Fattibilità della digitopressione auricolare per l'appetito e il peso nei pazienti con carcinoma gastrico, esofageo e pancreatico in stadio II-IV
Uno studio controllato randomizzato che testa gli effetti di un intervento di digitopressione sull'appetito e sul peso nei pazienti con carcinoma gastrico, esofageo e pancreatico: uno studio pilota e di fattibilità
This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.
Panoramica dello studio
Stato
Condizioni
- Cancro al pancreas in stadio II AJCC v8
- Cancro al pancreas in stadio III AJCC v8
- Cancro al pancreas in stadio IV AJCC v8
- Cancro gastrico in stadio clinico III AJCC v8
- Cancro gastrico in stadio IV clinico AJCC v8
- Stadio clinico II Adenocarcinoma esofageo AJCC v8
- Carcinoma a cellule squamose dell'esofago in stadio II clinico AJCC v8
- Cancro gastrico in stadio clinico II AJCC v8
- Stadio clinico III Adenocarcinoma esofageo AJCC v8
- Stadio clinico III Carcinoma esofageo a cellule squamose AJCC v8
- Stadio clinico IV Adenocarcinoma esofageo AJCC v8
- Stadio clinico IV Carcinoma esofageo a cellule squamose AJCC v8
Descrizione dettagliata
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
ARM II: Patients receive usual care on study. Patients also undergo collection of blood samples on study.
After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18-65 years of age
- Stage II-IV gastric, esophageal, or pancreatic cancer
- Appetite score on visual analog scale ≤ 70/100
- At least 60 days of planned systemic treatment, whether already initiated or scheduled to be initiated
- Access to phone and electronic device for study contacts and questionnaires
- Willing and able to attend 4 in-person auricular acupressure treatments at the Fred Hutch South Lake Union Clinic
- Willing and able to perform 4 at-home self-applied treatments of auricular acupressure
- Participants must not have received acupressure or acupuncture for low appetite within last 30 days
- Participants must not be actively using corticosteroids, mirtazapine (Remeron), olanzapine (Zyprexa), or Marinol for appetite stimulation at baseline
- Participants must be able to intake food orally and not require sole or supplemental intravenous nutrition at baseline
- Participants must not have a history of physiological eating disorders (e.g., anorexia nervosa) in the last 3 years
- Participants must not have a current known or diagnosed immunodeficiency
- Participants must have an intact auricular pinna
- Able to understand and willing to sign written informed consent in English
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm I (acupressure therapy)
Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study. |
Ancillary studies
Altri nomi:
Undergo collection of blood samples
Altri nomi:
Receive usual care
Altri nomi:
Undergo auricular acupressure
Altri nomi:
|
|
Comparatore attivo: Arm II (usual care)
Patients receive usual care on study. Patients also undergo collection of blood samples on study. |
Ancillary studies
Altri nomi:
Undergo collection of blood samples
Altri nomi:
Receive usual care
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Accrual (Feasibility)
Lasso di tempo: Up to 2 years, during study accrual
|
Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period. |
Up to 2 years, during study accrual
|
|
Retention (Feasibility)
Lasso di tempo: Up to 8 weeks
|
Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit. |
Up to 8 weeks
|
|
Intervention Adherence (Feasibility)
Lasso di tempo: Up to 8 weeks
|
Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8. |
Up to 8 weeks
|
|
Intervention Fidelity (Feasibility)
Lasso di tempo: Up to 8 weeks
|
Fidelity will be assessed by study team adherence to symptom query and appropriate ear seed point modifications to the standard protocol and accuracy of seed placement according to photographic analysis. |
Up to 8 weeks
|
|
Acceptability (Feasibility)
Lasso di tempo: Up to 16 weeks
|
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews. |
Up to 16 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Appetite
Lasso di tempo: Baseline to week 4
|
As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4. The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response. |
Baseline to week 4
|
|
Change in Appetite
Lasso di tempo: Baseline to week 8
|
As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8. The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response. |
Baseline to week 8
|
|
Change in Body Weight (kg)
Lasso di tempo: Baseline to week 4
|
Analyses will assess change in each outcome as a change from baseline to week 4. |
Baseline to week 4
|
|
Change in Body Weight (kg)
Lasso di tempo: Baseline to week 8
|
Analyses will assess change in each outcome as a change from baseline to week 8. |
Baseline to week 8
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Blake Langley, Fred Hutch/University of Washington Cancer Consortium
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Neoplasie per sede
- Neoplasie
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie pancreatiche
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Terapie
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Qualità dell'assistenza sanitaria
- Terapie complementari
- Modalità di terapia fisica
- Indicatori di qualità, assistenza sanitaria
- Riabilitazione
- Linee guida come argomento
- Assicurazione della qualità, assistenza sanitaria
- Terapia, tessuto molle
- Manipolazioni muscoloscheletriche
- Standard di cura
- Gestione dei campioni
- Pratica le linee guida come argomento
- ACUPRESSURA
Altri numeri di identificazione dello studio
- RG1123492
- RG1123492 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2023-03942 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- 3KL2TR002317 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).
Periodo di condivisione IPD
Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.
Criteri di accesso alla condivisione IPD
Researchers and investigators who: 1) provide a methodologically sound proposal to expand on aims in the original, approved proposal; and/or 2) aim to conduct individual, participant-level meta-analyses. Proposals should be directed to blangley@fredhutch.org. To gain access, data requestors will need to sign a data access agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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