Limiting Chemotherapy Side Effects by Using Moxa

Breast Neoplasms Clinical Trial

Official title:

Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781155
• Other study ID #: RD2015-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 6, 2016
• Last updated: May 19, 2016
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2016
• Source: East and North Hertfordshire NHS Trust
• Contact: Clare Scarlett, BA (Hons)
• Phone: +44 203 826 2561
• Email: clare.scarlett1[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Description:

Chemotherapy drugs are used to treat cancer cells. However, they can also affect bone marrow and reduce the ability to make certain types of blood cells. Low white blood cell counts can leave patients vulnerable to infection. Low red blood cell counts can lead to anaemia and feelings of fatigue and weakness. Low platelet counts can lead to bruising and bleeding. Blood counts are therefore monitored. If they fall too low, the dose of chemotherapy may be reduced or the time between doses extended. This may affect survival as well as quality of life.

Research studies in China and the West suggest that moxibustion applied by a practitioner can improve blood counts and immunity, and reduce side effects of chemotherapy. Moxibustion (also called moxa) is a form of traditional Chinese medicine that uses heat to stimulate acupuncture points. This heat comes from a smouldering herb called mugwort, that is rolled into a cigar shape to gently warm the point. Many patients regard this as a pleasant, relaxing experience.

The researchers will teach patients to self-administer moxa to an acupuncture point just below the knee. This is a feasibility study to see if patients are willing and able to self-administer moxa daily throughout chemotherapy. Patients will keep a moxa diary to record their activity. The researchers will also use a questionnaire to assess whether patients see themselves as active managers of their health. This may help the researchers to screen suitable patients in future studies.

The researchers will also monitor blood counts, any delays or dose reductions to the chemotherapy, and any chemotherapy side effects. Participants will complete quality of life questionnaires at intervals during and after their chemotherapy.

If results are favourable, they will be used to design a randomised controlled trial comparing daily moxibustion with a "no treatment" control arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Genital Neoplasms, Female
• Neoplasms
• Toxicity Due to Chemotherapy

Intervention

Other:
• Moxibustion
Participants are taught to self administer moxibustion to acupuncture point Zusanli St-36 daily throughout the course of their chemotherapy

Locations

Country	Name	City	State
United Kingdom	Mount Vernon Cancer Centre	Northwood	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust	British Acupuncture Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets	Blood counts will be collected from the participants' medical notes to monitor incidents of neutropenia, anaemia, or thrombocytopenia.	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)	No
Secondary	Variation to planned chemotherapy schedule	Any delays in chemotherapy schedule and the reasons why will be collected from the participants' medical records	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)	No
Secondary	Chemotherapy related toxicities	Data will be collected from the participants' medical records, specifically the Common Terminology Criteria for Adverse Events (CTCAE), which is the standard form used in the Chemotherapy Suite to record information about any toxicities experienced by the patient resulting from chemotherapy (such as fatigue, vomiting, etc)	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)	No
Secondary	Health related quality of life (HRQOL)	The study will seek to identify changes in quality of life, to help with hypothesis generation for future studies. Validated questionnaires from the Functional Assessment for Cancer Therapy (FACT) will be used, including: FACT-G: a 27 item compilation of general questions covering physical, social/family, emotional and functional wellbeing; FACT-N: a 19-item neutropenia subscale designed to capture symptoms and impact on HRQOL related to neutropenia; FACT-An - a 20-item questionnaire assessing fatigue and anaemia-related concerns in people with cancer.	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	No
Secondary	Patient self-management	Patients with a high level of activation are likely to engage in positive health behaviours and participate in managing their health conditions more effectively. The Patient Activation Measure (PAM) will be used to explore whether it is possible to identify patients who will be most likely to follow a daily healthcare regimen.	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	No
Secondary	Safety assessed by all incidents including allergies, burns, and other accidents	The safety of moxibustion is under-reported in the literature. The researchers will monitor and record all incidents affecting safety, including allergies, burns, and other accidents	Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen	Yes
Secondary	Incidents of additional interventions administered as prophylaxis or therapy to maintain or improve blood counts	The researchers will record whether participants are taking or having therapies that affect blood cell counts, such as steroids, iron supplements and other dietary supplements as prophylaxis, or blood and platelet transfusions to improve low blood counts.	Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen	No