| CTRI Number |
CTRI/2025/12/099380 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
We will analyse how many people who have cancer also have low levels of vitamin D in their body as they visit to Palliative Medicine Outpatient Department. |
|
Scientific Title of Study
|
Retrospective audit to identify the Vitamin D deficiency in cancer patients attending in Palliative Medicine Department |
| Trial Acronym |
Vitamin D and cancer pain |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOMNATH DEY |
| Designation |
Associate Professor |
| Affiliation |
MPMMCC and HBCH Tata Memorial Centre Varanasi |
| Address |
Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
07595802711 |
| Fax |
|
| Email |
drdeysomnath@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
SOMNATH DEY |
| Designation |
Associate Professor |
| Affiliation |
MPMMCC and HBCH Tata Memorial Centre Varanasi |
| Address |
Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
07595802711 |
| Fax |
|
| Email |
drdeysomnath@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
SOMNATH DEY |
| Designation |
Associate Professor |
| Affiliation |
MPMMCC and HBCH Tata Memorial Centre Varanasi |
| Address |
Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
07595802711 |
| Fax |
|
| Email |
drdeysomnath@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MPMMCC and HBCH, Varanasi,
Units of Tata Memorial Centre, Mumbai,
Department of Atomic Energy, Govt. of India.
Department of Pain and Palliative Medicine.
Banaras Hindu University, Campus, Sundar Bagiya Colony, Sundarpur, Varanasi, Uttar Pradesh. India Pin- 221005 |
|
|
Primary Sponsor
|
| Name |
MPMMCC and HBCH Varanasi UP India |
| Address |
Department of Pain and Palliative Medicine.
Mahamana Pandit Madan Mohan Malvia Cancer Centre.
Private OPD Room No 41 Ground Floor
BHU Campus, Sunderpur, Sundar Bagiya
Nariya
Varanasi
Uttar Pradesh
India
Pin 221005 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SOMNATH DEY |
MPMMCC and HBCH, Varanasi |
Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya
Varanasi Varanasi UTTAR PRADESH |
7595802711
drdeysomnath@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahamana Pandit Modan Mohan Malviya Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No human participant. only lab data based study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Demographic Data: Information on DMG, age, gender, diagnosis and any particular medical history.
2. Vitamin D3 Status: Measured through blood tests for 25-hydroxyvitamin D [25(OH)D] levels.
3. Sample size – 7000 (583 approx patients per month for 12 months duration) (Approximately 3500 patients seen per month in Palliative medicine department. Out of that nearly 500-600 patients per month was referred with serum Vitamin D level assessment. |
|
| ExclusionCriteria |
| Details |
Patient without diagnosis of cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Vitamin D levels associated with cancer patients visited in the palliative medicine OPD |
It will be measured only once at the first visit when patients come to OPD. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="6000" Sample Size from India="6000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prevalence of Vitamin D deficiency in cancer patients
attending in Palliative Medicine Department: Review
from a tertiary cancer centre
Introduction
Vitamin D, often
referred to as the "sunshine vitamin," plays a vital role in maintaining human health[1]. It plays a
crucial role in various physiological processes, including bone health,
immune function, and overall well-being. However, despite its recognized
importance, vitamin D deficiency remains a prevalent and underdiagnosed health
concern, affecting individuals across various demographic groups[2,3].
The practice of palliative care focuses on enhancing the
quality of life for individuals facing serious illnesses, offering
comprehensive support that encompasses physical, psychological, and emotional
well-being[4]. Addressing the nutritional needs of palliative care patients is an integral
part of this holistic approach. While much attention has been given to pain
management, symptom control, and emotional support in palliative care, the
nutritional aspects of care, including the assessment and management of vitamin
D deficiency, have not received the same level
of scrutiny.
Palliative care patients are at an increased risk of vitamin D deficiency due to reduced sun exposure, limited
mobility, and altered nutritional intake[5–7]. Vitamin D deficiency in palliative care patients may exacerbate their already compromised quality of life. Previous studies have shown that low levels of vitamin D in the blood may be associated
with pain, sensitivity to infection,
fatigue, depression, and lower self-rated quality of life[8,9]. Identifying and
addressing vitamin D deficiency can complement pain management strategies, potentially improving symptom control
and quality of life.
The relationship between vitamin D deficiency and
skeletal health is well- established[10]. In palliative care, where patients
may already experience frailty and limited mobility, the risk of fractures and
bone-related complications is heightened. Supplementation and strategies to
maintain optimal vitamin D levels could be instrumental in reducing skeletal
complications in this patient population.
Vitamin D deficiency can compromise the immune
system[11,12] potentially increasing the risk of infections in palliative care
patients who are already immunocompromised. Preventing infections and their
associated complications is paramount in palliative care, as infections can
lead to hospitalizations and worsen patients’ quality of life[9].
Multiple studies have been published showing vitamin D
deficiency among general population and few studies have focused on Vitamin D deficiency among palliative care patients. To our knowledge, no study
from South east Asian countries on vitamin D deficiency in palliative cancer patients have been published
.This comprehensive study aims to investigate the prevalence
of vitamin D deficiency in cancer
patients attending
in Palliative Medicine as outpatient. By shedding light
on this relatively understudied aspect of palliative care, we seek to provide
healthcare practitioners, researchers, and policymakers with a better
understanding of the role of vitamin
D in the well-being of these patients. Additionally, this study will explore whether
vitamin D supplementation, dietary adjustments, or increased exposure to
sunlight may offer practical solutions to mitigate the effects of deficiency, ultimately
improving the palliative care experience for patients facing serious illness.
Methodology
The study employs
a cross-sectional retrospective
observational design to examine the prevalence of vitamin D deficiency and its implications
in palliative care patients. This design allows for the collection of data at a single
point in time and offers
insights into the current status of vitamin D deficiency in this specific
patient population.
The study will be conducted at MPMMCC & HBCH VARANASI,
PAIN & PALLIATIVE MEDICINE DEPARTMENT which takes care of physical, social,
psychological and spiritual needs of cancer patients irrespective of their
disease trajectory. So, we have
accessibility to a diverse
group of patients from early palliative care
to end of life care.
Duration of study: Cancer patients
attended in Pain and Palliative Medicine OPD/IPD
during the period from June 2023 – November 2023, retrospectively the data will
be collected on a excel sheet from Biochemistry laboratory.
Data Collection
1. Demographic Data: Information on DMG, age, gender, diagnosis and any particular medical history.
2. Vitamin
D3 Status: Measured through blood tests for 25-hydroxyvitamin D [25(OH)D]
levels.
3. Sample size – 3000 (500 patients
per month for 6 months
duration)
5. Data Analysis - The data will be collected on excel
sheet from Biochemistry laboratory. Then collected
data will be analysed using appropriate statistical software. Descriptive statistics will be used to summarize
demographic characteristics, vitamin D levels.
Inferential statistics, such as t-tests and regression analysis, will be applied to assess the relationships between
vitamin D deficiency, opioid consumption and palliative care outcomes.
Discussion
To the extent of our knowledge, this is first of its
kind study in Northern and Central Northern part of India where we are going to
analyse the large number of cancer patient’s data on Vitamin D3 level attending
in Pain and Palliative Medicine Department of a tertiary care cancer hospital.
The clinical implications of this study are noteworthy.
Prior routine assessment of vitamin D levels should be incorporated into the
standard palliative care assessment and when deficiencies are identified,
healthcare providers can initiate interventions with vitamin D supplementation
and dietary modifications to improve patients’ nutritional status.
A clinical study revealed that more than 80% of
palliative cancer patients have serum levels
of 25-OHD below 50 nmol/L[5]. It could also be explained by the fact that many patients with cancer spend a large
portion of their time indoors
not taking varying
UVB exposure into account is a possible limitation of Vitamin D
deficiency.
There are a number of studies which examine and compare
the effects of Vitamin D levels in palliative care patients and the importance
of routine vitamin D assessments in
palliative care to identify and address deficiencies promptly [8,9,14].
Few studies suggest a role of vitamin
D in pain intensity and in
management of pain in varying clinical
settings[5,14,15]. A recent review of published RCTs concluded that a significantly greater
mean decrease in pain score could be observed with vitamin D supplementation
compared to placebo treatment in patients with chronic pain[16]. There is also
increasing evidence that vitamin D supplementation may reduce depressive
symptoms and improve quality of life[17].
Frankling et al in
a randomized controlled study concluded
that patients who received vitamin D supplements had a reduced
need for pain relief and lower levels
of fatigue in palliative cancer treatment.[9]
Since pharmacological
treatment options for fatigue in palliative
care are limited, and the evidence
bases for these treatments are weak [8,10],
the reported positive
effect of vitamin D is highly interesting and deserves further study
Few studies have reported both the endpoints
‘opioid-dose’ and ‘antibiotic consumption’ to be valuable, reliable and
clinically meaningful measurements for assessing therapeutic effects of vitamin
D in palliative care patients[5,8,18,19].
In palliative cancer
patients, infections as well as antibiotic treatment are frequent[20].
In a recent retrospective study 49 % of patients
were treated with antibiotics during
the last two weeks of life
which not only increases the hospital stay of the patients but also reduces the quality of life and adds to financial burden
[19].In a case controlled study of 39 patients the authors found improvement in
pain management and QoL within 4 weeks of initiation of vitamin D in palliative
cancer patients and decreased infection rate
in 3 months. The authors
also concluded that vitamin D supplementation in patients
with low serum levels of vitamin D can reduce the number
of days the patients were treated with antibiotics thereby reducing the risk of
multi-resistant bacteria[8].
Genetic polymorphism in
the vitamin D receptor and in genes metabolising vitamin D is widely
studied in relationship to cancer risk, musculoskeletal pain and infectious and autoimmune diseases[21]. Pain, infections and fatigue impair QoL in palliative cancer patients. Vitamin D is a
non-toxic substance that can be combined with most medications prescribed to
the palliative care patients. Therefore, Vitamin D supplementation is required to improve the well-being and decrease infections and pain.
That is why research is needed to explore the most effective vitamin D supplementation strategies and dosages in
palliative care, considering potential interactions with medications and
individual patient characteristics. However, this study has several
limitations, including the use of convenience sampling, which may introduce selection bias. Additionally, the cross-sectional design limits
our ability to establish causation and assess long-term changes in vitamin D
status. Future research could employ longitudinal designs to address these
limitations.
Conclusion
In conclusion, our comprehensive study will demonstrate
a significant prevalence of vitamin D deficiency in palliative care patients,
with potential implications for their quality
of life, skeletal health, and
immune function. The findings will underscore the importance of routinely assessing
vitamin D levels in palliative care and implementing interventions to address deficiencies. These measures have the potential
to enhance the palliative care experience and
improve the well-being of patients facing advanced illnesses. In our subsequent studies, we are planning
to analyse the correlation between different opioids sensitivity varies with Vitamin
D3 level and if
any improvement after Vitamin
D3 correction therapy.
Ethical Considerations
The study protocol
will be submitted for ethical committee
clearance before the start of the study.
Conflict of interest
None
|