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화학 요법 유발 말초 신경 병증 치료를위한 타이치 프로그램의 타당성 검사 (TCT)

2026년 9월 18일 업데이트: 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).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

21

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Dana-Farber Cancer Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Enrollment Rate for the Tai Chi Program
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Consent Rate (Arm A)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Weidong Lu, MD, Dana-Farber Cancer Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 16일

기본 완료 (추정된)

2028년 8월 31일

연구 완료 (추정된)

2028년 10월 31일

연구 등록 날짜

최초 제출

2025년 1월 29일

QC 기준을 충족하는 최초 제출

2025년 1월 29일

처음 게시됨 (실제)

2025년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 24-399

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .