Limiting Chemotherapy Side Effects by Using Moxa
Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study
1 other identifier
interventional
25
1 country
1
Brief Summary
This study investigates whether it is feasible to teach cancer patients undergoing chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects. Moxibustion is a therapy used in traditional Chinese medicine that uses heat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 24, 2016
May 1, 2016
11 months
May 6, 2016
May 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to moxa regimen assessed by Daily Moxa Diary
The primary aim of this study is to assess the feasibility of teaching cancer patients undergoing chemotherapy in the National Health Service (NHS) to self-administer daily indirect moxibustion to St 36 Zusanli, according to a protocol that begins ideally 7 to 10 days prior to the first chemotherapy cycle and continues until 21 days after the final chemotherapy cycle. Participants will complete a Daily Moxa Diary to record their adherence to the daily protocol. They will be asked also to log any days they miss, and give reasons why.
21 days after last chemotherapy cycle
Secondary Outcomes (7)
Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets
Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Variation to planned chemotherapy schedule
Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Chemotherapy related toxicities
Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Health related quality of life (HRQOL)
At Baseline, cycles 2, 3, and 6 (or final cycle), and one month after final cycle: typically Days 15, 29, 71, 127 for colorectal; Days 22, 43, 106, 134 for breast and gynaecological cancers
Patient self-management
At Baseline, cycle 3, and one month after final cycle: typically Days 29 and 127 for colorectal; Days 43 and 134 for breast and gynaecological cancers
- +2 more secondary outcomes
Study Arms (1)
Self administration of moxibustion
OTHERParticipants will be taught to self administer moxibustion to the acupuncture point Zusanli St-36, and apply it daily throughout their chemotherapy treatments
Interventions
Participants are taught to self administer moxibustion to acupuncture point Zusanli St-36 daily throughout the course of their chemotherapy
Eligibility Criteria
You may qualify if:
- with breast, gynaecologic, or colorectal cancer who are prescribed radical or adjuvant chemotherapy in the early disease setting, or first or second line chemotherapy is in the metastatic setting
- about to commence a course of chemotherapy for which granulocyte-colony stimulating factor (G-CSF) is not routinely indicated
- with a life expectancy of more than six months
- with blood cell counts within the normal range
- with calculated creatinine levels of ≥ 50ml/min
- English speaking
- able to understand instructions for self-administration of moxibustion and carry out the procedure
- able to give informed consent
You may not qualify if:
- having a haematological cancer diagnosis
- prescribed a chemotherapy regimen for which G-CSF is indicated
- having third or fourth line chemotherapy
- having metastatic bone cancer
- who have concomitant severe medical problems preventing participation
- with cognitive impairment that would impact participant's ability to safely administer self-moxibustion
- having renal dysfunction
- with lymphedema in the lower body.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Vernon Cancer Centre
Northwood, Middlesex, HS6 2RN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverley A de Valois, PhD
Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Acupuncturist
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 24, 2016
Study Start
February 1, 2016
Primary Completion
January 1, 2017
Study Completion
September 1, 2017
Last Updated
May 24, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share