placebo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum Triglycerides (TG)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum LDL-C (mg/dL)
Baseline (Week 0), Week 8, Week 12, Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cancer-Related Fatigue - BFI-T Mean Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Week 0, 8, 12, 24
Serum CRP (mg/dL); systemic inflammatory marker
Week 0, 8, 12, 24
Alanine Aminotransferase (ALT/GPT)
Lasso di tempo: Week 0, 8, 12, 24
Serum ALT (U/L); hepatic injury marker
Week 0, 8, 12, 24
Aspartate Aminotransferase (AST/GOT)
Lasso di tempo: Week 0, 8, 12, 24
Serum AST (U/L)
Week 0, 8, 12, 24
Gamma-Glutamyl Transferase (γ-GT)
Lasso di tempo: Week 0, 8, 12, 24
Serum γ-GT (U/L); hepatic function marker
Week 0, 8, 12, 24

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum Interleukin-6 (IL-6)
Lasso di tempo: Week 0, 8, 12, 24
Serum IL-6 concentration (pg/mL) by ELISA
Week 0, 8, 12, 24
Gut Microbiota Alpha Diversity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 0, 8, 12, 24
Saliva 16S rRNA amplicon sequencing; alpha and beta diversity indices
Week 0, 8, 12, 24
Salivary Inflammatory Markers
Lasso di tempo: 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)
Lasso di tempo: Week 0, 4, 8, 12, 24
HRV index via smart wristband worn ≥24 hours per timepoint
Week 0, 4, 8, 12, 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Medical University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 maggio 2024

Completamento primario (Effettivo)

26 giugno 2026

Completamento dello studio (Effettivo)

26 giugno 2026

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TMU-N202305017oralcancer
  • N202305017 (Altro identificatore: Taipei Medical University)
  • N202407011 (Altro identificatore: Taipei Medical University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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