Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

Trial Title: Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT05764447

Condition: Cancer
Chemotherapy-induced Peripheral Neuropathy

Conditions: Official terms:
Peripheral Nervous System Diseases

Conditions: Keywords:
cancer
neuropathy
acupressure
qigong
Baduanjin
chemotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Behavioral
Intervention name: Combined qigong Baduanjin and self-administered acupressure
Description: 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.
Arm group label: Combined Qigong Baduanjin and Self-administered Acupressure Intervention

Intervention type: Behavioral
Intervention name: Wait-list Control
Description: The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.
Arm group label: Wait-list Control Group

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.

Detailed description: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapy experiencing by cancer patients. CIPN can lead to significant distress, diminished health-related quality of life, functional decline, and an increased risk of falls in cancer patients, as they may experience altered proprioception. CIPN may continue to progress for several months post-treatment or even persist for years following chemotherapy. Current pharmacological approaches are limited not only by side effects (e.g., fatigue, dizziness, insomnia, or nausea) but also by patients' unwillingness to further medicate a drug-related side effect. Also, the drugs may treat pain but not non-painful CIPN symptoms, and cannot induce neuro-protection or neuro-regeneration. Non-pharmacological interventions may be more appealing to patients, as they usually have no side effects and may result in clinical benefits for CIPN sufferers. Acupressure is a non-invasive variant of acupuncture both adopting the meridian theory of traditional Chinese medicine (TCM) that stimulate acupoints across meridians and facilitate the flow of qi (energy) and blood, thereby restoring health and treating disease. Qigong is a mind-body exercise also rooted in the meridian theory of TCM. Through a combination of movement, breath control, and meditation, meridians can be opened, and the flow of qi and blood stimulated, to restore health. The combination approach is likely to elicit complementary physiologic adaptations on mechanisms involving both the peripheral and central nervous systems, thereby inducing a larger and potentially clinically meaningful improvement on CIPN.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - ≥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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: 000000
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Denise Shuk Ting Cheung, PhD

Phone: 3917 6673
Email: denisest@hku.hk

Start date: March 10, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: The University of Hong Kong
Agency class: Other

Source: The University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05764447