NCT07632482

Brief Summary

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant and distressing symptom experienced by cancer patients with different cancer types. Systematic reviews demonstrate that exercise is an effective non-pharmacological strategy for managing chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. Multimodal exercise was found to be superior to a single-modality exercise programme. However, the lack of using Information-Motivation-Behavioral Skill (IMB) model and addressing the social motivation component in current multimodal exercise programmes for cancer patients with solid tumors. Objectives: This study aims to evaluate the effects of a 6-week dance-based multimodal exercise program on CIPN symptoms over a 3-month period, comparing outcomes with usual care in cancer patients with solid tumors. Methods: An assessor-blinded pilot randomized controlled trial with process evaluation will be conducted at Community Cancer Centers/ Community Centers and Non-governmental organizations. A total of 76 participants will be recruited, with both intervention and control groups receiving educational booklets and logbooks. The intervention group will engage in a 6-week dance-based multimodal exercise program, supplemented by goal-setting evaluations and motivational messaging. The control group will receive weekly exercise videos and motivational messages. Outcomes, including CIPN severity, quality of life, pain, balance, exercise knowledge, motivation, self-efficacy, and adverse effects, will be measured using validated tools at baseline, immediately post-intervention, 4 weeks post-intervention, and 12 weeks post-intervention. Process evaluation will explore perceived benefits, program awareness, and facilitators and barriers to adherence. Conclusion: This study aims to provide an evidence-based approach for managing CIPN in cancer patients through a dance-based multimodal exercise program. It underscores the importance of incorporating the IMB model to enhance exercise adherence and support self-management of CIPN in cancer survivors.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable cancer

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 Progress7%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

May 27, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

cancersmalignant solid tumorschemotehrapy-induced peripheral neuropathyCIPN

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy-induced peripheral neuropathy.

    In the main randomized control trial, the primary outcome is chemotherapy-induced peripheral neuropathy (CIPN). The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) subscale contains 11 items measuring the CIPN symptoms on a 5-point Likert scale (from 0= not at all to 4= very much) . A higher score indicates the worse CIPN symptoms .

    from enrollment to 12 weeks after the intervention

Secondary Outcomes (5)

  • Neuropathic pain

    from enrollment to 12 weeks after the intervention

  • Quality of Life in cancer patients

    from enrollment to 12 weeks after the intervention

  • Anxiety

    from enrollment to 12 weeks after intervention

  • Balance

    from enrollment to 12 weeks after intervention

  • Knowledge of exercise, exercise motivation and exercise self-efficacy

    from enrollment to 12 weeks after intervention

Study Arms (2)

dance-based multimodal exercise

EXPERIMENTAL

Upon recruitment, participants will receive the exercise educational booklet and logbook. This study applies the Information-Motivation-Behavioral Skills (IMB) model in a six-week Zumba Gold dance program for cancer survivors. Each weekly 75-minute session includes vital sign checks, 50 minutes of multimodal exercise (warm-up, workout, cool-down), and group sharing. Dance styles taught are Merengue, Salsa, Cumbia, Belly dance, Flamenco, Tango, and cool-down, with revision in later sessions. Videos with safety guidance are shared via WhatsApp for home practice. Chair-based options are available for those with balance issues. Motivational support and tele-consultation by an oncology nurse provide ongoing guidance and symptom management to enhance self-efficacy in CIPN care.

Behavioral: dance-based multimodal exercise

Exercise education

ACTIVE COMPARATOR

Control group participants will receive an educational booklet and logbook, plus weekly WhatsApp exercise videos recommended by the Department of Health, HKSAR (Elderly Health Service, 2025) during the first six weeks. They are encouraged to follow NCCN and ACSM guidelines for cancer survivors: at least 150 minutes of moderate activity weekly, or 75 minutes vigorous, with warm-up and stretching before sessions. Stretching should occur on two non-resistance days, and resistance training 2-3 times weekly (2-3 sets of 10-15 reps, 2-3 minutes rest). For CIPN survivors, balance training is emphasized, with alternatives like cycling or water exercise. Encouragement messages follow in weeks 10 and 14.

Behavioral: Exercise education

Interventions

This study applies the Information-Motivation-Behavioral Skills (IMB) model in a six-week Zumba Gold dance program for cancer survivors. Each weekly 75-minute session includes vital sign checks, 50 minutes of multimodal exercise (warm-up, workout, cool-down), and group sharing. Dance styles taught are Merengue, Salsa, Cumbia, Belly dance, Flamenco, Tango, and cool-down, with revision in later sessions. Videos with safety guidance are shared via WhatsApp for home practice. Chair-based options are available for those with balance issues. Motivational support and tele-consultation by an oncology nurse provide ongoing guidance and symptom management to enhance self-efficacy in CIPN care.

dance-based multimodal exercise

Control group participants will receive an educational booklet and logbook, plus weekly WhatsApp exercise videos recommended by the Department of Health, HKSAR (Elderly Health Service, 2025) during the first six weeks. They are encouraged to follow NCCN and ACSM guidelines for cancer survivors: at least 150 minutes of moderate activity weekly, or 75 minutes vigorous, with warm-up and stretching before sessions. Stretching should occur on two non-resistance days, and resistance training 2-3 times weekly (2-3 sets of 10-15 reps, 2-3 minutes rest). For CIPN survivors, balance training is emphasized, with alternatives like cycling or water exercise. Encouragement messages follow in weeks 10 and 14.

Exercise education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients was diagnosed with malignant solid tumor (s) which is defined as abnormal, cancerous masses of tissue, for example, all carcinomas (such as breast cancer, stomach cancer, colorectal cancer and gynecological cancer, lung cancer and so on), sarcomas and lymphomas
  • Patients experience CIPN symptoms
  • Patients are able to use smart phone and WhatsApp
  • Patients are able to read or understand Chinese.

You may not qualify if:

  • Cancer patients suffer from severe organ failure or diseases that limit their level of activity
  • Patients are diagnosed with non-chemotherapy induced peripheral neuropathy, such as sciatica and diabetic neuropathy
  • Patients receive treatments that affect the severity of neuropathy, such as steroid, anticonvulsants and antidepressants
  • Patients age below 18 years old
  • Patients have cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (29)

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MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An independent assessor will be blinded for the allocation of the participants and intervention. Cancer patients who are fulfilling the eligibility criteria and willing to participate in the programme will be randomized in 1:1 ratio after the baseline measurement. Block randomization of a block of 4 will be used in the randomization process. Allocation numbers are concealed in opaque sealed envelopes which only the principal investigator will open them and inform the participants about the program details.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share