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NCT06807294 | NOT YET RECRUITING | Chemotherapy Induced Peripheral Neuropathy (CIPN)


Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
Sponsor:

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Ming Xiaoyang

Brief Summary:

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).

Condition or disease

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Peripheral Neuropathy Due to Chemotherapy

Peripheral Neuropathies

Intervention/treatment

Tai Chi Program

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 21 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2025-08-31
Estimated Study Completion Date : 2025-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Age \> 18 years old
  • * 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?" "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; and
  • * ECOG Performance Status Scale score ≤ 2
  • * Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, two separate in- person visits to DFCI and Osher Center within 2 weeks of enrollment, and separate in-person visits to DFCI and Osher Center at week 12, and no new pain medication allowed throughout the study period.
  • Note: Participants receiving endocrine therapy or targeted/antibody therapy (examples including trastuzumab, perturzumab, immunotherapy) will be eligible.
Exclusion Criteria
  • -Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.

Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)

Location Details

NCT06807294


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Locations


Not yet recruiting

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

Not yet recruiting

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

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