Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

NCT05764447 | Completed

• 1 other identifier: UW22587
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate the effects of a 16-week combined qigong and acupressure intervention on reducing self-reported chemotherapy-induced peripheral neuropathy (CIPN) severity, objective measures of CIPN severity, lower-extremity functioning, handgrip strength, fall incidence, and health-related quality of life post-intervention among post-chemotherapy adult cancer patients. This will be a 2-arm assessor-blinded randomized controlled trial that will follow the CONSORT guidelines. A total of 104 cancer patients aged ≥18 who have completed neurotoxic chemotherapy at least 1 month prior to enrolment and experiencing CIPN will be recruited and randomized into combined qigong and self-administered acupressure intervention and wait-list control groups. The intervention group comprises of twice-weekly supervised group sessions and three times-weekly self-practice prescription (30 min each time) on days without group sessions. The control group will be offered a free modality of their choice after the last follow-up. The participants will receive usual care alone during the study period.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy

Keywords

cancer; neuropathy; acupressure; qigong; Baduanjin; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in self-reported CIPN severity post-intervention

  The 11-item version of Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG Ntx) subscale will be used. It covers four domains: sensory, motor, hearing, and dysfunction. Items are rated on a scale of 0 (not at all) to 4 (very much), with higher scores indicating more severe CIPN. The Chinese version of FACT/GOG-Ntx has demonstrated satisfactory reliability and validity.

  Change from baseline (week 0) to post-intervention (week 16)

Secondary Outcomes (6)

• Change in self-reported CIPN severity at follow-up

  Change from baseline to 12 weeks after the intervention ends (week 28)

• Objective CIPN severity

  Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)

• Handgrip strength

  Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)

• Lower-extremity physical functioning

  Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)

• Fall incidence

  post-intervention (week 16), 12 weeks after the intervention ends (week 28)

Study Arms (2)

Combined Qigong Baduanjin and Self-administered Acupressure Intervention

EXPERIMENTAL

The intervention will last 16 weeks, including twice-weekly supervised group sessions. The first 8 weeks will focus on training of qigong Baduanjin and self-administered acupressure. The duration of each group session will be 90 min. From week 9 onwards, the group sessions will be shortened to 60 min twice a week led by the BQ master. For self-practice prescription, participants will be instructed to practice the combined BQ and acupressure intervention three times a week (30 min each time) on the days without group sessions.

Behavioral: Combined qigong Baduanjin and self-administered acupressure

Wait-list Control Group

ACTIVE COMPARATOR

The control group will be offered a free modality of their choice after the last follow-up. The participants will receive usual care alone during the study period.

Behavioral: Wait-list Control

Interventions

Combined qigong Baduanjin and self-administered acupressure BEHAVIORAL

The intervention will combine Baduanjin (BQ) and acupressure. The general design of the combination intervention is for BQ to be performed first (20 min), followed by self-administered acupressure (10 min). BQ comprises eight simple standardized movements. The combination of these simple body movements, breath control, and mindful meditation is designed to improve qi function.The acupressure protocol comprises six acupoints, i.e., Hegu, Quchi, Zusanli, Sanyinjiao, Qihai, and Taichong, which are the most commonly used acupoints in acupuncture trials for relieving CIPN according to previous reviews. These acupoints, based on TCM theory, are beneficial for strengthening the origin of qi and directing its flow to the upper and lower extremities. A massage pen will be used to stimulate the acupoints because participants with CIPN may have difficulty applying pressure with their hands/fingers.

Combined Qigong Baduanjin and Self-administered Acupressure Intervention

Wait-list Control BEHAVIORAL

The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.

Wait-list Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• diagnosis of cancer
• completed neurotoxic chemotherapy at least 1 month prior to enrolment
• experiencing CIPN (defined as tingling, numbness, or pain in the extremities in the past week, on the basis of a score ≥4 on an 11-point numerical rating scale due to receiving neurotoxic chemotherapy)
• Eastern Cooperative Oncology Group performance status between 0 and 2
• able to communicate in Cantonese or Mandarin

You may not qualify if:

• they have psychiatric disorders or conditions that preclude practicing qigong or acupressure (e.g., recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalization, cannot walk independently)
• have regularly engaged in qigong or acupressure (\>once per week) in the previous 6 months
• are receiving acupuncture
• are pregnant or lactating
• have any infection/injury/ulcers around the acupoints, or had peripheral neuropathy before chemotherapy

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent randomizer will prepare a computer-generated list of random assignments in sealed, sequentially numbered opaque envelopes. To aid allocation concealment, permuted blocks of varying sizes with an allocation weight of 1:1 will be used. The randomizer will keep a secure copy of the randomization list, which will be concealed from all research personnel and participants. The statistician performing data analysis will be blinded. Although it is not feasible to blind the participants or intervention personnel to the group assignments, the outcome assessors will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 10, 2023
• Study Start: March 10, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 3 years after the manuscript on main findings is published.

Locations

HK (1)