Vibrazione di tutto il corpo per il miglioramento della salute e del funzionamento nei partecipanti con neuropatia periferica indotta da chemioterapia
Un nuovo intervento terapeutico per ripristinare la salute e il funzionamento nelle persone con neuropatia periferica indotta da chemioterapia
This clinical trial studies how well whole body vibration works in improving the health and functioning of participants with chemotherapy-induced peripheral neuropathy. Peripheral neuropathy is a condition caused by exposure to chemotherapy drugs that may involve numbness/tingling and/or pain in the hands and feet, which can have adverse effects on daily life. Whole body vibration may cause weight loss and improve mobility and pain levels in cancer survivors who report symptoms of peripheral neuropathy.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the feasibility and safety of whole body vibration (WBV) in adult cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).
II. Determine the effect of WBV training on physical functioning in adult cancer survivors with CIPN.
III. Explore the effect of WBV training on symptom relief (neuropathy symptoms, pain, fatigue) and readiness to exercise in adult cancer survivors with CIPN.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (WBV): Participants complete two 10-minute WBV sessions per day, 7 days per week for 12 weeks.
GROUP II (USUAL CARE [UC]): Participants receive usual care and keep their same physical activity or dietary habits over 12 weeks.
After completion of study treatment, participants are followed up at 12 weeks.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- OHSU Knight Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically confirmed cancer stage I-IIIc (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- Previous chemotherapy within five years of enrollment (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- Presence of mild-very severe CIPN symptoms (confirmed by assessment using the Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE] criteria)
- Age 18 years or older at enrollment (confirmed by self-report on the Health History Questionnaire)
Exclusion Criteria:
- Body weight > 275 pounds (confirmed by self-report on the Health History Questionnaire)
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in low intensity exercise and/or WBV (confirmed by self-report on the Health History Questionnaire, and by physician clearance, if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible.)
- Presence of any known metastases (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- Adjuvant treatment for cancer within previous six weeks, other than hormone blocking, targeted or immunotherapy (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: Usual Care (UC)
Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire. |
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Sperimentale: Whole body vibration (WBV)
Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%. |
Undergo WBV
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Accrual
Lasso di tempo: Up to 12-weeks
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The number of participants enrolled during the recruitment period. |
Up to 12-weeks
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Adherence
Lasso di tempo: Up to 12-weeks
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Adherence = % of sessions attended and compliance = % of each session completed. |
Up to 12-weeks
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Compliance
Lasso di tempo: Up to 12-weeks
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Compliance = % of each session completed. |
Up to 12-weeks
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Adverse events
Lasso di tempo: Weekly up to 12-weeks
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An in-house survey will ask about adverse events (e.g., bone pain, nausea) that occur during the intervention. The number of discrete moderate and severe adverse events will be summed as a single variable. |
Weekly up to 12-weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective physical function
Lasso di tempo: 0, 12 weeks
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Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12. |
0, 12 weeks
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Functional mobility
Lasso di tempo: 0, 12 weeks
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Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 m, turn around and return and sit in the chair. |
0, 12 weeks
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Functional balance-sway velocity
Lasso di tempo: 0, 12 weeks
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Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway velocity (m/s) during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. |
0, 12 weeks
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Functional balance-sway area
Lasso di tempo: 0, 12 weeks
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Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway area (m2/s3) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. |
0, 12 weeks
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Functional balance-sway amount
Lasso di tempo: 0, 12 weeks
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Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the amount (m/s2) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. |
0, 12 weeks
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Symptoms of chemotherapy-induced peripheral neuropathy
Lasso di tempo: 0, 12 weeks
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Chronic changes in symptoms will be assessed at 0 and 12 weeks using the Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx). The questionnaire consists of the 27 item FACT-G, plus 11 items that specifically measure chemotherapy-induced neuropathy symptoms and concerns. Higher scores indicate worse symptoms. |
0, 12 weeks
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Fatigue Visual Analog Scale
Lasso di tempo: Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
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Fatigue overall will be measured both before and after each whole body vibration session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no fatigue) to 10 (worst fatigue). |
Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
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Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale
Lasso di tempo: 0, 12 weeks
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Chronic changes in fatigue will be assessed using the PROMIS Fatigue Scale. This instrument includes 8 items rated on a 5 point scale from "not at all" to "very much". Higher scores indicate worse fatigue. |
0, 12 weeks
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Pain Visual Analog Scale
Lasso di tempo: Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
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Pain in the feet will be assessed both before and after each session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no pain) to 10 (worst pain). |
Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
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Brief Pain Inventory
Lasso di tempo: 0, 12 weeks
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Chronic changes in pain will be assessed using the Brief Pain Inventory (BPI). The instrument has 2 subscales: pain severity and pain interference. Severity is determined by the average of 4 items rated from 0 (no pain) to 10 (pain as bad as you can imagine). Pain interference is determined by the average of 7 items rated from 0 (does not interfere) to 10 (completely interferes). |
0, 12 weeks
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Body mass index
Lasso di tempo: 0, 12 weeks
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Body mass index will be calculated as kg/m2. |
0, 12 weeks
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Exercise readiness
Lasso di tempo: 1, 12 weeks
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Exercise readiness will be assessed using the stage of change for exercise questionnaire. This is a categorical instrument with 5 options that indicate a person's readiness to engage in regular physical activity. Options that suggest engagement in more regular exercise are better. |
1, 12 weeks
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Perceived physical function
Lasso di tempo: 0, 12 weeks
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Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI). |
0, 12 weeks
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Gait
Lasso di tempo: 0, 12 weeks
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The number of meters that participants can walk in 6-minutes will be recorded. |
0, 12 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kerri Winters-Stone, PhD, OHSU Knight Cancer Institute
Pubblicazioni e link utili
Pubblicazioni generali
- Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Krasnow SM, Rubin CT, Roeland EJ, Horak FB, Stoyles SA, Dieckmann NF, Braun KN, Winters-Stone KM. Low-Intensity Vibration to Reduce Symptoms and Improve Physical Functioning in Cancer Survivors With Chemotherapy-Induced Peripheral Neuropathy: A Pilot Randomized Trial. JCO Oncol Pract. 2026 Jan;22(1):100-111. doi: 10.1200/OP-24-00961. Epub 2025 May 15.
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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
Altri numeri di identificazione dello studio
- STUDY00018342
- STUDY00018342 (Altro identificatore: OHSU Knight Cancer Institute)
- NCI-2019-08961 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
What data in particular will be shared? All individual quantitative participant data collected during the trial, after deidentification.
What other documents will be available? None
With whom? Investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.
For what types of analyses? To achieve aims in the approved proposal.
Periodo di condivisione IPD
Beginning 3 months following publication. No end date.
Criteri di accesso alla condivisione IPD
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement and be approved to receive the data by the OHSU IRB.
Informazioni su farmaci e dispositivi, documenti di studio
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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 .