- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362147
Exploring the Effects of Hand and Foot Exercise Intervention in Older Adults With Gynecological Cancer Receiving Chemotherapy Improvement of Peripheral Neuropathy and Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: CHANG Chen Hsuan
- Phone Number: +886 975800615
- Email: xuan851119@gmail.com
Study Locations
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-
No.201, Sec. 2, Shipai Rd., Beitou District
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Taipei, No.201, Sec. 2, Shipai Rd., Beitou District, Taiwan, 112201
- Taipei Veterans General Hospital
-
Contact:
- CHANG Chen Hsuan
- Phone Number: +886 975800615
- Email: xuan851119@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Individuals aged 65 or older diagnosed with gynecological cancer (stage II to IV) by a physician, without skin or nail lesions.
Individuals who have received at least one course of chemotherapy within the past year and have peripheral neuropathy, with chemotherapy drugs including paclitaxel (Paclitaxel or Docetaxel) or platinum-based drugs (Cisplatin or Carboplatin), and may receive combined targeted or immunotherapy.
Individuals who are conscious and able to communicate in Mandarin, Taiwanese, or written language.
Exclusion Criteria:
Skin or nail lesions. Edema of 3+ or more in the extremities. History of diagnosis of diabetes, neuropathy, peripheral arterial ischemia, or multiple organ failure.
Distal bone or skin metastases. Patients who have interrupted chemotherapy. Patients who have participated in similar studies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
The hand and foot exercise steps include hand and foot movements, practiced in a seated position.
Hold each movement for ten seconds and then relax, repeating ten times.
Perform the hand and foot exercises three times a day, for 10-15 minutes each time, three days a week, for twelve weeks.
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No Intervention: control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral neuropathy
Time Frame: From enrollment to the end of treatment at 12 weeks.
|
The content includes FACT/GOG-Ntx variable data.The maximum score is 120 points, and the minimum score is 0 points.A higher score indicates a better result.
|
From enrollment to the end of treatment at 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: From enrollment to end of treatment (12 weeks)
|
The content includes EORTC QLQ-CIPN20 variable data.The maximum score is 100 points, and the minimum score is 0 points.
A higher score indicates a better quality of life.
|
From enrollment to end of treatment (12 weeks)
|
Collaborators and Investigators
Investigators
- Study Chair: CHANG Chen Hsuan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Nervous System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neuromuscular Diseases
- Uterine Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Uterine Cervical Diseases
- Uterine Neoplasms
- Fallopian Tube Diseases
- Vaginal Diseases
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Peripheral Nervous System Diseases
- Endometrial Neoplasms
- Fallopian Tube Neoplasms
- Vaginal Neoplasms
Other Study ID Numbers
- 2025-12-008A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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