NCT07362147

Brief Summary

Paclitaxel-based drugs are commonly used adjuvant chemotherapy for gynecological cancer patients. Peripheral neuropathy, a side effect of this treatment, presents with symptoms such as numbness, tingling, decreased skin and reflex sensation, and impaired function in the hands and feet, thus affecting quality of life. Peripheral neuropathy is a side effect caused by the neurotoxicity of certain chemotherapeutic drugs, including paclitaxel and platinum-based drugs, resulting from the cumulative toxicity of specific drug doses. While numerous international studies have confirmed the preventative effects of hand and foot movement interventions, there is a lack of relevant literature in China. Therefore, this study aims to explore the effects of hand and foot movement interventions on elderly gynecological cancer patients undergoing chemotherapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Nov 2027

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 7, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

hand and foot exercises, chemotherapy, gynecological cancer, peripheral neuropathy, quality of life

Outcome Measures

Primary Outcomes (1)

  • Peripheral neuropathy

    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 Outcomes (1)

  • Quality of life

    From enrollment to end of treatment (12 weeks)

Study Arms (2)

control group

NO INTERVENTION

experimental group

EXPERIMENTAL
Other: hand and foot exercises

Interventions

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.

experimental group

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, No.201, Sec. 2, Shipai Rd., Beitou District, 112201, Taiwan

Location

Related Publications (1)

  • Eroglu I, Kutluturkan S. The effect of hand-foot exercises on chemotherapy-induced peripheral neuropathy-related pain, falls, and quality of life in colorectal cancer: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102641. doi: 10.1016/j.ejon.2024.102641. Epub 2024 Jun 15.

Related Links

MeSH Terms

Conditions

Peripheral Nervous System DiseasesUterine Cervical NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsVaginal NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVaginal DiseasesFallopian Tube Diseases

Study Officials

  • CHANG Chen Hsuan

    STUDY CHAIR

Central Study Contacts

CHANG Chen Hsuan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The experimental group received 12 weeks of hand and foot movement interventions (10-15 min/session \* 3 sessions/week).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations