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Mulighetstesting av et tai chi-program for cellegiftindusert perifer nevropatibehandling (TCT)

18. september 2026 oppdatert av: Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute

This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).

Studieoversikt

Detaljert beskrivelse

This is a prospective, randomized, waitlist-controlled pilot trial to examine the suitability of the virtual Tai Chi program in cancer survivors with CIPN. Tai Chi is a mind-body practice that involves gentle body movements, meditation, and breathing techniques. It has proven to be effective in enhancing balance control and relieving musculoskeletal pains.

This study randomly assigns cancer survivors with CIPN with self-perceived balance difficulties to one of two groups: Group A Tai Chi Group versus Group B Waitlist Group. Randomization means a participant is placed into a study group by chance.

The research study procedures including screening for eligibility, questionnaires, and sensory and functional testing.

Participation in this study is expected to last for up to 12 weeks.

It is expected that about 21 people will take part in this research study.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Dana-Farber Cancer Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years old and older
  • Cancer survivors with no evidence of disease (cancer);
  • Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;
  • A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;
  • Answers "yes" to the following question: "Do you feel as though your balance is affected from experiencing CIPN?" or "Are you afraid of falling as a result of your CIPN?";
  • On a stable regimen (no change in past three months) if taking anti-neuropathy or other pain medications;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤ 2
  • Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, 2 in-person visits to Dana-Farber Cancer Institute (DFCI) (one within 2 weeks of enrollment and one at week 12);
  • Willing to adhere to requirement that no new pain medication be taken throughout the study period; and
  • Individuals receiving endocrine therapy or targeted/antibody therapy, such as trastuzumab, pertuzumab, or immunotherapy, will be eligible to participate.

Exclusion Criteria:

• Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A: Tai Chi Treatment Group

14 randomized participants will complete:

  • 1 baseline visit session.
  • Virtual Tai Chi session 2x weekly (60 minutes per session).
  • Independent Tai Chi sessions 3 days a week (60 minutes per session).
  • 12 week follow up visit.

12-week virtual Tai Chi program with experienced Tai Chi instructor. Sessions will be conducted via the HIPPA-compliant teleconference platform, Zoom.

Ingen inngripen: Arm B: Waitlist Control Group

7 randomized participants will complete:

  • 1 baseline visit session
  • Standard CIPN care prescribed by primary care physician/oncologist.
  • 12 week follow up visit
  • Participants will be offered 24 complimentary, virtual, Tai Chi training sessions over 12 weeks after completion of the 12-week follow-up visit.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Enrollment Rate for the Tai Chi Program
Tidsramme: 6 months

The intervention is considered feasible if 21 participants are enrolled within the first 6 months of the study period.

6 months
Assessment Completion Rate
Tidsramme: 12 weeks

The intervention is considered feasible if 75% of all evaluable participants, 16 out of 21, complete the biobehavioral assessments during the intervention period.

12 weeks
Session Completion Rate
Tidsramme: 12 weeks

The intervention is considered feasible if 62% of participants in the intervention arm, 9 out of 14, attend at least 80% or 20 of the 24 online sessions.

12 weeks
Acceptability of Intervention Measure (AIM) Score
Tidsramme: 12 weeks

Assessed by the Acceptability of the Intervention Measure (AIM), a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability.

12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Consent Rate (Arm A)
Tidsramme: Up to 6 months (based on total accrual duration)

Defined as the proportion of participants enrolled out of those eligible for study entry.

Up to 6 months (based on total accrual duration)
Consent Rate (Arm B)
Tidsramme: Up to 6 months (based on total accrual duration)

Defined as the proportion of participants enrolled out of those eligible for study entry.

Up to 6 months (based on total accrual duration)
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline and 12 weeks

Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.

Baseline and 12 weeks
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.

Baseline and 12 weeks
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline and 12 weeks

Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.

Baseline and 12 weeks
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.

Baseline and 12 weeks
Change in Fall Rate from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline and 12 weeks

Defined as the number of falls which occur during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.

Baseline and 12 weeks
Change in Fall Rate from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

Defined as the number of falls which occurred during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.

Baseline and 12 weeks
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline and 12 weeks

As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.

Baseline and 12 weeks
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.

Baseline and 12 weeks
Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline to 12 weeks

Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.

Baseline to 12 weeks
Change in TUG Test from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline to 12 weeks

Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.

Baseline to 12 weeks
Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline to 12 weeks

Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.

Baseline to 12 weeks
Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline to 12 weeks

Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.

Baseline to 12 weeks
Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline to 12 weeks

Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.

Baseline to 12 weeks
Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.

Baseline and 12 weeks
Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline and 12 weeks

This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings.

Baseline and 12 weeks
Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline and 12 weeks

This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings.

Baseline and 12 weeks
Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)
Tidsramme: Baseline to 12 weeks

This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.

Baseline to 12 weeks
Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)
Tidsramme: Baseline to 12 weeks

This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.

Baseline to 12 weeks
Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline to 12 weeks

Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.

Baseline to 12 weeks
Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline to 12 weeks

Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.

Baseline to 12 weeks
Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)
Tidsramme: Baseline to 12 weeks

The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.

Baseline to 12 weeks
Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)
Tidsramme: Baseline to 12 weeks

The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.

Baseline to 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Weidong Lu, MD, Dana-Farber Cancer Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. januar 2026

Primær fullføring (Antatt)

31. august 2028

Studiet fullført (Antatt)

31. oktober 2028

Datoer for studieregistrering

Først innsendt

29. januar 2025

Først innsendt som oppfylte QC-kriteriene

29. januar 2025

Først lagt ut (Faktiske)

4. februar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD-delingstidsramme

Data can be shared no earlier than 1 year following the date of publication

Tilgangskriterier for IPD-deling

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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