Vibration du corps entier pour l'amélioration de la santé et du fonctionnement des participants atteints de neuropathie périphérique induite par la chimiothérapie
Une nouvelle intervention thérapeutique pour restaurer la santé et le fonctionnement des personnes atteintes de neuropathie périphérique induite par la chimiothérapie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Oregon
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Portland, Oregon, États-Unis, 97239
- OHSU Knight Cancer Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: 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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Expérimental: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accrual
Délai: 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
Délai: 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
Délai: Up to 12-weeks
|
Compliance = % of each session completed. |
Up to 12-weeks
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Adverse events
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective physical function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kerri Winters-Stone, PhD, OHSU Knight Cancer Institute
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00018342
- STUDY00018342 (Autre identifiant: OHSU Knight Cancer Institute)
- NCI-2019-08961 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage IPD
Beginning 3 months following publication. No end date.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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