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Limiting Chemotherapy Side Effects by Using Moxa

E

East and North Hertfordshire NHS Trust

Status and phase

Unknown
Phase 2
Phase 1

Conditions

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

Treatments

Other: Moxibustion

Study type

Interventional

Funder types

Other

Identifiers

NCT02781155
RD2015-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Self administration of moxibustion
Other group
Description:
Participants will be taught to self administer moxibustion to the acupuncture point Zusanli St-36, and apply it daily throughout their chemotherapy treatments
Treatment:
Other: Moxibustion

Trial contacts and locations

1

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Central trial contact

Clare Scarlett, BA (Hons); Beverley A de Valois, PhD

Data sourced from clinicaltrials.gov

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